Bacteraemia Caused by Gram-Negative BacteriaPIRATENCT03101072
Antibiotic Durations for Gram-negative Bacteremia
A study testing "Fixed long" antibiotic course of 14 days, "Fixed short" antibiotic course of 7 days and "Individualized duration" of antibiotic therapy in people with Bacteraemia Caused by Gram-Negative Bacteria, run by University of Geneva, Switzerland at 3 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteraemia Caused by Gram-Negative Bacteria
- What is being tested?
- "Fixed long" antibiotic course of 14 days, "Fixed short" antibiotic course of 7 days and "Individualized duration" of antibiotic therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 27 Apr 2017to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Presence of Gram-negative bacteria in at least one blood culture bottle
- Treatment with a microbiologically efficacious antibiotic
Who cannot join
- Immunosuppression (including HIV infection with CD4 cell count ≤500/µl, hematopoietic stem-cell transplantation in the first month after transplantation and at any time before engraftment, neutropenia in the 48 hours prior to randomization, receipt of high-dose steroids [>40 mg prednisone or its equivalent] daily for > 2 weeks) in the two weeks prior to randomization
- GNB due to the following complicated infections:
- Endocarditis or other endovascular infection without a removable focus
- Necrotizing fasciitis
- Osteomyelitis or septic arthritis
- Confirmed prostatitis
Show all 11Show fewer
- Undrainable abscess or other unresolved sources requiring surgical intervention (e.g., cholecystitis) at the time of enrollment
- Central nervous system infections
- Empyema
- GNB due to non-fermenting bacilli (Acinetobacter spp., Burkholderia spp., Pseudomonas spp.), Brucella spp., Fusobacterium spp., or polymicrobial growth with Gram-positive organisms
- Fever (≥38º C) or hemodynamic instability in the 24h prior to recruitment
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Geneva University Hospitals
Geneva, 1205
Lausanne University Hospital
Lausanne, Canton of Vaud
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen
About this study
Official title: The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized Controlled Trial for Decreasing Over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia
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.
Read the detailed description
Antibiotic resistance continues to grow and is now considered to be one of the most serious global threats of the 21st century. The key driver of resistance is antibiotic overuse; long antibiotic courses select for resistance among the trillions of bacteria hosted by the human body. There is as yet no evidence from randomized studies on its optimal duration of antibiotic therapy. Traditionally, guidelines have somewhat arbitrarily recommended long courses of two weeks, even though patients with no structural complications may recover after only five days of therapy. Evidence is mounting that longer courses leave patients with multi-resistant organisms. Indeed, given rising concerns over resistance, many physicians have reduced antibiotic durations for GNB to 7 days with no apparent untoward consequences.
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. Patients will be followed through day 90; secondary outcomes will include the incidence of clinical failure on days 60 and 90, the total number of antibiotic days, the incidence of antibiotic-related adverse events (including Clostridium difficile infection), the emergence of bacterial resistance, length of hospital stay. Cost-effectiveness/health-economic analyses will also be performed.
- Being tested
- "Fixed long" antibiotic course of 14 days, "Fixed short" antibiotic course of 7 days, "Individualized duration" of antibiotic therapy
- Keywords
- Gram-negative bacteremia, antibiotic durations, point-of-care randomization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Fixed long" antibiotic course of 14 daysOther
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.)
"Fixed short" antibiotic course of 7 daysOther
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.)
"Individualized duration" of antibiotic therapyOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| "Fixed long" antibiotic course | Active comparator | Patients randomized to this group will receive a "fixed long" antibiotic course of 14 days. Receives: Other: "Fixed long" antibiotic course of 14 days |
| "Fixed short" antibiotic course | Experimental | Patients randomized to this group will receive a "fixed short" antibiotic course of 7 days. Receives: Other: "Fixed short" antibiotic course of 7 days |
| "Individualized" antibiotic course | Experimental | "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% Receives: Other: "Individualized duration" of antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 30 (with day 1 being the first day of microbiologically efficacious antibiotic therapy)
Secondary outcomes (5)
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
Measured: day 60
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
Measured: day 90
Incidence of all-cause mortality in all arms
incidence of all-cause mortality
Measured: day 90
Incidence of Clostridium difficile infection in all arms
incidence of symptomatic C. difficile infection in all arms
Measured: day 90
Incidence of emergence of resistance to the study antibiotic in all arms
The incidence of emergence of resistance in micro-organisms recovered in clinical specimens (whether colonizers or etiologic agents of the gram-negative bacteremia) in all arms
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start27 Apr 2017
- Primary completion11 Jun 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacteraemia Caused by Gram-Negative BacteriaStudies 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
- With day 1 defined as the first day of appropriate (microbiologically efficacious) antibacterial therapy, patients will be randomized 1:1:1 on day 5 (±1) to one of the following three arms: * "Fixed long" antibiotic course of 14 days (control arm) * "Fixed short" antibiotic course of 7 days (first intervention arm) * "Individualized" antibiotic course (second intervention arm): • 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% 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Cantonal Hospital of St. Gallen
- Responsible party
- Principal investigator, Angela HUTTNER, University of Geneva, Switzerland
- Investigators
- Angela Huttner, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101072
- Sponsor's protocol ID
- 2017-00108
- Other IDs
- 2017
- Acronym
- PIRATE
- Status last verified
- Nov 2019
- First submitted
- 29 Mar 2017
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: (There is no plan to share IPD.)
Publications
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.
PubMed 32484534Huttner 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.
PubMed 28710229
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PIRATE PROJECT: a Point-of-care, Informatics-based Randomized Controlled Trial for Decreasing Over-utilization of Antibiotic ThErapy in Gram-negative Bacteremia
- ClinicalTrials.gov ID
- NCT03101072
- Acronym / sponsor ID
- PIRATE / 2017-00108
- Keywords
- Gram-negative bacteremia, antibiotic durations, point-of-care randomization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Cantonal Hospital of St. Gallen
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 4 Apr 2017 (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.
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.
Detailed description
Antibiotic resistance continues to grow and is now considered to be one of the most serious global threats of the 21st century. The key driver of resistance is antibiotic overuse; long antibiotic courses select for resistance among the trillions of bacteria hosted by the human body. There is as yet no evidence from randomized studies on its optimal duration of antibiotic therapy. Traditionally, guidelines have somewhat arbitrarily recommended long courses of two weeks, even though patients with no structural complications may recover after only five days of therapy. Evidence is mounting that longer courses leave patients with multi-resistant organisms. Indeed, given rising concerns over resistance, many physicians have reduced antibiotic durations for GNB to 7 days with no apparent untoward consequences.
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. Patients will be followed through day 90; secondary outcomes will include the incidence of clinical failure on days 60 and 90, the total number of antibiotic days, the incidence of antibiotic-related adverse events (including Clostridium difficile infection), the emergence of bacterial resistance, length of hospital stay. Cost-effectiveness/health-economic analyses will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- With day 1 defined as the first day of appropriate (microbiologically efficacious) antibacterial therapy, patients will be randomized 1:1:1 on day 5 (±1) to one of the following three arms: * "Fixed long" antibiotic course of 14 days (control arm) * "Fixed short" antibiotic course of 7 days (first intervention arm) * "Individualized" antibiotic course (second intervention arm): • 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% 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.
| Arm | Type | Receives |
|---|---|---|
| "Fixed long" antibiotic course | Active comparator | Other: "Fixed long" antibiotic course of 14 daysPatients randomized to this group will receive a "fixed long" antibiotic course of 14 days. |
| "Fixed short" antibiotic course | Experimental | Other: "Fixed short" antibiotic course of 7 daysPatients randomized to this group will receive a "fixed short" antibiotic course of 7 days. |
| "Individualized" antibiotic course | Experimental | Other: "Individualized duration" of antibiotic therapy"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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Presence of Gram-negative bacteria in at least one blood culture bottle
- Treatment with a microbiologically efficacious antibiotic
Key exclusion criteria (11 listed)
- Immunosuppression (including HIV infection with CD4 cell count ≤500/µl, hematopoietic stem-cell transplantation in the first month after transplantation and at any time before engraftment, neutropenia in the 48 hours prior to randomization, receipt of high-dose steroids [>40 mg prednisone or its equivalent] daily for > 2 weeks) in the two weeks prior to randomization
- GNB due to the following complicated infections:
- GNB due to non-fermenting bacilli (Acinetobacter spp., Burkholderia spp., Pseudomonas spp.), Brucella spp., Fusobacterium spp., or polymicrobial growth with Gram-positive organisms
- Fever (≥38º C) or hemodynamic instability in the 24h prior to recruitment
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 |
|---|---|---|
| "Fixed long" antibiotic course of 14 daysOnly 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.) | Other | "Fixed long" antibiotic course |
| "Fixed short" antibiotic course of 7 daysOnly 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.) | Other | "Fixed short" antibiotic course |
| "Individualized duration" of antibiotic therapyOnly 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.) | Other | "Individualized" antibiotic course |
Primary outcome
Incidence of clinical failure in all arms
Time frame: day 30 (with day 1 being the first day of microbiologically efficacious antibiotic therapy)
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
5 secondary outcomes
Incidence of clinical failure in all arms
Time frame: day 60
Incidence of clinical failure in all arms
Time frame: day 90
Incidence of all-cause mortality in all arms
Time frame: day 90
Incidence of Clostridium difficile infection in all arms
Time frame: day 90
Incidence of emergence of resistance to the study antibiotic in all arms
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Derived from this study: PubMed 32484534von 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.
- Derived from this study: PubMed 28710229Huttner 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.
- Individual participant dataSharing planned: No. (There is no plan to share IPD.)
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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.
Angela Huttner, MD principal investigator
University of Geneva, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Fixed long" antibiotic course of 14 days, "Fixed short" antibiotic course of 7 days and "Individualized duration" of antibiotic therapy in people with Bacteraemia Caused by Gram-Negative Bacteria, run by University of Geneva, Switzerland at 3 sites in Switzerland.
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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of clinical failure in all arms (time frame: day 30 (with day 1 being the first day of microbiologically efficacious antibiotic therapy)). 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 NCT03101072, which also lists 2 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 19 Nov 2019.