A clinical trial to determine pharmacokinetics of Colistin given as injection, in subjects with hospital acquired infections caused by gram negative bacilli.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Nosocomial infections caused by multidrug resistant, gram negative bacilli.
- Registration Number
- CTRI/2009/091/000252
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1.Written, signed, dated institutional ethics committee approved informed consent obtained from subjects or legally acceptable representative, before performing any screening procedures.
2.Both male and female subjects of between18 and 65 years
3.Subjects with nosocomial infections caused by multidrug resistant, gram negative bacilli, bacteriologically documented.
Exclusion Criteria
1.Subjects with hypersensitivity to colistimethate sodium or any exipients of its formulation.
2.Subjects with creatinine clearance less than 10 mL/min.
3.Subjects of Myasthenia gravis.
4.Participation in any investigational study within 30 days prior to screening.
5.Female who is pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacological Parameters: Cmax, Tmax,AUC0-t, AUC0-∞, Cmax/MIC, Cssmax, Tssmax, Cssmax/MIC, Css min, Mean Retention timeTimepoint: Day 1, Steady state, first 7 days.
- Secondary Outcome Measures
Name Time Method Clinical Parameters:Clinical and bacteriological response to the treatment, Safety parameters:Incidence of inpatient mortality,Incidence and nature of adverse events,Incidence of drug related adverse events,Clinically significant changes in the vital signs, systemic examinations,ECG, chest x-ray and laboratory values. <br/ ><br>Timepoint: Through out the study period. Duration of the treatment period is minimum 8 days.