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PCT guided antibiotic stoppage in children with sepsis

Procalcitonin Level Guided Cessation of Antibiotic Therapy in Children with Sepsis: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008509
Enrollment
560
Registered
2017-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: null- Sepsis Health Condition 2: A419- Sepsis, unspecified organism

Interventions

Intervention1: PCT group: In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission. PCT levels will be obtained at admission and every 3rd day thereaft

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 2. children who are started on antibiotics in the ICU for suspected or proven sepsis

Exclusion criteria

Exclusion criteria: 1. Children receiving antibiotics more than 24 hours before presentation, 2. Those with severe immunosuppression (CD4 count of less than 200 cells/mm3 neutropenic patients ( 3. Estimated length of stay less than 24 hrs, 4. Underlying co-morbidities with possible imminent death, 5. Severely malnourished children and 6. Children whose parents refuse to give an informed consent

Design outcomes

Primary

MeasureTime frame
Proportion with treatment failure during the course of ICU stayTimepoint: Measured from 48 hours after stopping antibiotics till discharge or death

Secondary

MeasureTime frame
1. Proportion of children who are clinically cured (defined as resolution of signs and symptoms for which antibiotics were started). 2. Proportion developing septic shock or ARDS during the course. 3. Duration of antibiotic therapy in overall population and as per type/ source/ site infection Timepoint: 1. Measured after first antibiotic course from the time of admission 2. Measured from the time of stopping the antibiotic therapy 3. Total duration of antibiotic therapy during the ICU stay including the first course

Countries

India

Contacts

Public ContactJhuma Sankar

All India Institute of Medical Sciences

jhumaji@gmail.com9818399864

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026