AspirationPhase 4NCT05079620
Early Antibiotics After Aspiration in ICU Patients
A Phase 4 study testing Ceftriaxone, Amoxicillin clavulanic acid and Cefepime in people with Aspiration and Aspiration Pneumonia, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of early antibiotics in ICU patients who appear to have aspirated, to help determine whether this improves outcomes by reducing the later incidence of pneumonia and other negative consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration, Aspiration Pneumonia
- What is being tested?
- Ceftriaxone, Amoxicillin clavulanic acid and Cefepime
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 12 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU
- Radiographic findings on chest x-ray or CT deemed by the treating ICU team to be consistent with aspiration (e.g. dependent infiltrates or intraluminal airway debris)
- Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event).
Who cannot join
- Already received 3 or more doses of any antibiotic since hospital presentation, unless the last dose was greater than 1 week before enrollment
- Requires antibiotic therapy for the treatment of other infections
- Patient "comfort measures only" at time of screening
- Currently participating in other trials using investigational drugs or interventions
- Currently pregnant
- Currently a prisoner
Show all 12Show fewer
- The consenting party (patient or their legally authorized representative) is unable to understand or read English at a fifth-grade level.
- 2 or more of the following are present at the time of screening:
- White blood cell count: ≥ 11.0
- Temperature ≥ 38.0C (100.4F)
- Purulent secretions
- S/F (pulse oximetry saturation to FiO2) ratio ≤ 215
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Health, John Dempsey Hospital
Farmington, Connecticut, 06030
About this study
Official title: Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration
The purpose of this study is to evaluate the use of early antibiotics in ICU patients who appear to have aspirated, to help determine whether this improves outcomes by reducing the later incidence of pneumonia and other negative consequences.
Read the detailed description
ICU patients with signs of aspiration on imaging and a clinical history supportive of aspiration, but with no clear signs of infectious pneumonia, will be randomized to receive either 5 days of empiric antibiotics or supportive care only. They will be followed for 30 days with a primary outcome of ICU length-of-stay and various secondary outcomes including mortality, ventilator days, and antibiotic days.
- Conditions
- Aspiration, Aspiration Pneumonia
- Being tested
- Ceftriaxone, Amoxicillin clavulanic acid, Cefepime, Vancomycin, Levofloxacin
- Keywords
- ventilator associated pneumonia
- Medical subject headings
- Pneumonia, Aspiration, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days
Amoxicillin clavulanic acidDrug
Also called Augmentin
At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days
CefepimeDrug
If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin
VancomycinDrug
If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (area under the curve/minimum inhibitory concentration) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if MRSA swab is negative.
LevofloxacinDrug
At any point after 24 hours, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg every 24 hours for the remainder of 5 days
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | 5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum.
Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin. Receives: Drug: Ceftriaxone; Drug: Amoxicillin clavulanic acid; Drug: Cefepime; Drug: Vancomycin; Drug: Levofloxacin |
| Control | No intervention | No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-free Days
Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.
Measured: From admission to 30 days, death, or hospital discharge, whichever occurs first
Secondary outcomes (16)
Ventilator-free Days
Number of days without any mechanical ventilation, between date of admission and 30 days afterwards. Death, discharge, or mechanical ventilation can both reduce this measure.
Measured: From admission to 30 days, death, or hospital discharge, whichever occurs first
Hospital-free Days
Number of days not spent in the hospital, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.
Measured: From admission to 30 days, death, or hospital discharge, whichever occurs first
Antibiotic-free Days
Number of days without any antibiotics administered, between date of admission and 30 days afterwards. Death, discharge, or antibiotic use can all reduce this measure.
Measured: Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Intubated After Enrollment
Yes/no
Measured: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Who Underwent Tracheostomy After Enrollment
Yes/no
Measured: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Who Developed Pneumonia After Enrollment
Yes/no, by criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Measured: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Days Before Developing Pneumonia Criteria
By criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Measured: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Prescribed Additional Antibiotics After Enrollment
Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics.
Measured: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Positive Sputum Culture With a Presumed Pathogen
Yes/no
Measured: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With Any Positive Culture With an Organism Resistant to Prophylactic Antibiotics
Yes/no
Measured: Between admission and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Positive C. Difficile Stool Toxin Assay After Enrollment
Yes/no
Measured: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Temperature >38 Centigrade on Day 3
Yes/no
Measured: Day 3 after enrollment
Number of Participants With a White Blood Cell Count >11k on Day 3
Yes/no
Measured: Day 3 after enrollment
Number of Participants With Arterial Oxygen Saturation / Fraction of Inspired Oxygen (S/F) <215 on Day 3
Yes/no
Measured: Day 3 after enrollment
Number of Participants With Purulent Secretions on Day 3
Yes/no
Measured: Day 3 after enrollment
30 Day Mortality
Death within 30 days from enrollment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start30 Nov 2021
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Why it stopped: Under-enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AspirationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Metersky, UConn Health
- Investigators
- Brandon Oto, Study director, UConn Health, Adult Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079620
- Sponsor's protocol ID
- 22-004-02
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2021
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dragan V, Wei Y, Elligsen M, Kiss A, Walker SAN, Leis JA. Prophylactic Antimicrobial Therapy for Acute Aspiration Pneumonitis. Clin Infect Dis. 2018 Aug 1;67(4):513-518. doi: 10.1093/cid/ciy120.
PubMed 29438467Acquarolo A, Urli T, Perone G, Giannotti C, Candiani A, Latronico N. Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study. Intensive Care Med. 2005 Apr;31(4):510-6. doi: 10.1007/s00134-005-2585-5. Epub 2005 Mar 8.
PubMed 15754197DiBardino DM, Wunderink RG. Aspiration pneumonia: a review of modern trends. J Crit Care. 2015 Feb;30(1):40-8. doi: 10.1016/j.jcrc.2014.07.011. Epub 2014 Jul 22.
PubMed 25129577El-Solh AA, Pietrantoni C, Bhat A, Aquilina AT, Okada M, Grover V, Gifford N. Microbiology of severe aspiration pneumonia in institutionalized elderly. Am J Respir Crit Care Med. 2003 Jun 15;167(12):1650-4. doi: 10.1164/rccm.200212-1543OC. Epub 2003 Apr 10.
PubMed 12689848Francois B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefeve G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379.
PubMed 31693806Lascarrou JB, Lissonde F, Le Thuaut A, Bachoumas K, Colin G, Henry Lagarrigue M, Vinatier I, Fiancette M, Lacherade JC, Yehia A, Joret A, Lebert C, Bourdon S, Martin Lefevre L, Reignier J. Antibiotic Therapy in Comatose Mechanically Ventilated Patients Following Aspiration: Differentiating Pneumonia From Pneumonitis. Crit Care Med. 2017 Aug;45(8):1268-1275. doi: 10.1097/CCM.0000000000002525.
PubMed 28594680Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.
PubMed 31573350Marik PE. Aspiration syndromes: aspiration pneumonia and pneumonitis. Hosp Pract (1995). 2010 Feb;38(1):35-42. doi: 10.3810/hp.2010.02.276.
PubMed 20469622Marik PE, Careau P. The role of anaerobes in patients with ventilator-associated pneumonia and aspiration pneumonia: a prospective study. Chest. 1999 Jan;115(1):178-83. doi: 10.1378/chest.115.1.178.
PubMed 9925081Rebuck JA, Rasmussen JR, Olsen KM. Clinical aspiration-related practice patterns in the intensive care unit: a physician survey. Crit Care Med. 2001 Dec;29(12):2239-44. doi: 10.1097/00003246-200112000-00001.
PubMed 11801813Sirvent JM, Torres A, El-Ebiary M, Castro P, de Batlle J, Bonet A. Protective effect of intravenously administered cefuroxime against nosocomial pneumonia in patients with structural coma. Am J Respir Crit Care Med. 1997 May;155(5):1729-34. doi: 10.1164/ajrccm.155.5.9154884.
PubMed 9154884Valles J, Peredo R, Burgueno MJ, Rodrigues de Freitas AP, Millan S, Espasa M, Martin-Loeches I, Ferrer R, Suarez D, Artigas A. Efficacy of single-dose antibiotic against early-onset pneumonia in comatose patients who are ventilated. Chest. 2013 May;143(5):1219-1225. doi: 10.1378/chest.12-1361.
PubMed 23715136
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration
- ClinicalTrials.gov ID
- NCT05079620
- Acronym / sponsor ID
- 22-004-02
- Conditions
- Aspiration, Aspiration Pneumonia
- Keywords
- ventilator associated pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Under-enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of early antibiotics in ICU patients who appear to have aspirated, to help determine whether this improves outcomes by reducing the later incidence of pneumonia and other negative consequences.
Detailed description
ICU patients with signs of aspiration on imaging and a clinical history supportive of aspiration, but with no clear signs of infectious pneumonia, will be randomized to receive either 5 days of empiric antibiotics or supportive care only. They will be followed for 30 days with a primary outcome of ICU length-of-stay and various secondary outcomes including mortality, ventilator days, and antibiotic days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Drug: Ceftriaxone, Drug: Amoxicillin clavulanic acid, Drug: Cefepime, Drug: Vancomycin, Drug: Levofloxacin5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum. Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin. |
| Control | No intervention | –No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU
- Radiographic findings on chest x-ray or CT deemed by the treating ICU team to be consistent with aspiration (e.g. dependent infiltrates or intraluminal airway debris)
- Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event).
Key exclusion criteria (12 listed)
- Already received 3 or more doses of any antibiotic since hospital presentation, unless the last dose was greater than 1 week before enrollment
- Requires antibiotic therapy for the treatment of other infections
- Patient "comfort measures only" at time of screening
- Currently participating in other trials using investigational drugs or interventions
- Currently pregnant
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 |
|---|---|---|
| CeftriaxoneIf there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days | Drug | Antibiotics |
| Amoxicillin clavulanic acidAlso: AugmentinAt any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days | Drug | Antibiotics |
| CefepimeIf there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin | Drug | Antibiotics |
| VancomycinIf there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (area under the curve/minimum inhibitory concentration) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if MRSA swab is negative. | Drug | Antibiotics |
| LevofloxacinAt any point after 24 hours, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg every 24 hours for the remainder of 5 days | Drug | Antibiotics |
Primary outcome
ICU-free Days
Time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first
Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.
16 secondary outcomes
Ventilator-free Days
Time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first
Hospital-free Days
Time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first
Antibiotic-free Days
Time frame: Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Intubated After Enrollment
Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Who Underwent Tracheostomy After Enrollment
Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Who Developed Pneumonia After Enrollment
Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Days Before Developing Pneumonia Criteria
Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Prescribed Additional Antibiotics After Enrollment
Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Positive Sputum Culture With a Presumed Pathogen
Time frame: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With Any Positive Culture With an Organism Resistant to Prophylactic Antibiotics
Time frame: Between admission and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Positive C. Difficile Stool Toxin Assay After Enrollment
Time frame: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Temperature >38 Centigrade on Day 3
Time frame: Day 3 after enrollment
Number of Participants With a White Blood Cell Count >11k on Day 3
Time frame: Day 3 after enrollment
Number of Participants With Arterial Oxygen Saturation / Fraction of Inspired Oxygen (S/F) <215 on Day 3
Time frame: Day 3 after enrollment
Number of Participants With Purulent Secretions on Day 3
Time frame: Day 3 after enrollment
30 Day Mortality
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29438467Dragan V, Wei Y, Elligsen M, Kiss A, Walker SAN, Leis JA. Prophylactic Antimicrobial Therapy for Acute Aspiration Pneumonitis. Clin Infect Dis. 2018 Aug 1;67(4):513-518. doi: 10.1093/cid/ciy120.
- Background: PubMed 15754197Acquarolo A, Urli T, Perone G, Giannotti C, Candiani A, Latronico N. Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study. Intensive Care Med. 2005 Apr;31(4):510-6. doi: 10.1007/s00134-005-2585-5. Epub 2005 Mar 8.
- Background: PubMed 25129577DiBardino DM, Wunderink RG. Aspiration pneumonia: a review of modern trends. J Crit Care. 2015 Feb;30(1):40-8. doi: 10.1016/j.jcrc.2014.07.011. Epub 2014 Jul 22.
- Background: PubMed 12689848El-Solh AA, Pietrantoni C, Bhat A, Aquilina AT, Okada M, Grover V, Gifford N. Microbiology of severe aspiration pneumonia in institutionalized elderly. Am J Respir Crit Care Med. 2003 Jun 15;167(12):1650-4. doi: 10.1164/rccm.200212-1543OC. Epub 2003 Apr 10.
- Background: PubMed 31693806Francois B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefeve G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379.
- Background: PubMed 28594680Lascarrou JB, Lissonde F, Le Thuaut A, Bachoumas K, Colin G, Henry Lagarrigue M, Vinatier I, Fiancette M, Lacherade JC, Yehia A, Joret A, Lebert C, Bourdon S, Martin Lefevre L, Reignier J. Antibiotic Therapy in Comatose Mechanically Ventilated Patients Following Aspiration: Differentiating Pneumonia From Pneumonitis. Crit Care Med. 2017 Aug;45(8):1268-1275. doi: 10.1097/CCM.0000000000002525.
- Background: PubMed 31573350Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.
- Background: PubMed 20469622Marik PE. Aspiration syndromes: aspiration pneumonia and pneumonitis. Hosp Pract (1995). 2010 Feb;38(1):35-42. doi: 10.3810/hp.2010.02.276.
- Background: PubMed 9925081Marik PE, Careau P. The role of anaerobes in patients with ventilator-associated pneumonia and aspiration pneumonia: a prospective study. Chest. 1999 Jan;115(1):178-83. doi: 10.1378/chest.115.1.178.
- Background: PubMed 11801813Rebuck JA, Rasmussen JR, Olsen KM. Clinical aspiration-related practice patterns in the intensive care unit: a physician survey. Crit Care Med. 2001 Dec;29(12):2239-44. doi: 10.1097/00003246-200112000-00001.
- Background: PubMed 9154884Sirvent JM, Torres A, El-Ebiary M, Castro P, de Batlle J, Bonet A. Protective effect of intravenously administered cefuroxime against nosocomial pneumonia in patients with structural coma. Am J Respir Crit Care Med. 1997 May;155(5):1729-34. doi: 10.1164/ajrccm.155.5.9154884.
- Background: PubMed 23715136Valles J, Peredo R, Burgueno MJ, Rodrigues de Freitas AP, Millan S, Espasa M, Martin-Loeches I, Ferrer R, Suarez D, Artigas A. Efficacy of single-dose antibiotic against early-onset pneumonia in comatose patients who are ventilated. Chest. 2013 May;143(5):1219-1225. doi: 10.1378/chest.12-1361.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Brandon Oto study director
UConn Health, Adult Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone, Amoxicillin clavulanic acid and Cefepime in people with Aspiration and Aspiration Pneumonia, run by UConn Health at 1 site in United States.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 Dec 2025. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU-free Days (time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first). 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 NCT05079620, which also lists 12 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 30 Dec 2025.