CTRI/2009/091/000252CompletedPhase 4
Pharmacokinetics of Colistin, after intravenous administration of colistimethate sodium in subjects with nosocomial infections caused by multidrug resistant, gram negative bacilli.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cipla Ltd
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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
Investigators
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