Sepsis Clinical Trial
Official title:
Procalcitonin Level Guided Cessation of Antibiotic Therapy in Children With Sepsis: A Randomized Controlled Trial
Verified date | July 2023 |
Source | All India Institute of Medical Sciences, New Delhi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 561 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 17 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
India | St Johns Medical College and Hospital | Bengaluru | Karnataka |
India | PGIMER | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi | Jawaharlal Institute of Postgraduate Medical Education & Research, Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Proportion clinically cured | Proportion clinically cured after the first antibiotic course | From day of stopping first course of antibiotic therapy till day 7 of stopping therapy | |
Secondary | Antibiotic free days | Total number of days the patients are not on antibiotics | Till day 28 of hospital stay | |
Secondary | Mortality | Death in ICU or hospital | Till death or day 28 whichever is earlier |
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