PIRATE
The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized Controlled Trial for Decreasing Over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia
Sponsor study identifier
Secondary identifiers
NIH
interventional
504
1 country
3
Study Start
April 27, 2017
Actual (reported)Primary Completion
June 11, 2019
Actual (reported)Study Completion
August 26, 2019
Actual (reported)Gram-negative bacteremia (GNB) is a frequent hospital \& community-acquired infection, yet there is as yet no evidence from randomized studies on the optimal duration of antibiotic therapy. This point-of-care, multicenter randomized controlled non-inferiority trial will randomize 500 patients with GNB on day 5 of appropriate antibiotic therapy to either (1) a total of 7 days of antibiotic therapy, (2) a total of 14 days of antibiotic therapy, or (3) an individualized duration of antibiotic therapy (guided by the patient's clinical course \& C-reactive protein levels). The primary outcome is the incidence of clinical failure at day 30.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 26, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2017
Actual (reported)April 4, 2017
Actual (reported)April 27, 2017
Actual (reported)June 11, 2019
Actual (reported)August 26, 2019
Actual (reported)Incidence of clinical failure in all arms
Clinical failure is defined by the presence of at least one of the following: * Relapse: a recurrent bacteremia due to the same bacterium occurring from the day of treatment cessation and until day 30 * Local suppurative complication that was not present/apparent at infection onset (e.g., renal abscess in pyelonephritis, empyema in pneumonia) * Distant complications of the initial infection, defined by growth of the same bacterium causing the initial bacteremia (as determined by antibiotic susceptibility profiling) * The restarting of Gram-negative-directed antibiotic therapy after its initial discontinuation due to clinical worsening suspected to be due to the initial infecting organism and for which there is no alternate diagnosis/pathogen suspected * Death due to any cause through day 30
day 30 (with day 1 being the first day of microbiologically efficacious antibiotic therapy)
Incidence of clinical failure in all arms
day 60
Incidence of clinical failure in all arms
day 90
Incidence of all-cause mortality in all arms
day 90
Incidence of Clostridium difficile infection in all arms
day 90
Incidence of emergence of resistance to the study antibiotic in all arms
day 90
Patients randomized to this group will receive a "fixed long" antibiotic course of 14 days.
Patients randomized to this group will receive a "fixed short" antibiotic course of 7 days.
"Individualized" antibiotic course: starting on day 5, therapy will be discontinued after the patient has been afebrile for 48 hours and the CRP level has decreased from its peak by at least 75%
Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)
Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
Geneva University Hospitals
Geneva, 1205, Switzerland
von Dach E, Albrich WC, Brunel AS, Prendki V, Cuvelier C, Flury D, Gayet-Ageron A, Huttner B, Kohler P, Lemmenmeier E, McCallin S, Rossel A, Harbarth S, Kaiser L, Bochud PY, Huttner A. Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial. JAMA. 2020 Jun 2;323(21):2160-2169. doi: 10.1001/jama.2020.6348.
Huttner A, Albrich WC, Bochud PY, Gayet-Ageron A, Rossel A, Dach EV, Harbarth S, Kaiser L. PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia. BMJ Open. 2017 Jul 13;7(7):e017996. doi: 10.1136/bmjopen-2017-017996.
Angela Huttner, MD
University of Geneva, Switzerland
504 participants (actual enrollment reported by the registry).
Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Submitted
March 29, 2017
First Posted
April 4, 2017
Study Start
April 27, 2017
Actual (reported)Primary Completion
June 11, 2019
Actual (reported)Study Completion
August 26, 2019
Actual (reported)Last Updated
November 19, 2019
Record last verified: 2019-11
(There is no plan to share IPD.)
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Source: ClinicalTrials.gov.
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