Lower Respiratory Tract Infection (LRTI)ProACTNCT02130986
Procalcitonin Antibiotic Consensus Trial (ProACT)
A study testing Procalcitonin level, Results of procalcitonin (PCT) level to treating clinician and Provide procalcitonin guideline to treating clinician in people with Lower Respiratory Tract Infection (LRTI), run by University of Pittsburgh at 13 sites in United States.
Trial summary
The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infection (LRTI)
- What is being tested?
- Procalcitonin level, Results of procalcitonin (PCT) level to treating clinician and Provide procalcitonin guideline to treating clinician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,664 participants
- Where
- 13 sitesUnited States
- Study dates
- 3 Nov 2014to 21 Jul 2017
- Phase
- Interventional
- 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
- ≥ 18 years old
- A primary clinical diagnosis in the ED of acute LRTI (< 28 days duration)
- Clinician willing to consider procalcitonin in antibiotic decision-making
Who cannot join
- Systemic antibiotics before ED presentation (All prophylactic antibiotic regimens, OR received >1 dose within 72 hours prior to ED presentation)
- Current vasopressor use
- Mechanical ventilation (via endotracheal tube)
- Known severe immunosuppression
- Accompanying non-respiratory infections
- Known lung abscess or empyema
Show all 11Show fewer
- Chronic dialysis
- Metastatic cancer
- Surgery in the past 7 days (excluding minor surgery such as skin biopsy)
- Incarcerated or homeless
- Enrolled in ProACT in the past 30 days
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Maryland/Baltimore
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The Ohio State University, College of Medicine
Columbus, Ohio, 43210
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, 48201
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
Penn State Hershey College of Medicine; Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Norwalk Hospital
Norwalk, Connecticut, 06856
University of California at Irvine Medical Center
Orange, California, 92868
Maricopa Medical Center
Phoenix, Arizona, 85008
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
About this study
The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI).
Read the detailed description
There is a need for improved decision-making for antibiotic prescription in acute suspected infection. Infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. However, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance.
Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. This approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy.
Procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. Lower respiratory tract infection (LRTI) is an ideal trial population. LRTI accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.However, key questions of generalizability and safety preclude widespread application.
- Conditions
- Lower Respiratory Tract Infection (LRTI)
- Being tested
- Procalcitonin level, Results of procalcitonin (PCT) level to treating clinician, Provide procalcitonin guideline to treating clinician, Telephone Visit
- Keywords
- procalcitonin (PCT), lower respiratory tract infection (LRTI), antibiotic exposure, antibiotic decision making, community acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD) exacerbation, acute asthma exacerbation, acute bronchitis, procalcitonin guideline
- Medical subject headings
- Community-Acquired Pneumonia, Pulmonary Disease, Chronic Obstructive, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin levelOther
Also called PCT level
A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.
Results of procalcitonin (PCT) level to treating clinicianOther
In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result.
Provide procalcitonin guideline to treating clinicianOther
Procalcitonin antibiotic guideline --
Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation
< 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1)
0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1)
> 0.25 - 0.5 -- Likely -- Antibiotics recommended(2)
> 0.5 -- Very likely -- Antibiotics strongly recommended(2)
- Initial antibiotics can be considered for critical illness, Legionella pneumophilia. Procalcitonin should be evaluated in context with all findings and the total clinical status; clinical judgment always necessary.
- For outpatients, antibiotic duration based on level (> 0.25-0.5 ug/L:3 days; > 0.5-1.0 ug/L:5 days; >1.0 ug/L:7 days). Physician follow-up is recommended.
Telephone VisitOther
We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin (PCT) group | Experimental | Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30 Receives: Other: Procalcitonin level; Other: Results of procalcitonin (PCT) level to treating clinician; Other: Provide procalcitonin guideline to treating clinician; Other: Telephone Visit |
| Usual Care group | Active comparator | Telephone Visit at Day 15 and Day 30 Receives: Other: Telephone Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Antibiotic Exposure Days
Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.
Measured: 30 days
Number of Participants With Any Adverse Outcome
Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI).
Number is based on the number of participants that experienced any adverse outcome.
Measured: 30 days
Secondary outcomes (1)
Antibiotic Prescription in Emergency Department(ED)
Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED.
Measured: While in the ED or before ED discharge (majority patients < 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start3 Nov 2014
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
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 (23)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract Infection (LRTI)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,664 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), BioMérieux
- Responsible party
- Principal investigator, David T. Huang, MD, MPH, University of Pittsburgh
- Investigators
- David T Huang, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130986
- Sponsor's protocol ID
- 1R01GM101197
- Other IDs
- 1R01GM101197
- Acronym
- ProACT
- Status last verified
- Jan 2019
- First submitted
- 1 May 2014
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Meisner M. Biomarkers of sepsis: clinically useful? Curr Opin Crit Care. 2005 Oct;11(5):473-80. doi: 10.1097/01.ccx.0000176694.92883.ce.
PubMed 16175035Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections--hope for hype? Swiss Med Wkly. 2009 Jun 13;139(23-24):318-26. doi: 10.4414/smw.2009.12584.
PubMed 19529989Muller B, White JC, Nylen ES, Snider RH, Becker KL, Habener JF. Ubiquitous expression of the calcitonin-i gene in multiple tissues in response to sepsis. J Clin Endocrinol Metab. 2001 Jan;86(1):396-404. doi: 10.1210/jcem.86.1.7089.
PubMed 11232031Nylen E, Muller B, Becker KL, Snider R. The future diagnostic role of procalcitonin levels: the need for improved sensitivity. Clin Infect Dis. 2003 Mar 15;36(6):823-4; author reply 826-7. doi: 10.1086/368088. No abstract available.
PubMed 12627371Uzzan B, Cohen R, Nicolas P, Cucherat M, Perret GY. Procalcitonin as a diagnostic test for sepsis in critically ill adults and after surgery or trauma: a systematic review and meta-analysis. Crit Care Med. 2006 Jul;34(7):1996-2003. doi: 10.1097/01.CCM.0000226413.54364.36.
PubMed 16715031Jones AE, Fiechtl JF, Brown MD, Ballew JJ, Kline JA. Procalcitonin test in the diagnosis of bacteremia: a meta-analysis. Ann Emerg Med. 2007 Jul;50(1):34-41. doi: 10.1016/j.annemergmed.2006.10.020. Epub 2006 Dec 11.
PubMed 17161501Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2.
PubMed 15307030Stolz D, Christ-Crain M, Gencay MM, Bingisser R, Huber PR, Muller B, Tamm M. Diagnostic value of signs, symptoms and laboratory values in lower respiratory tract infection. Swiss Med Wkly. 2006 Jul 8;136(27-28):434-40. doi: 10.4414/smw.2006.11271.
PubMed 16862463Hirakata Y, Yanagihara K, Kurihara S, Izumikawa K, Seki M, Miyazaki Y, Kohno S. Comparison of usefulness of plasma procalcitonin and C-reactive protein measurements for estimation of severity in adults with community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Jun;61(2):170-4. doi: 10.1016/j.diagmicrobio.2008.01.014. Epub 2008 Mar 7.
PubMed 18329217Prieto B, Llorente E, Gonzalez-Pinto I, Alvarez FV. Plasma procalcitonin measured by time-resolved amplified cryptate emission (TRACE) in liver transplant patients. A prognosis marker of early infectious and non-infectious postoperative complications. Clin Chem Lab Med. 2008;46(5):660-6. doi: 10.1515/cclm.2008.123.
PubMed 18839468Prat C, Sancho JM, Dominguez J, Xicoy B, Gimenez M, Ferra C, Blanco S, Lacoma A, Ribera JM, Ausina V. Evaluation of procalcitonin, neopterin, C-reactive protein, IL-6 and IL-8 as a diagnostic marker of infection in patients with febrile neutropenia. Leuk Lymphoma. 2008 Sep;49(9):1752-61. doi: 10.1080/10428190802258956.
PubMed 18661397Charles PE, Kus E, Aho S, Prin S, Doise JM, Olsson NO, Blettery B, Quenot JP. Serum procalcitonin for the early recognition of nosocomial infection in the critically ill patients: a preliminary report. BMC Infect Dis. 2009 Apr 22;9:49. doi: 10.1186/1471-2334-9-49.
PubMed 19386110Huang DT, Weissfeld LA, Kellum JA, Yealy DM, Kong L, Martino M, Angus DC; GenIMS Investigators. Risk prediction with procalcitonin and clinical rules in community-acquired pneumonia. Ann Emerg Med. 2008 Jul;52(1):48-58.e2. doi: 10.1016/j.annemergmed.2008.01.003. Epub 2008 Mar 17.
PubMed 18342993Muller B, Harbarth S, Stolz D, Bingisser R, Mueller C, Leuppi J, Nusbaumer C, Tamm M, Christ-Crain M. Diagnostic and prognostic accuracy of clinical and laboratory parameters in community-acquired pneumonia. BMC Infect Dis. 2007 Mar 2;7:10. doi: 10.1186/1471-2334-7-10.
PubMed 17335562Cuquemelle E, Soulis F, Villers D, Roche-Campo F, Ara Somohano C, Fartoukh M, Kouatchet A, Mourvillier B, Dellamonica J, Picard W, Schmidt M, Boulain T, Brun-Buisson C; A/H1N1 REVA-SRLF Study Group. Can procalcitonin help identify associated bacterial infection in patients with severe influenza pneumonia? A multicentre study. Intensive Care Med. 2011 May;37(5):796-800. doi: 10.1007/s00134-011-2189-1. Epub 2011 Mar 3.
PubMed 21369807
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Antibiotic Consensus Trial (ProACT)
- ClinicalTrials.gov ID
- NCT02130986
- Acronym / sponsor ID
- ProACT / 1R01GM101197
- Conditions
- Lower Respiratory Tract Infection (LRTI)
- Keywords
- procalcitonin (PCT), lower respiratory tract infection (LRTI), antibiotic exposure, antibiotic decision making, community acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD) exacerbation, acute asthma exacerbation, acute bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,664 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), BioMérieux
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Posted 15 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI).
Detailed description
There is a need for improved decision-making for antibiotic prescription in acute suspected infection. Infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. However, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance.
Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. This approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy.
Procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. Lower respiratory tract infection (LRTI) is an ideal trial population. LRTI accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.However, key questions of generalizability and safety preclude widespread application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin (PCT) group | Experimental | Other: Procalcitonin level, Other: Results of procalcitonin (PCT) level to treating clinician, Other: Provide procalcitonin guideline to treating clinician, Other: Telephone VisitProcalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30 |
| Usual Care group | Active comparator | Other: Telephone VisitTelephone Visit at Day 15 and Day 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- A primary clinical diagnosis in the ED of acute LRTI (< 28 days duration)
- Clinician willing to consider procalcitonin in antibiotic decision-making
Key exclusion criteria (11 listed)
- Systemic antibiotics before ED presentation (All prophylactic antibiotic regimens, OR received >1 dose within 72 hours prior to ED presentation)
- Current vasopressor use
- Mechanical ventilation (via endotracheal tube)
- Known severe immunosuppression
- Accompanying non-respiratory infections
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 |
|---|---|---|
| Procalcitonin levelAlso: PCT levelA procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion. | Other | Procalcitonin (PCT) group |
| Results of procalcitonin (PCT) level to treating clinicianIn the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result. | Other | Procalcitonin (PCT) group |
| Provide procalcitonin guideline to treating clinicianProcalcitonin antibiotic guideline -- Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation < 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1) 0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1) > 0.25 - 0.5 -- Likely -- Antibiotics recommended(2) > 0.5 -- Very likely -- Antibiotics strongly recommended(2) 1. Initial antibiotics can be considered for critical illness, Legionella pneumophilia. Procalcitonin should be evaluated in context with all findings and the total clinical status; clinical judgment always necessary. 2. For outpatients, antibiotic duration based on level (> 0.25-0.5 ug/L:3 days; > 0.5-1.0 ug/L:5 days; >1.0 ug/L:7 days). Physician follow-up is recommended. | Other | Procalcitonin (PCT) group |
| Telephone VisitWe will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30 | Other | Procalcitonin (PCT) group, Usual Care group |
Primary outcome
Total Antibiotic Exposure Days
Time frame: 30 days
Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.
Number of Participants With Any Adverse Outcome
Time frame: 30 days
Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI). Number is based on the number of participants that experienced any adverse outcome.
1 secondary outcome
Antibiotic Prescription in Emergency Department(ED)
Time frame: While in the ED or before ED discharge (majority patients < 1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16175035Meisner M. Biomarkers of sepsis: clinically useful? Curr Opin Crit Care. 2005 Oct;11(5):473-80. doi: 10.1097/01.ccx.0000176694.92883.ce.
- Background: PubMed 19529989Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections--hope for hype? Swiss Med Wkly. 2009 Jun 13;139(23-24):318-26. doi: 10.4414/smw.2009.12584.
- Background: PubMed 11232031Muller B, White JC, Nylen ES, Snider RH, Becker KL, Habener JF. Ubiquitous expression of the calcitonin-i gene in multiple tissues in response to sepsis. J Clin Endocrinol Metab. 2001 Jan;86(1):396-404. doi: 10.1210/jcem.86.1.7089.
- Background: PubMed 12627371Nylen E, Muller B, Becker KL, Snider R. The future diagnostic role of procalcitonin levels: the need for improved sensitivity. Clin Infect Dis. 2003 Mar 15;36(6):823-4; author reply 826-7. doi: 10.1086/368088. No abstract available.
- Background: PubMed 16715031Uzzan B, Cohen R, Nicolas P, Cucherat M, Perret GY. Procalcitonin as a diagnostic test for sepsis in critically ill adults and after surgery or trauma: a systematic review and meta-analysis. Crit Care Med. 2006 Jul;34(7):1996-2003. doi: 10.1097/01.CCM.0000226413.54364.36.
- Background: PubMed 17161501Jones AE, Fiechtl JF, Brown MD, Ballew JJ, Kline JA. Procalcitonin test in the diagnosis of bacteremia: a meta-analysis. Ann Emerg Med. 2007 Jul;50(1):34-41. doi: 10.1016/j.annemergmed.2006.10.020. Epub 2006 Dec 11.
- Background: PubMed 15307030Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2.
- Background: PubMed 16862463Stolz D, Christ-Crain M, Gencay MM, Bingisser R, Huber PR, Muller B, Tamm M. Diagnostic value of signs, symptoms and laboratory values in lower respiratory tract infection. Swiss Med Wkly. 2006 Jul 8;136(27-28):434-40. doi: 10.4414/smw.2006.11271.
- Background: PubMed 18329217Hirakata Y, Yanagihara K, Kurihara S, Izumikawa K, Seki M, Miyazaki Y, Kohno S. Comparison of usefulness of plasma procalcitonin and C-reactive protein measurements for estimation of severity in adults with community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Jun;61(2):170-4. doi: 10.1016/j.diagmicrobio.2008.01.014. Epub 2008 Mar 7.
- Background: PubMed 18839468Prieto B, Llorente E, Gonzalez-Pinto I, Alvarez FV. Plasma procalcitonin measured by time-resolved amplified cryptate emission (TRACE) in liver transplant patients. A prognosis marker of early infectious and non-infectious postoperative complications. Clin Chem Lab Med. 2008;46(5):660-6. doi: 10.1515/cclm.2008.123.
- Background: PubMed 18661397Prat C, Sancho JM, Dominguez J, Xicoy B, Gimenez M, Ferra C, Blanco S, Lacoma A, Ribera JM, Ausina V. Evaluation of procalcitonin, neopterin, C-reactive protein, IL-6 and IL-8 as a diagnostic marker of infection in patients with febrile neutropenia. Leuk Lymphoma. 2008 Sep;49(9):1752-61. doi: 10.1080/10428190802258956.
- Background: PubMed 19386110Charles PE, Kus E, Aho S, Prin S, Doise JM, Olsson NO, Blettery B, Quenot JP. Serum procalcitonin for the early recognition of nosocomial infection in the critically ill patients: a preliminary report. BMC Infect Dis. 2009 Apr 22;9:49. doi: 10.1186/1471-2334-9-49.
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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.
David T Huang, MD MPH principal investigator
University of Pittsburgh
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin level, Results of procalcitonin (PCT) level to treating clinician and Provide procalcitonin guideline to treating clinician in people with Lower Respiratory Tract Infection (LRTI), run by University of Pittsburgh at 13 sites 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 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: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2019). 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?
Total Antibiotic Exposure Days (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT02130986, which also lists 23 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 15 Jan 2019.