Acute Respiratory InfectionNeuBluMulNCT07883902
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
A study testing Expanded Diagnostic Strategy and Conventional Diagnostic Strategy in people with Acute Respiratory Infection, run by Santiago Lopez Gil at 1 site in Spain.
Trial summary
This study will evaluate whether an expanded diagnostic strategy can reduce antibiotic use in patients aged 65 years or older who are hospitalized with community-acquired acute respiratory infection, without negatively affecting clinical outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Respiratory Infection
- What is being tested?
- Expanded Diagnostic Strategy and Conventional Diagnostic Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Hospital admission to the Internal Medicine or Infectious Diseases ward for a community-acquired acute respiratory infection.
- Acute respiratory infection defined by the presence of at least two of the following criteria, with at least one being a clinical criterion:
- Clinical criteria: new-onset cough or worsening of pre-existing cough; purulent sputum production or changes in usual sputum characteristics; new-onset dyspnea or worsening of pre-existing dyspnea; pleuritic chest pain; abnormal respiratory sounds (crackles, rhonchi, or wheezing); fever (temperature ≥ 38°C) or hypothermia (temperature < 36°C).
- Laboratory criteria: leukocytosis (white blood cell count > 11,000/µL or neutrophil count > 8,200/µL) or C-reactive protein ≥ 20 mg/L.
- Radiological criteria: new pulmonary infiltrate or worsening of a pre-existing pulmonary infiltrate on chest imaging.
- No alternative diagnosis considered more likely to explain the clinical presentation, according to the treating physician.
Who cannot join
- Charlson Comorbidity Index ≥ 5.
- Imminent death with a life expectancy < 24 hours.
- Admission to the intensive care unit (ICU) directly from the Emergency Department or within the first 24 hours after admission to the hospital ward.
- Diagnosis of a solid-organ or hematologic malignancy with active oncologic treatment within the previous 3 months.
- Immune-mediated disease treated with immunosuppressive or immunomodulatory drugs.
- Transplant recipient.
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- Treatment with prednisone ≥ 20 mg/day (or equivalent) for ≥2 weeks.
- Human immunodeficiency virus (HIV) infection with an absolute CD4 count < 200 cells/µL.
- Profound neutropenia (< 100 cells/µL).
- Refusal to participate in the study or concurrent participation in another study.
- Previous inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital General Universitario de Elche
Elche, Alicante, 03203
Santiago López Gil, MD, +34 606 276 861, lopez_sangil@gva.es
About this study
Official title: Evaluation of an Expanded Diagnostic Strategy in Patients Aged 65 Years or Older Hospitalized With Community-Acquired Acute Respiratory Infection
This study will evaluate whether an expanded diagnostic strategy can reduce antibiotic use in patients aged 65 years or older who are hospitalized with community-acquired acute respiratory infection, without negatively affecting clinical outcomes.
The expanded diagnostic strategy combines multiplex respiratory polymerase chain reaction (PCR), serial procalcitonin measurements, and bedside lung ultrasound. The results of these tests will be integrated to support decisions about antibiotic treatment.
The study will compare the expanded diagnostic strategy with conventional diagnostic management. The main outcome will be the total duration of antibiotic therapy. The study will also assess the use of high-impact antibiotics, microbiological diagnosis, hospital and intensive care unit stay, complications, mortality, recurrence of infection, hospital readmissions, detection of multidrug-resistant microorganisms, and antibiotic-related adverse events.
Read the detailed description
This is a pragmatic, controlled, open-label, cluster-randomized crossover trial conducted in two hospital wards at Hospital General Universitario de Elche, Spain. The study population will consist of patients aged 65 years or older hospitalized with community-acquired acute respiratory infection.
The two hospital wards will constitute the study clusters. During the first two-month study period, one ward will be randomly assigned to the expanded diagnostic strategy and the other to the conventional diagnostic strategy. After a two-month washout period, the ward-level strategies will be crossed over for a second two-month study period. Individual participants will receive only the diagnostic strategy assigned to their hospital ward during the corresponding study period.
The expanded diagnostic strategy will include multiplex respiratory PCR using the BIOFIRE Pneumonia Panel plus, including detection of selected antimicrobial resistance genes; bedside lung ultrasound using the BLUE protocol; and serial procalcitonin measurements. The results will be integrated into a predefined diagnostic and therapeutic algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation.
Participants assigned to the conventional diagnostic strategy will receive usual diagnostic assessment and antimicrobial management. Etiological diagnostic tests will be performed according to routine clinical practice and at the discretion of the treating physician.
The primary objective is to determine whether the expanded diagnostic strategy reduces the total duration of antibiotic therapy compared with conventional diagnostic management. Secondary assessments will include high-impact antibiotic use, antibiotic escalation and de-escalation, microbiological diagnosis and time to diagnosis, detection of multidrug-resistant microorganisms, infectious complications, hospital and intensive care unit length of stay, intensive care unit admission, in-hospital and 30-day mortality, recurrence of infection requiring antimicrobial therapy, 30-day hospital readmission, and antibiotic-related adverse events.
An exploratory economic evaluation of the expanded diagnostic strategy is also planned from the perspective of the Spanish National Health System.
- Conditions
- Acute Respiratory Infection
- Being tested
- Expanded Diagnostic Strategy, Conventional Diagnostic Strategy
- Keywords
- Community-acquired respiratory infection, Older adults, Antimicrobial stewardship, Multiplex PCR, Procalcitonin, Lung ultrasound, Antibiotic therapy, Pneumonia, Antimicrobial resistance, Antibiotic optimization
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Diagnostic StrategyDiagnostic test
A protocolized diagnostic strategy combining multiplex respiratory PCR using the BIOFIRE Pneumonia Panel plus, bedside lung ultrasound using the BLUE protocol, and serial procalcitonin measurements. Diagnostic results are integrated into a predefined algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation.
Conventional Diagnostic StrategyDiagnostic test
Conventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests are performed at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Expanded Diagnostic Strategy | Experimental | Participants receive an expanded diagnostic strategy in addition to conventional diagnostic assessment. The strategy includes multiplex respiratory PCR, bedside lung ultrasound, and serial procalcitonin measurements. Results are integrated into a predefined diagnostic and therapeutic algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation. Receives: Diagnostic Test: Expanded Diagnostic Strategy |
| Conventional Diagnostic Strategy | Active comparator | Participants receive conventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests may be performed at the discretion of the treating physician. Receives: Diagnostic Test: Conventional Diagnostic Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Duration of Antibiotic Therapy
Total antibiotic exposure, calculated as the sum of days of therapy for all antibiotics received for the index acute respiratory infection, including antibiotic therapy administered during hospitalization and antibiotic therapy prescribed at hospital discharge. Each antibiotic received on a given calendar day contributes one day of therapy; therefore, days of concomitant antibiotic therapy are counted separately for each antibiotic.
Measured: From hospital admission through 30 days after hospital discharge
Secondary outcomes (22)
Duration of High Impact Antibiotic Therapy
Total exposure to high-impact antibiotics, calculated as the sum of days of therapy for all high-impact antibiotics received for the index acute respiratory infection. High-impact antibiotics are predefined as levofloxacin, moxifloxacin, piperacillin-tazobactam, ceftaroline, ceftobiprole, cefiderocol, cefepime, ceftazidime-avibactam, ceftolozane-tazobactam, carbapenems, vancomycin, and linezolid. Each antibiotic received on a given calendar day contributes one day of therapy; concomitant antibiotics are counted separately.
Measured: From hospital admission through 30 days after hospital discharge
Antibiotic De-escalation
Proportion of participants in whom antibiotic therapy is de-escalated during the index hospitalization or after discharge. Antibiotic de-escalation is defined as switching from a high-impact antibiotic to a low-impact antibiotic or discontinuing antibiotic therapy, according to the predefined classification in the study protocol.
Measured: From hospital admission through 30 days after hospital discharge
Antibiotic Escalation
Proportion of participants requiring escalation to high-impact antibiotic therapy for the index acute respiratory infection. Antibiotic escalation is defined as the need to change to an antibiotic classified as high-impact according to the predefined classification in the study protocol.
Measured: From hospital admission through 30 days after hospital discharge
Pathogen Detection by Pneumonia Panel PCR
Proportion of participants in whom at least one pathogen is detected by the multiplex pneumonia panel PCR performed on a respiratory sample.
Measured: Within the first 24 hours after hospital admission
Time to Microbiological Diagnosis
Time in hours from hospital admission to the availability of the microbiological result establishing the microbiological diagnosis.
Measured: From hospital admission to hospital discharge (assessed at 30 days after discharge)
Detection of Multidrug-Resistant Microorganisms
Proportion of participants in whom at least one multidrug-resistant microorganism is detected in any microbiological sample. Multidrug-resistant microorganisms are defined as methicillin-resistant Staphylococcus aureus (MRSA); Enterobacterales producing extended-spectrum beta-lactamases (ESBL), AmpC beta-lactamases, or carbapenemases; Pseudomonas aeruginosa resistant to at least one antibiotic in each of the following classes: penicillins, cephalosporins, carbapenems, fluoroquinolones, and aminoglycosides; carbapenem-resistant Acinetobacter baumannii; and Stenotrophomonas maltophilia.
Measured: From hospital admission through 30 days after hospital discharge
Respiratory Infection-Related Complications
Proportion of participants who develop at least one complication related to the index acute respiratory infection, including empyema, sepsis, lung abscess, acute respiratory distress syndrome, multiorgan failure, or venous thromboembolism.
Measured: From hospital admission through 30 days after hospital discharge
Hospital Length of Stay
Total number of days from hospital admission to hospital discharge.
Measured: From hospital admission to hospital discharge (assessed at 30 days after discharge)
Intensive Care Unit Admission
Proportion of participants requiring admission to the intensive care unit (ICU) during the index hospitalization.
Measured: From hospital admission to hospital discharge (assessed at 30 days after discharge)
Intensive Care Unit Length of Stay
Total number of days spent in the intensive care unit (ICU) during the index hospitalization among participants requiring ICU admission.
Measured: From hospital admission to hospital discharge (assessed at 30 days after discharge)
In-Hospital Mortality
Proportion of participants who die from any cause during the index hospitalization.
Measured: From hospital admission to hospital discharge (assessed at 30 days after discharge)
30-Day Mortality After Hospital Discharge
Proportion of participants who die from any cause within 30 days after hospital discharge.
Measured: Within 30 days after hospital discharge
Recurrence of Respiratory Infection Requiring Antibiotic Therapy
Proportion of participants who develop a new episode of respiratory infection requiring a new course of antibiotic therapy during the index hospitalization or within 30 days after hospital discharge.
Measured: From hospital admission through 30 days after hospital discharge
30-Day Hospital Readmission
Proportion of participants requiring hospital readmission for any cause within 30 days after hospital discharge.
Measured: Within 30 days after hospital discharge
Antibiotic-Related Adverse Events
Proportion of participants who experience at least one adverse event considered related to antibiotic therapy, including phlebitis and Clostridioides difficile infection.
Measured: From hospital admission through 30 days after hospital discharge
Healthcare Costs
Total direct healthcare costs associated with antimicrobial therapy and the diagnostic procedures included in the expanded diagnostic strategy. Costs will include antimicrobial therapy, serial procalcitonin measurements, bedside lung ultrasound, and multiplex pneumonia panel PCR testing.
Measured: From hospital admission through 30 days after hospital discharge
Cramér's V Coefficient for Association Between Lung Ultrasound BLUE Profile and Microbiological Diagnostic Category
The association between the presence or absence of a pneumonia-compatible lung ultrasound BLUE profile (ultrasound profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
Measured: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between PLAPS and Microbiological Diagnostic Category
The association between the presence or absence of posterolateral alveolar and/or pleural syndrome (PLAPS) on lung ultrasound (PLAPS present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
Measured: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between B' Profile and Microbiological Diagnostic Category
The association between the presence or absence of a B' lung ultrasound profile (B' profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
Measured: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between A/B Profile and Microbiological Diagnostic Category
The association between the presence or absence of an A/B lung ultrasound profile (A/B profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
Measured: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between C Profile and Microbiological Diagnostic Category
The association between the presence or absence of a C lung ultrasound profile (C profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
Measured: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between Pleural Effusion and Microbiological Diagnostic Category
The association between the presence or absence of pleural effusion on lung ultrasound (pleural effusion present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
Measured: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster-randomized crossover trial involving two hospital wards. During the first two-month study period, one ward is assigned to the expanded diagnostic strategy and the other to the conventional diagnostic strategy. Following a two-month washout period, the ward-level assignments are crossed over for a second two-month study period. Individual participants receive only the strategy assigned to their hospital ward during the corresponding study period.
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santiago Lopez Gil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Santiago Lopez Gil, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Félix Gutiérrez Rodero, MD, PhD, Study chair, Hospital General Universitario de Elche / Universidad Miguel HernándezMar Masiá Canuto, MD, PhD, Study chair, Hospital General Universitario de Elche / Universidad Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883902
- Sponsor's protocol ID
- 2025.106
- Acronym
- NeuBluMul
- Status last verified
- Nov 2026
- First submitted
- 3 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because a formal data-sharing plan has not been established for this study. Any future requests for data access would be evaluated in accordance with institutional policies, ethical requirements, and applicable data protection regulations.
Publications
Desai D, Shah AB, Dela JRC, Mugibel TA, Sumaily KM, Sabi EM, Mujamammi AH, Malafi ME, Alkaff SA, Alwahbi TA, Bahabara JO, Dahman LSB. Lung Ultrasonography Accuracy for Diagnosis of Adult Pneumonia: Systematic Review and Meta-Analysis. Adv Respir Med. 2024 Jun 4;92(3):241-253. doi: 10.3390/arm92030024.
PubMed 38921063Buchan BW, Windham S, Balada-Llasat JM, Leber A, Harrington A, Relich R, Murphy C, Dien Bard J, Naccache S, Ronen S, Hopp A, Mahmutoglu D, Faron ML, Ledeboer NA, Carroll A, Stone H, Akerele O, Everhart K, Bonwit A, Kwong C, Buckner R, Warren D, Fowler R, Chandrasekaran S, Huse H, Campeau S, Humphries R, Graue C, Huang A. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol. 2020 Jun 24;58(7):e00135-20. doi: 10.1128/JCM.00135-20. Print 2020 Jun 24.
PubMed 32350045Ito A, Ito I, Inoue D, Marumo S, Ueda T, Nakagawa H, Taki M, Nakagawa A, Tatsumi S, Nishimura T, Shiota T, Ishida T. The utility of serial procalcitonin measurements in addition to pneumonia severity scores in hospitalised community-acquired pneumonia: A multicentre, prospective study. Int J Infect Dis. 2020 Mar;92:228-233. doi: 10.1016/j.ijid.2020.01.018. Epub 2020 Jan 22.
PubMed 31981766Ye X, Xiao H, Chen B, Zhang S. Accuracy of Lung Ultrasonography versus Chest Radiography for the Diagnosis of Adult Community-Acquired Pneumonia: Review of the Literature and Meta-Analysis. PLoS One. 2015 Jun 24;10(6):e0130066. doi: 10.1371/journal.pone.0130066. eCollection 2015.
PubMed 26107512Poole S, Tanner AR, Naidu VV, Borca F, Phan H, Saeed K, Grocott MPW, Dushianthan A, Moyses H, Clark TW. Molecular point-of-care testing for lower respiratory tract pathogens improves safe antibiotic de-escalation in patients with pneumonia in the ICU: Results of a randomised controlled trial. J Infect. 2022 Dec;85(6):625-633. doi: 10.1016/j.jinf.2022.09.003. Epub 2022 Sep 9.
PubMed 36096312Moradi T, Bennett N, Shemanski S, Kennedy K, Schlachter A, Boyd S. Use of Procalcitonin and a Respiratory Polymerase Chain Reaction Panel to Reduce Antibiotic Use via an Electronic Medical Record Alert. Clin Infect Dis. 2020 Oct 23;71(7):1684-1689. doi: 10.1093/cid/ciz1042.
PubMed 31637442Abelenda-Alonso G, Calatayud L, Rombauts A, Meije Y, Oriol I, Sopena N, Padulles A, Niubo J, Duarte A, Llaberia J, Aranda J, Gudiol C, Satorra P, Tebe C, Ardanuy C, Carratala J. Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial. Nat Commun. 2024 Aug 17;15(1):7098. doi: 10.1038/s41467-024-51547-8.
PubMed 39154071Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
PubMed 37585220Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
PubMed 18403664
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Expanded Diagnostic Strategy in Patients Aged 65 Years or Older Hospitalized With Community-Acquired Acute Respiratory Infection
- ClinicalTrials.gov ID
- NCT07883902
- Acronym / sponsor ID
- NeuBluMul / 2025.106
- Conditions
- Acute Respiratory Infection
- Keywords
- Community-acquired respiratory infection, Older adults, Antimicrobial stewardship, Multiplex PCR, Procalcitonin, Lung ultrasound, Antibiotic therapy, Pneumonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Santiago Lopez GilUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether an expanded diagnostic strategy can reduce antibiotic use in patients aged 65 years or older who are hospitalized with community-acquired acute respiratory infection, without negatively affecting clinical outcomes.
The expanded diagnostic strategy combines multiplex respiratory polymerase chain reaction (PCR), serial procalcitonin measurements, and bedside lung ultrasound. The results of these tests will be integrated to support decisions about antibiotic treatment.
The study will compare the expanded diagnostic strategy with conventional diagnostic management. The main outcome will be the total duration of antibiotic therapy. The study will also assess the use of high-impact antibiotics, microbiological diagnosis, hospital and intensive care unit stay, complications, mortality, recurrence of infection, hospital readmissions, detection of multidrug-resistant microorganisms, and antibiotic-related adverse events.
Detailed description
This is a pragmatic, controlled, open-label, cluster-randomized crossover trial conducted in two hospital wards at Hospital General Universitario de Elche, Spain. The study population will consist of patients aged 65 years or older hospitalized with community-acquired acute respiratory infection.
The two hospital wards will constitute the study clusters. During the first two-month study period, one ward will be randomly assigned to the expanded diagnostic strategy and the other to the conventional diagnostic strategy. After a two-month washout period, the ward-level strategies will be crossed over for a second two-month study period. Individual participants will receive only the diagnostic strategy assigned to their hospital ward during the corresponding study period.
The expanded diagnostic strategy will include multiplex respiratory PCR using the BIOFIRE Pneumonia Panel plus, including detection of selected antimicrobial resistance genes; bedside lung ultrasound using the BLUE protocol; and serial procalcitonin measurements. The results will be integrated into a predefined diagnostic and therapeutic algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation.
Participants assigned to the conventional diagnostic strategy will receive usual diagnostic assessment and antimicrobial management. Etiological diagnostic tests will be performed according to routine clinical practice and at the discretion of the treating physician.
The primary objective is to determine whether the expanded diagnostic strategy reduces the total duration of antibiotic therapy compared with conventional diagnostic management. Secondary assessments will include high-impact antibiotic use, antibiotic escalation and de-escalation, microbiological diagnosis and time to diagnosis, detection of multidrug-resistant microorganisms, infectious complications, hospital and intensive care unit length of stay, intensive care unit admission, in-hospital and 30-day mortality, recurrence of infection requiring antimicrobial therapy, 30-day hospital readmission, and antibiotic-related adverse events.
An exploratory economic evaluation of the expanded diagnostic strategy is also planned from the perspective of the Spanish National Health System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster-randomized crossover trial involving two hospital wards. During the first two-month study period, one ward is assigned to the expanded diagnostic strategy and the other to the conventional diagnostic strategy. Following a two-month washout period, the ward-level assignments are crossed over for a second two-month study period. Individual participants receive only the strategy assigned to their hospital ward during the corresponding study period.
| Arm | Type | Receives |
|---|---|---|
| Expanded Diagnostic Strategy | Experimental | Diagnostic Test: Expanded Diagnostic StrategyParticipants receive an expanded diagnostic strategy in addition to conventional diagnostic assessment. The strategy includes multiplex respiratory PCR, bedside lung ultrasound, and serial procalcitonin measurements. Results are integrated into a predefined diagnostic and therapeutic algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation. |
| Conventional Diagnostic Strategy | Active comparator | Diagnostic Test: Conventional Diagnostic StrategyParticipants receive conventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests may be performed at the discretion of the treating physician. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 65 years.
- Hospital admission to the Internal Medicine or Infectious Diseases ward for a community-acquired acute respiratory infection.
- Acute respiratory infection defined by the presence of at least two of the following criteria, with at least one being a clinical criterion:
- Clinical criteria: new-onset cough or worsening of pre-existing cough; purulent sputum production or changes in usual sputum characteristics; new-onset dyspnea or worsening of pre-existing dyspnea; pleuritic chest pain; abnormal respiratory sounds (crackles, rhonchi, or wheezing); fever (temperature ≥ 38°C) or hypothermia (temperature < 36°C).
- Laboratory criteria: leukocytosis (white blood cell count > 11,000/µL or neutrophil count > 8,200/µL) or C-reactive protein ≥ 20 mg/L.
Key exclusion criteria (11 listed)
- Charlson Comorbidity Index ≥ 5.
- Imminent death with a life expectancy < 24 hours.
- Admission to the intensive care unit (ICU) directly from the Emergency Department or within the first 24 hours after admission to the hospital ward.
- Diagnosis of a solid-organ or hematologic malignancy with active oncologic treatment within the previous 3 months.
- Immune-mediated disease treated with immunosuppressive or immunomodulatory drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded Diagnostic StrategyA protocolized diagnostic strategy combining multiplex respiratory PCR using the BIOFIRE Pneumonia Panel plus, bedside lung ultrasound using the BLUE protocol, and serial procalcitonin measurements. Diagnostic results are integrated into a predefined algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation. | Diagnostic test | Expanded Diagnostic Strategy |
| Conventional Diagnostic StrategyConventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests are performed at the discretion of the treating physician. | Diagnostic test | Conventional Diagnostic Strategy |
Primary outcome
Total Duration of Antibiotic Therapy
Time frame: From hospital admission through 30 days after hospital discharge
Total antibiotic exposure, calculated as the sum of days of therapy for all antibiotics received for the index acute respiratory infection, including antibiotic therapy administered during hospitalization and antibiotic therapy prescribed at hospital discharge. Each antibiotic received on a given calendar day contributes one day of therapy; therefore, days of concomitant antibiotic therapy are counted separately for each antibiotic.
22 secondary outcomes
Duration of High Impact Antibiotic Therapy
Time frame: From hospital admission through 30 days after hospital discharge
Antibiotic De-escalation
Time frame: From hospital admission through 30 days after hospital discharge
Antibiotic Escalation
Time frame: From hospital admission through 30 days after hospital discharge
Pathogen Detection by Pneumonia Panel PCR
Time frame: Within the first 24 hours after hospital admission
Time to Microbiological Diagnosis
Time frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)
Detection of Multidrug-Resistant Microorganisms
Time frame: From hospital admission through 30 days after hospital discharge
Respiratory Infection-Related Complications
Time frame: From hospital admission through 30 days after hospital discharge
Hospital Length of Stay
Time frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)
Intensive Care Unit Admission
Time frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)
Intensive Care Unit Length of Stay
Time frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)
In-Hospital Mortality
Time frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)
30-Day Mortality After Hospital Discharge
Time frame: Within 30 days after hospital discharge
Recurrence of Respiratory Infection Requiring Antibiotic Therapy
Time frame: From hospital admission through 30 days after hospital discharge
30-Day Hospital Readmission
Time frame: Within 30 days after hospital discharge
Antibiotic-Related Adverse Events
Time frame: From hospital admission through 30 days after hospital discharge
Healthcare Costs
Time frame: From hospital admission through 30 days after hospital discharge
Cramér's V Coefficient for Association Between Lung Ultrasound BLUE Profile and Microbiological Diagnostic Category
Time frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between PLAPS and Microbiological Diagnostic Category
Time frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between B' Profile and Microbiological Diagnostic Category
Time frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between A/B Profile and Microbiological Diagnostic Category
Time frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between C Profile and Microbiological Diagnostic Category
Time frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between Pleural Effusion and Microbiological Diagnostic Category
Time frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 38921063Desai D, Shah AB, Dela JRC, Mugibel TA, Sumaily KM, Sabi EM, Mujamammi AH, Malafi ME, Alkaff SA, Alwahbi TA, Bahabara JO, Dahman LSB. Lung Ultrasonography Accuracy for Diagnosis of Adult Pneumonia: Systematic Review and Meta-Analysis. Adv Respir Med. 2024 Jun 4;92(3):241-253. doi: 10.3390/arm92030024.
- Background: PubMed 32350045Buchan BW, Windham S, Balada-Llasat JM, Leber A, Harrington A, Relich R, Murphy C, Dien Bard J, Naccache S, Ronen S, Hopp A, Mahmutoglu D, Faron ML, Ledeboer NA, Carroll A, Stone H, Akerele O, Everhart K, Bonwit A, Kwong C, Buckner R, Warren D, Fowler R, Chandrasekaran S, Huse H, Campeau S, Humphries R, Graue C, Huang A. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol. 2020 Jun 24;58(7):e00135-20. doi: 10.1128/JCM.00135-20. Print 2020 Jun 24.
- Background: PubMed 31981766Ito A, Ito I, Inoue D, Marumo S, Ueda T, Nakagawa H, Taki M, Nakagawa A, Tatsumi S, Nishimura T, Shiota T, Ishida T. The utility of serial procalcitonin measurements in addition to pneumonia severity scores in hospitalised community-acquired pneumonia: A multicentre, prospective study. Int J Infect Dis. 2020 Mar;92:228-233. doi: 10.1016/j.ijid.2020.01.018. Epub 2020 Jan 22.
- Background: PubMed 26107512Ye X, Xiao H, Chen B, Zhang S. Accuracy of Lung Ultrasonography versus Chest Radiography for the Diagnosis of Adult Community-Acquired Pneumonia: Review of the Literature and Meta-Analysis. PLoS One. 2015 Jun 24;10(6):e0130066. doi: 10.1371/journal.pone.0130066. eCollection 2015.
- Background: PubMed 36096312Poole S, Tanner AR, Naidu VV, Borca F, Phan H, Saeed K, Grocott MPW, Dushianthan A, Moyses H, Clark TW. Molecular point-of-care testing for lower respiratory tract pathogens improves safe antibiotic de-escalation in patients with pneumonia in the ICU: Results of a randomised controlled trial. J Infect. 2022 Dec;85(6):625-633. doi: 10.1016/j.jinf.2022.09.003. Epub 2022 Sep 9.
- Background: PubMed 31637442Moradi T, Bennett N, Shemanski S, Kennedy K, Schlachter A, Boyd S. Use of Procalcitonin and a Respiratory Polymerase Chain Reaction Panel to Reduce Antibiotic Use via an Electronic Medical Record Alert. Clin Infect Dis. 2020 Oct 23;71(7):1684-1689. doi: 10.1093/cid/ciz1042.
- Background: PubMed 39154071Abelenda-Alonso G, Calatayud L, Rombauts A, Meije Y, Oriol I, Sopena N, Padulles A, Niubo J, Duarte A, Llaberia J, Aranda J, Gudiol C, Satorra P, Tebe C, Ardanuy C, Carratala J. Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial. Nat Commun. 2024 Aug 17;15(1):7098. doi: 10.1038/s41467-024-51547-8.
- Background: PubMed 37585220Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
- Background: PubMed 18403664Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because a formal data-sharing plan has not been established for this study. Any future requests for data access would be evaluated in accordance with institutional policies, ethical requirements, and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Félix Gutiérrez Rodero, MD, PhD study chair
Hospital General Universitario de Elche / Universidad Miguel Hernández
Mar Masiá Canuto, MD, PhD study chair
Hospital General Universitario de Elche / Universidad Miguel Hernández
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Diagnostic Strategy and Conventional Diagnostic Strategy in people with Acute Respiratory Infection, run by Santiago Lopez Gil at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santiago López Gil, MD (+34 606 276 861, lopez_sangil@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Duration of Antibiotic Therapy (time frame: From hospital admission through 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07883902, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.