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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01311765
First received: February 22, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 without increased mortality between day 8 and day 45.


Condition Intervention Phase
Postoperative Peritonitis
Other: Duration of antibiotic therapy limited to 8 days
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The number of antibiotic-free days at D28 after inclusion [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The number of antibiotic-free days at D28 after inclusion (analysis of superiority)

  • Mortality at D45 after inclusion [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
    Mortality at D45 after inclusion (analysis of equivalence)


Secondary Outcome Measures:
  • Duration of ICU and hospital stay [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Duration of ICU and hospital stay

  • Changes in SOFA score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Changes in SOFA score

  • Number of days alive without organ failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of days alive without organ failure

  • Failure rate for clinically evaluable patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Failure rate for clinically evaluable patients

  • Failure rate for microbiologically evaluable patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Failure rate for microbiologically evaluable patients

  • Rate of relapse within 45 days [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Rate of relapse within 45 days

  • Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
    Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples

  • Total cost of antibiotic agents [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Total cost of antibiotic agents

  • Evolution of procalcitonin plasma concentration [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration


Estimated Enrollment: 244
Study Start Date: May 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Name: Duration of antibiotic therapy limited to 8 days
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

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 without increasing mortality. 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 are the number of antibiotic-free days at D28 after inclusion (analysis of superiority) and mortality at D45 after inclusion (analysis of equivalence). Secondary endpoints include 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311765

Contacts
Contact: Philippe Montravers, MD, PhD 33(0)1 40 25 83 55 philippe.montravers@bch.aphp.fr
Contact: Hervé Dupont, MD, PhD 33(0)3.22.66.83.80 dupont.herve@chu-amiens.fr

Locations
France
Hôpital Bichat Recruiting
Paris, France, 75018
Contact: Philippe Montravers, MD, PhD    33(0)1 40 25 83 55    philippe.montravers@bch.aphp.fr   
Contact: Hervé Dupont, MD, PhD    33(0)3.22.66.83.80    dupont.herve@chu-amiens.fr   
Principal Investigator: Philippe Montravers, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Montravers, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01311765     History of Changes
Other Study ID Numbers: P081248
Study First Received: February 22, 2011
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postoperative peritonitis
Intra-abdominal infection
Surgery
Laparotomy
Nosocomial infection
Antibiotic therapy
Duration of treatment
Multidrug resistant bacteria

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014