Postoperative PeritonitisPhase 3DURAPOPNCT01311765
Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU
A Phase 3 study testing Duration of antibiotic therapy limited to 8 days in people with Postoperative Peritonitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Peritonitis
- What is being tested?
- Duration of antibiotic therapy limited to 8 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Nov 2015
- Phase
- Phase 3
- 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
- The eligible patients have to fulfill all the following criteria
- patients admitted in intensive care unit
- in the 24 hours following surgery for postoperative intra-abdominal infection (defined as gross pus or purulent effusion within the peritoneal cavity or in one or several collections). Postoperative infection will be defined as an infection observed in a delay of 60 days following a procedure (endoscopy, surgery (abdominal, urologic, gynecologic or vascular surgery or any surgery performed in the peritoneal or retroperitoneal space) or interventional radiology)
- having peroperative microbiologic samples collected
- receiving an empiric antibiotic therapy initiated within the first 24 hours after completion of surgery
- with a written informed consent from the patient or the relative or the legal representative or with an emergency consent
Show all 26Show fewer
- Non-inclusion criteria :
- Patients with one of the following criteria are eligible for the study :
- age<18
- pregnancy
- Duration of stay following inclusion <72 hours
- neutropenia (PMN<500/mm3) due to chemotherapy or hematological disease
- AIDS stage C
- Immunosuppressive therapy or prolonged steroid therapy (≥0.5 mg/kg/d of prednisone or equivalent >1 month
- Bowel perforation following endoscopy treated in a delay <6 hours after injury
- Uterine perforation following a surgical procedure treated in a delay <6 hours after injury
- Moribund patient (SAPS II score >65 within 12 hours preceding inclusion)
- Limitation of treatment previously decided
- Surgery considered as non curative by the surgeon
- Patient included in another clinical trial evaluating an antimicrobial agent
- Secondary exclusion criteria:
- Among the eligible patients, those who have one of the following criteria will be excluded
- Negative culture of the peritoneal fluid
- Peritoneal culture exclusively fungal
- Inadequate empiric antibiotic therapy (not targeting all the microorganisms cultured from peritoneal or blood cultures) within 24 hours after surgery
- Death between D1 and D8
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study
The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment.
Read the detailed description
This is a prospective randomized study involving 25 centers. Our goal is to demonstrate in the course of postoperative peritonitis that a short antibiotic therapy (8 days) compared to conventional antibiotic treatment (15 days) decreases the duration of exposure to antibiotics over a 28 days period . Patients admitted in ICU, operated for postoperative peritonitis and receiving an adequate antibiotic therapy will be identified and after informed consent is obtained will be randomized to receive a short course of antibiotic therapy (8 days) or a long course of antibiotic therapy (15 days). The primary endpoint is the number of antibiotic-free days at D28 after inclusion (analysis of superiority) . Secondary endpoints include mortality at D45 after inclusion (analysis of equivalence), the occurrence of relapse of infection, success rate of clinically and microbiologically evaluable patients, and emergence of multidrug resistant microorganisms in clinical isolates or hygiene samples. Patient data through day 45 following the initial intervention or until hospital discharge will be tracked.
- Conditions
- Postoperative Peritonitis
- Being tested
- Duration of antibiotic therapy limited to 8 days
- Keywords
- Postoperative peritonitis, Intra-abdominal infection, Surgery, Laparotomy, Nosocomial infection, Antibiotic therapy, Duration of treatment, Multidrug resistant bacteria
- Medical subject headings
- Intraabdominal Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of antibiotic therapy limited to 8 daysOther
Initiation of adequate empiric antibiotics for postoperative peritonitis within 24 hours after surgery and up to 8 days. At randomisation performed on day 8, the patients assigned to the 8-day group (short-course group) stop their treatment
| Study group | Role | What they receive |
|---|---|---|
| 8 day-antibiotherapy | Active comparator | Duration of antibiotic therapy limited to 8 days: Antibiotics received for up to 8 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit Receives: Other: Duration of antibiotic therapy limited to 8 days |
| 15 day-antibiotherapy | No intervention | Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of antibiotic-free days at D28 after inclusion
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
Measured: 28 days
Secondary outcomes (12)
Mortality at D45 after inclusion
Mortality at D45 after inclusion (analysis of equivalence)
Measured: 45 days
Duration of ICU and hospital stay
Duration of ICU and hospital stay
Measured: 45 days
Changes in SOFA score
Changes in SOFA score
Measured: 8 days
Number of days alive without organ failure
Number of days alive without organ failure
Measured: 28 days
Failure rate for clinically evaluable patients
Failure rate for clinically evaluable patients
Measured: 28 days
Failure rate for microbiologically evaluable patients
Failure rate for microbiologically evaluable patients
Measured: 28 days
Rate of relapse within 45 days
Rate of relapse within 45 days
Measured: 45 days
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Measured: ICU discharge
Total cost of antibiotic agents
Total cost of antibiotic agents
Measured: 28 days
Evolution of procalcitonin plasma concentration
Evolution of procalcitonin plasma concentration
Measured: 15 days
Rate of death within 45 days in specific subpopulations (elderly patients >80 years ; morbidly obese patients BMI>25kg/m2 ; severe infection with SAPSII score >40 ;peritoneal infection involving pseudomonas or enterococci ; bacteriemic infections)
Rate of death within 45 days in specific subpopulations (elderly patients >80 years ; morbidly obese patients BMI>25kg/m2 ; severe infection with SAPSII score >40 ;peritoneal infection involving pseudomonas or enterococci ; bacteriemic infections)
Measured: 45 days
Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PeritonitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Montravers, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311765
- Sponsor's protocol ID
- P081248
- Acronym
- DURAPOP
- Status last verified
- Jul 2015
- First submitted
- 22 Feb 2011
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Montravers P, Tubach F, Lescot T, Veber B, Esposito-Farese M, Seguin P, Paugam C, Lepape A, Meistelman C, Cousson J, Tesniere A, Plantefeve G, Blasco G, Asehnoune K, Jaber S, Lasocki S, Dupont H; DURAPOP Trial Group. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26.
PubMed 29484469
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study
- ClinicalTrials.gov ID
- NCT01311765
- Acronym / sponsor ID
- DURAPOP / P081248
- Conditions
- Postoperative Peritonitis
- Keywords
- Postoperative peritonitis, Intra-abdominal infection, Surgery, Laparotomy, Nosocomial infection, Antibiotic therapy, Duration of treatment, Multidrug resistant bacteria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Mar 2011 (estimated)
- 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.
The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment.
Detailed description
This is a prospective randomized study involving 25 centers. Our goal is to demonstrate in the course of postoperative peritonitis that a short antibiotic therapy (8 days) compared to conventional antibiotic treatment (15 days) decreases the duration of exposure to antibiotics over a 28 days period . Patients admitted in ICU, operated for postoperative peritonitis and receiving an adequate antibiotic therapy will be identified and after informed consent is obtained will be randomized to receive a short course of antibiotic therapy (8 days) or a long course of antibiotic therapy (15 days). The primary endpoint is the number of antibiotic-free days at D28 after inclusion (analysis of superiority) . Secondary endpoints include mortality at D45 after inclusion (analysis of equivalence), the occurrence of relapse of infection, success rate of clinically and microbiologically evaluable patients, and emergence of multidrug resistant microorganisms in clinical isolates or hygiene samples. Patient data through day 45 following the initial intervention or until hospital discharge will be tracked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 day-antibiotherapy | Active comparator | Other: Duration of antibiotic therapy limited to 8 daysDuration of antibiotic therapy limited to 8 days: Antibiotics received for up to 8 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit |
| 15 day-antibiotherapy | No intervention | –Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- The eligible patients have to fulfill all the following criteria
- patients admitted in intensive care unit
- in the 24 hours following surgery for postoperative intra-abdominal infection (defined as gross pus or purulent effusion within the peritoneal cavity or in one or several collections). Postoperative infection will be defined as an infection observed in a delay of 60 days following a procedure (endoscopy, surgery (abdominal, urologic, gynecologic or vascular surgery or any surgery performed in the peritoneal or retroperitoneal space) or interventional radiology)
- having peroperative microbiologic samples collected
- receiving an empiric antibiotic therapy initiated within the first 24 hours after completion of surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Duration of antibiotic therapy limited to 8 daysInitiation of adequate empiric antibiotics for postoperative peritonitis within 24 hours after surgery and up to 8 days. At randomisation performed on day 8, the patients assigned to the 8-day group (short-course group) stop their treatment | Other | 8 day-antibiotherapy |
Primary outcome
The number of antibiotic-free days at D28 after inclusion
Time frame: 28 days
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
12 secondary outcomes
Mortality at D45 after inclusion
Time frame: 45 days
Duration of ICU and hospital stay
Time frame: 45 days
Changes in SOFA score
Time frame: 8 days
Number of days alive without organ failure
Time frame: 28 days
Failure rate for clinically evaluable patients
Time frame: 28 days
Failure rate for microbiologically evaluable patients
Time frame: 28 days
Rate of relapse within 45 days
Time frame: 45 days
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Time frame: ICU discharge
Total cost of antibiotic agents
Time frame: 28 days
Evolution of procalcitonin plasma concentration
Time frame: 15 days
Rate of death within 45 days in specific subpopulations (elderly patients >80 years ; morbidly obese patients BMI>25kg/m2 ; severe infection with SAPSII score >40 ;peritoneal infection involving pseudomonas or enterococci ; bacteriemic infections)
Time frame: 45 days
Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Time frame: Hospital discharge
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 9 Dec 2015.
- Derived from this study: PubMed 29484469Montravers P, Tubach F, Lescot T, Veber B, Esposito-Farese M, Seguin P, Paugam C, Lepape A, Meistelman C, Cousson J, Tesniere A, Plantefeve G, Blasco G, Asehnoune K, Jaber S, Lasocki S, Dupont H; DURAPOP Trial Group. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26.
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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.
Philippe Montravers, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duration of antibiotic therapy limited to 8 days in people with Postoperative Peritonitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 26 inclusion and 0 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 9 Dec 2015. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of antibiotic-free days at D28 after inclusion (time frame: 28 days). 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 NCT01311765, which also lists 1 linked publication.
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 9 Dec 2015.