Comparing long and short duration antibiotics for abdominal infections

Comparison of short course antimicrobial therapy vs. conventional antimicrobial therapy in patients with complicated intra-abdominal infections- A randomized control trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012682

Enrollment

140

Registered

2018-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Short course anti-microbial therapy: Anti-microbial as per surgical unit protocol Intervention2: Short course anti-microbial therapy: Anti-microbial as per surgical unit protocol. Admin

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Surgical-site infection, 2. Recurrent intra-abdominal infection requiring either surgical or percutaneous re-intervention 3. 30 day mortality between the groups of patients with complicated intra-abdominal infection (CIAI), receiving conventional antimicrobial therapy and short course antimicrobial therapy Timepoint: 30 days	—

Secondary

Measure	Time frame
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;To compare the duration of antimicrobial therapy for index infection between the two groupsTimepoint: 30 days;To compare the Antimicrobial-free days at 30 days between the two groups.Timepoint: 30 days	—

Measure

Time frame

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;To compare the duration of antimicrobial therapy for index infection between the two groupsTimepoint: 30 days;To compare the Antimicrobial-free days at 30 days between the two groups.Timepoint: 30 days

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Countries

India

Contacts

Public ContactProf Vikram Kate

Jawaharlal Institute of Post-Graduate Medical Education and Research

drvikramkate@gmail.com

Outcome results