Efficacy of probiotics combined with antibiotics in critically ill children with severe infectio
Not Applicable
- Conditions
- Health Condition 1: null- Sepsis
- Registration Number
- CTRI/2012/07/002830
- Lead Sponsor
- ICMR Applied for
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
a)Children in the age range 3 months to 12 years who are admitted in pediatric intensive care unit
b)Children with a diagnosis of severe sepsis as defined by ACCM/SCCM guidelines and needing broad spectrum antibiotics > 48 hours
c)Informed consent from parents
Exclusion Criteria
a)Antibiotic received for > 48 hrs prior to enrolment
b)Known immunodeficiency
c)On immunosuppressive therapy for > 7 days
d)Probiotic treatment in last 7 days
e)Previous enrolment in study
f)Prior hospitalization for > 48 hours in last 7 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i)To evaluate whether probiotic added as an adjunct to antibiotic treatment reduces the duration of IV antibiotic therapy in children with severe sepsis.Timepoint: reduction in duration of antibiotic therapy by â?¥ 20% in children with severe sepsis who receive probiotic as an adjunct as compared to children who receive placebo. This will be measured at 7 days, 14 days and at discharge.
- Secondary Outcome Measures
Name Time Method Role of probiotic as an adjunct therapy on in-PICU mortality. <br/ ><br>Compare incidence of secondary/nosocomial infection in the both groups. <br/ ><br>Compare improvement in laboratory markers of sepsis in the both groups at 72 hours, day 5 & 7 post enrollment. <br/ ><br>Compare Sequential Organ Failure Score in both groups from day 0 onwards till discharge. <br/ ><br>Adverse events of probiotics in critically ill childrenTimepoint: At day 3, 5, 7 and at discharge