Status:
COMPLETED
PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
Post Graduate Institute of Medical Education and Research, Chandigarh
St Johns Medical College Hospital, Bangalore, India
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
2-17 years
Phase:
NA
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 ...
Detailed Description
Sepsis and bacterial infections account for more than 50% of and intensive care (ICU) admissions and the mortality rates are as high as 40-60% reported in various studies. Although, antibiotics are cr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT03388944
Start Date
October 21 2019
End Date
February 28 2023
Last Update
March 3 2025
Active Locations (2)
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1
St Johns Medical College and Hospital
Bengaluru, Karnataka, India, 560034
2
PGIMER
Chandigarh, India