MedPath

Comparing long and short duration antibiotics for abdominal infections

Phase 3
Conditions
Health Condition 1: null- Complicated Intra-abdominal Infections
Registration Number
CTRI/2018/03/012682
Lead Sponsor
Jawaharlal Institute of PostGraduate Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients of complicated intra-abdominal infections (CIAI) who undergo surgical intervention to achieve adequate source control + one or more of the following:

1. Temperature <=36C or >= 38 C

2. WBC count<=4000 or >= 11,000/mm3

3. Gastrointestinal dysfunction due to peritonitis, precluding intake of more than half their normal diet (as an indicator of an ileus)

Exclusion Criteria

1. Non-perforate, non-gangrenous appendicitis or cholecystitis

2. Infected necrotizing pancreatitis.

3. Primary spontaneous bacterial peritonitis

4. Infection associated with indwelling peritoneal dialysis catheter

5.High likelihood of death within 72h[ Patients in the post operative period who require two ionotropes to maintain hemodynamic stability and are above the age of 65]

6.Pregnancy

7.Concurrent infection requiring more than five days of antimicrobial therapy or various antimicrobial regimen.

8.Patients undergoing planned re-laparotomy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Surgical-site infection, <br/ ><br>2. Recurrent intra-abdominal infection requiring either surgical or percutaneous re-intervention <br/ ><br>3. 30 day mortality <br/ ><br>between the groups of patients with complicated intra-abdominal infection (CIAI), receiving conventional antimicrobial therapy and short course antimicrobial therapy <br/ ><br>Timepoint: 30 days
Secondary Outcome Measures
NameTimeMethod
To compare the Antimicrobial-free days at 30 days between the two groups.Timepoint: 30 days;To compare the duration of antimicrobial therapy for index infection between the two groupsTimepoint: 30 days;To compare the rates of individual primary end point components between the two groupsTimepoint: 30 days;To compare the time to the occurrence of the composite primary outcome between the two groupsTimepoint: 30 days
© Copyright 2025. All Rights Reserved by MedPath