Back to resultsDuration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU (DURAPOP)
Primary Purpose
Postoperative Peritonitis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Duration of antibiotic therapy limited to 8 days
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Peritonitis focused on measuring Postoperative peritonitis, Intra-abdominal infection, Surgery, Laparotomy, Nosocomial infection, Antibiotic therapy, Duration of treatment, Multidrug resistant bacteria
Eligibility Criteria
Inclusion Criteria:
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
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
Sites / Locations
- Hôpital Bichat
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
8 day-antibiotherapy
15 day-antibiotherapy
Arm Description
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
Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations
Outcomes
Primary Outcome Measures
The number of antibiotic-free days at D28 after inclusion
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
Secondary Outcome Measures
Mortality at D45 after inclusion
Mortality at D45 after inclusion (analysis of equivalence)
Duration of ICU and hospital stay
Duration of ICU and hospital stay
Changes in SOFA score
Changes in SOFA score
Number of days alive without organ failure
Number of days alive without organ failure
Failure rate for clinically evaluable patients
Failure rate for clinically evaluable patients
Failure rate for microbiologically evaluable patients
Failure rate for microbiologically evaluable patients
Rate of relapse within 45 days
Rate of relapse within 45 days
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Total cost of antibiotic agents
Total cost of antibiotic agents
Evolution of procalcitonin plasma concentration
Evolution of procalcitonin plasma concentration
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)
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
Full Information
NCT ID
NCT01311765
First Posted
February 22, 2011
Last Updated
December 8, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01311765
Brief Title
Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU
Acronym
DURAPOP
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Peritonitis
Keywords
Postoperative peritonitis, Intra-abdominal infection, Surgery, Laparotomy, Nosocomial infection, Antibiotic therapy, Duration of treatment, Multidrug resistant bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8 day-antibiotherapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
15 day-antibiotherapy
Arm Type
No Intervention
Arm Description
Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations
Intervention Type
Other
Intervention Name(s)
Duration of antibiotic therapy limited to 8 days
Intervention Description
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
Primary Outcome Measure Information:
Title
The number of antibiotic-free days at D28 after inclusion
Description
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mortality at D45 after inclusion
Description
Mortality at D45 after inclusion (analysis of equivalence)
Time Frame
45 days
Title
Duration of ICU and hospital stay
Description
Duration of ICU and hospital stay
Time Frame
45 days
Title
Changes in SOFA score
Description
Changes in SOFA score
Time Frame
8 days
Title
Number of days alive without organ failure
Description
Number of days alive without organ failure
Time Frame
28 days
Title
Failure rate for clinically evaluable patients
Description
Failure rate for clinically evaluable patients
Time Frame
28 days
Title
Failure rate for microbiologically evaluable patients
Description
Failure rate for microbiologically evaluable patients
Time Frame
28 days
Title
Rate of relapse within 45 days
Description
Rate of relapse within 45 days
Time Frame
45 days
Title
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Description
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Time Frame
ICU discharge
Title
Total cost of antibiotic agents
Description
Total cost of antibiotic agents
Time Frame
28 days
Title
Evolution of procalcitonin plasma concentration
Description
Evolution of procalcitonin plasma concentration
Time Frame
15 days
Title
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)
Description
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
Title
Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Description
Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Time Frame
Hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Montravers, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29484469
Citation
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.
Results Reference
derived
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Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU
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