PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis

NCT03388944 | Completed DMC

• 1 other identifier: IEC-531/11.11.2016
• Study Type: interventional
• Target: 561
• Locations: 1 country
• Sites: 2

Brief 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

Sepsis; Septic Shock; Antibiotic Use; Procalcitonin; PCT; Antimicrobial Resistance; AMR

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  The primary outcome measure would be treatment failure\* (defined as growth of one or more of the initial causative organism(s) from a second sample taken within 48 hours after stopping antibiotics and/ or clinical signs or symptoms of infection) within 7 days of stoppage of antibiotics.

  From day of stopping first course of antibiotic therapy till day 7 after stopping antibiotics

Secondary Outcomes (3)

• Proportion clinically cured

  From day of stopping first course of antibiotic therapy till day 7 of stopping therapy

• Antibiotic free days

  Till day 28 of hospital stay

• Mortality

  Till death or day 28 whichever is earlier

Study Arms (2)

PCT group

EXPERIMENTAL

PCT group

Behavioral: PCT group

Standard practice group

NO INTERVENTION

No intervention

Interventions

PCT group BEHAVIORAL

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

PCT group

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 2 month to 17 years admitted to the ICU and already receiving antibiotics for suspected or proven sepsis (defined as systemic inflammatory response syndrome or SIRS due to infection) and children who are started on antibiotics in the ICU for suspected or proven sepsis will be included.

You may not qualify if:

• Children receiving antibiotics more than 24 hours before presentation
• Children with severe immunosuppression (CD4 count of less than 200 cells/mm3, neutropenic patients (\<500 neutrophils/ml)) other than corticosteroid use
• Children admitted for post-op observation
• Children with an estimated length of stay less than 24 hrs
• Children with underlying co-morbidities with possible imminent death
• Children whose parents refuse to give an informed consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• St Johns Medical College Hospital, Bangalore, India: collaborator
• All India Institute of Medical Sciences, Bhubaneswar: collaborator

Study Sites (2)

St Johns Medical College and Hospital

Bengaluru, Karnataka, 560034, India

Location

PGIMER

Chandigarh, India

Location

Related Links

• Clinical Trials Registry of India - Registered trial

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• S K Kabra, MD

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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 primary outcome measure that includes treatment failure. We would also be comparing the duration of antibiotic therapy and mortality between the two groups as secondary outcome measures.

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: January 3, 2018
• Study Start: October 21, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)