Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU (DURAPOP)
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| ClinicalTrials.gov Identifier: NCT01311765 |
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Recruitment Status :
Completed
First Posted : March 10, 2011
Last Update Posted : December 9, 2015
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Peritonitis | Other: Duration of antibiotic therapy limited to 8 days | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 244 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | May 2011 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | November 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 8 day-antibiotherapy
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
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Other: Duration of antibiotic therapy limited to 8 days
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 |
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No Intervention: 15 day-antibiotherapy
Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations
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Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- Mortality at D45 after inclusion [ Time Frame: 45 days ]Mortality at D45 after inclusion (analysis of equivalence)
- Duration of ICU and hospital stay [ Time Frame: 45 days ]Duration of ICU and hospital stay
- Changes in SOFA score [ Time Frame: 8 days ]Changes in SOFA score
- Number of days alive without organ failure [ Time Frame: 28 days ]Number of days alive without organ failure
- Failure rate for clinically evaluable patients [ Time Frame: 28 days ]Failure rate for clinically evaluable patients
- Failure rate for microbiologically evaluable patients [ Time Frame: 28 days ]Failure rate for microbiologically evaluable patients
- Rate of relapse within 45 days [ Time Frame: 45 days ]Rate of relapse within 45 days
- Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples [ Time Frame: ICU discharge ]Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
- Total cost of antibiotic agents [ Time Frame: 28 days ]Total cost of antibiotic agents
- Evolution of procalcitonin plasma concentration [ Time Frame: 15 days ]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) [ Time Frame: 45 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)
- Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration [ Time Frame: Hospital discharge ]Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311765
Locations
| France | |
| Hôpital Bichat | |
| Paris, France, 75018 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Philippe Montravers, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01311765 History of Changes |
| Other Study ID Numbers: |
P081248 |
| First Posted: | March 10, 2011 Key Record Dates |
| Last Update Posted: | December 9, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Postoperative peritonitis Intra-abdominal infection Surgery Laparotomy |
Nosocomial infection Antibiotic therapy Duration of treatment Multidrug resistant bacteria |
Additional relevant MeSH terms:
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Peritonitis Intraabdominal Infections Infection Peritoneal Diseases Digestive System Diseases |
Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |