Colistin loading dose in pediatrics
Phase 3
- Conditions
- Condition 1: bloodstream infections. Condition 2: Ventilator Associated Pneumonia.
- Registration Number
- IRCT20170614034532N2
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Colistin receiving for at least four days
Normal baseline renal status before administration of Colistin
Children from 1 month to 18 years
Children with a positive blood culture or VAP
Gram negative culture which is only susceptible to Colistin
Exclusion Criteria
Parents Dissatisfaction
Receiving Nebulized form of Colistin for VAP
Receiving antibiotics effective on gram negative micro organisms other than Colistin and Meropenem
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response. Timepoint: at the beginning of the study (before starting the intervention) and 72 hours after the start of treatment. Method of measurement: Laboratory data.;Microbiological response. Timepoint: at the beginning of the study (before starting the intervention) and 72 hours after the start of treatment. Method of measurement: Microbial culture.
- Secondary Outcome Measures
Name Time Method The prevalence and severity of Nephrotoxicity. Timepoint: 72hrs after starting Colistin. Method of measurement: Laboratory data; Measurement of Urine Volume.;The prevalence of Neurotoxicity. Timepoint: 72hrs after starting Colistin. Method of measurement: Clinical outcomes.;The prevalence of Colistin resistance. Timepoint: 72hrs after starting Colistin. Method of measurement: Microbial culture.