A study to determine safety and efficacy of patients receiving colistin.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Gram negative multidrug resistant bacterial infections
- Registration Number
- CTRI/2014/03/004485
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Greater than 18 years
2.A written informed consent
3.Patients suitable for treatment with colistimethate sodium, including immuno-compromised patients
Exclusion Criteria
1.Patients with hypersensitivity to colistimethate sodium or any exipients of its formulation.
2.Patients with Myasthenia gravis.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Parameters:Clinical and bacteriological <br/ ><br>response to the treatment.Timepoint: Throughout the study period
- Secondary Outcome Measures
Name Time Method Clinically significant changes in the vital signs, systemic examinations, ECG, chest radiograph and laboratory valuesTimepoint: Throughout the study period;Incidence and nature of adverse events <br/ ><br>Timepoint: Throughout the study period;Incidence of drug related adverse events <br/ ><br>Timepoint: Throughout the study period;Incidence of inpatient mortalityTimepoint: Throughout the study period