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PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis

NCT03388944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 561

Last updated 2025-03-03

No results posted yet for this study

Summary

The investigators' objective is to compare the risk of treatment failure\* in children admitted to the pediatric intensive care unit (PICU) with sepsis and managed by procalcitonin guided therapy for stopping of antibiotics ('PCT- guided therapy' group) with those managed with standard practices based on the evidence based guidelines ('control' group).

Children with suspected or proven sepsis will be randomized to the PCT guided group or the standard practices group and will be followed up for the outcome measures that include treatment failure and mortality. The investigators plan to enroll 560 patients over a period of 3 years. The investigators believe that the proposed study will provide the answer to reducing unnecessary antibiotic usage in the PICU without causing any harm to the patient in the form of treatment failure and/or mortality.

Conditions

Interventions

BEHAVIORAL

PCT group

In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER

  • St Johns Medical College Hospital, Bangalore, India

    collaborator OTHER

  • All India Institute of Medical Sciences, Bhubaneswar

    collaborator OTHER

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • S K Kabra, MD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388944 on ClinicalTrials.gov