A study to determine safety and efficacy of patients receiving colistin.

Not Applicable

Completed

Conditions: Gram negative multidrug resistant bacterial infections

Registration Number: CTRI/2014/03/004485

Lead Sponsor: Cipla Ltd

Brief Summary: This clinical trial is a prospective observational study for determination of real world treatment outcomes in subjects with gram negative multidrug resistant bacterial infections receiving colistimethate sodium. 100 patients will be recruited in this study at single site in India. Patients will receive the colistimethate sodium treatment as per the discretion of treating physician.

Primary outcome measures will be Clinical and bacteriological response to the treatment. Safety parameters will be assessed as a secondary measures..

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

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	Throughout the study period
response to the treatment.	Throughout the study period

Secondary Outcome Measures

Name	Time	Method
Incidence and nature of adverse events
Incidence of inpatient mortality	Throughout the study period
Incidence of drug related adverse events
Clinically significant changes in the vital signs, systemic examinations, ECG, chest radiograph and laboratory values	Throughout the study period

Trial Locations

Locations (1): Apollo Hospitals
🇮🇳
Chennai, TAMIL NADU, India
Apollo Hospitals
🇮🇳Chennai, TAMIL NADU, India
Dr Senthur Nambi
Principal investigator
044-65367136
senthurnambi@gmail.com