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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311765
First Posted: March 10, 2011
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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.

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

Study Type: Interventional
Study Design: 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

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 ]
    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


Enrollment: 244
Study Start Date: May 2011
Study Completion Date: November 2015
Primary Completion Date: March 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
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 . 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01311765     History of Changes
Other Study ID Numbers: P081248
First Submitted: February 22, 2011
First Posted: March 10, 2011
Last Update Posted: December 9, 2015
Last Verified: July 2015

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
Antitubercular Agents