Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU

Postoperative Peritonitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311765
• Other study ID #: P081248
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2011
• Last updated: December 8, 2015
• Start date: May 2011
• Est. completion date: November 2015

Study information

• Verified date: July 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The eligible patients have to fulfill all the following criteria

1. patients admitted in intensive care unit

2. 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)

3. having peroperative microbiologic samples collected

4. receiving an empiric antibiotic therapy initiated within the first 24 hours after completion of surgery

5. 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 :

1. age<18

2. pregnancy

3. Duration of stay following inclusion <72 hours

4. neutropenia (PMN<500/mm3) due to chemotherapy or hematological disease

5. AIDS stage C

6. Immunosuppressive therapy or prolonged steroid therapy (=0.5 mg/kg/d of prednisone or equivalent >1 month

7. Bowel perforation following endoscopy treated in a delay <6 hours after injury

8. Uterine perforation following a surgical procedure treated in a delay <6 hours after injury

9. Moribund patient (SAPS II score >65 within 12 hours preceding inclusion)

10. Limitation of treatment previously decided

11. Surgery considered as non curative by the surgeon

12. 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

1. Negative culture of the peritoneal fluid

2. Peritoneal culture exclusively fungal

3. Inadequate empiric antibiotic therapy (not targeting all the microorganisms cultured from peritoneal or blood cultures) within 24 hours after surgery

4. Death between D1 and D8

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritonitis
• Postoperative Peritonitis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of antibiotic-free days at D28 after inclusion	The number of antibiotic-free days at D28 after inclusion (analysis of superiority)	28 days	No
Secondary	Mortality at D45 after inclusion	Mortality at D45 after inclusion (analysis of equivalence)	45 days	Yes
Secondary	Duration of ICU and hospital stay	Duration of ICU and hospital stay	45 days	No
Secondary	Changes in SOFA score	Changes in SOFA score	8 days	No
Secondary	Number of days alive without organ failure	Number of days alive without organ failure	28 days	No
Secondary	Failure rate for clinically evaluable patients	Failure rate for clinically evaluable patients	28 days	No
Secondary	Failure rate for microbiologically evaluable patients	Failure rate for microbiologically evaluable patients	28 days	No
Secondary	Rate of relapse within 45 days	Rate of relapse within 45 days	45 days	No
Secondary	Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples	Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples	ICU discharge	No
Secondary	Total cost of antibiotic agents	Total cost of antibiotic agents	28 days	No
Secondary	Evolution of procalcitonin plasma concentration	Evolution of procalcitonin plasma concentration	15 days	No
Secondary	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)	45 days	No
Secondary	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	Hospital discharge	No