Impact of Rapid Molecular Diagnostic Method on Antibiotics Exposure Duration in ICU Patients with Postoperative Peritonitis

NCT04925388 | Terminated

• 1 other identifier: APHP191112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 7

Brief Summary

Hospitals, and more specifically Intensive Care Units (ICU), face the challenging issue of emergence and rapid spread of multi-drug resistant bacteria (MDR). In some cases, the therapeutic choice is extremely limited. Prevention and adequacy of antibiotic therapy (AB) are the key responses applied toward these threats. A delayed adequate AB is a known factor of poor prognosis. Intra-abdominal infections (IAI) are frequent, polymicrobial and life threatening diseases. Source control and adequate AB are instrumental issues in this setting. Despite technical advances, susceptibility testing of the microorganisms collected from peritoneal samples is not usually available before day two or three after surgery. In this time lapse, empiric AB might be inadequate (not targeting all the pathogens, which leads to a prolonged duration of AB and potential increased morbidity/mortality risk) or too broad (with the two issues of ecology with an increased risk of selection of MDR bacteria and additional costs). In a pilot study evaluating the potential benefit of a direct culture of peritoneal samples from resuscitation patients treated for peritonitis, we observed that conventional treatment made it possible to obtain microbiological results within a median of 3 \[extremes 2-7\] days whereas a direct microbiological technique by E-test gave results in 1 \[1-2\] days (p \<0.0001). With this technique close to conventional microbiological, a change in antibiotic therapy could have been achieved within an average of 1 \[1-2\] days versus 4 \[1-11\] days with conventional management (p = 0, 0006). The development of modern molecular techniques suggests that a large margin of improvement for the rendering and the precision of the results is possible.

Conditions

Postoperative Peritonitis

Keywords

Antibiotics; Antifungal; Postoperative peritonitis; ICU; PCR

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with adequate anti-infective treatment on D1

  An anti-infective treatment is adequate if the anti-infective agents administered correspond to the simplest effective anti-infective treatment as determined by conventional microbiology

  day 1

Secondary Outcomes (15)

• The proportion of patients with adequate antibiotic treatment on D1

  day 1

• The proportion of patients with adequate antifungal treatment on D1

  day 1

• The proportion of patients with de-escalation on D1

  day 1

• The time in hours between randomization and adequate anti-infective treatment (antibiotic and antifungal)

  day 28

• The time in hours between randomization and adequate antibiotic treatment

  day 28

Study Arms (2)

multiplex PCR

EXPERIMENTAL

peritoneal samples will be analysed using Unyvero IAI test and using conventional method

Other: rapid molecular diagnosis; Other: conventional method analysis

conventional method

OTHER

peritoneal samples will be analysed using only conventional method

Other: conventional method analysis

Interventions

rapid molecular diagnosis OTHER

peritoneal samples will be analysed using Unyvero IAI test

multiplex PCR

conventional method analysis OTHER

peritoneal samples will be analysed using conventional method

conventional method; multiplex PCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible providing that they meet all the following criteria:
• having a surgery for a suspicion of post-operative peritonitis;

You may not qualify if:

• Patients will not be eligible if they meet at least one of the following criteria
• age under 18 years;
• current pregnancy;
• patient for whom a limitation of care has been decided
• patient included in another therapeutic trial involving antibiotics agents
• patient who has already participated in this study
• patients unable to give consent (under guardianship or curatorship)
• patient not affiliated to social security
• Randomization criteria:
• surgical samples collected during reoperation for microbiological purpose;
• the two surgical samples can be processed by the microbiology laboratory within a maximum period of 8 hours between the start of the two techniques

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (7)

Amiens-Picardie Hospital

Amiens, France

Location

Chartres Hospital

Chartres, France

Location

Beaujon Hospital

Clichy, France

Location

Bichat Hospital

Paris, France

Location

Lariboisiere Hospital

Paris, France

Location

Saint Antoine Hospital

Paris, France

Location

Charles Nicolle Hospital

Rouen, France

Location

Study Officials

• Philippe Montravers, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 14, 2021
• Study Start: December 30, 2022
• Primary Completion: February 6, 2024
• Study Completion: March 5, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)