A clinical trial to determine pharmacokinetics of Colistin given as injection, in subjects with hospital acquired infections caused by gram negative bacilli.

Pharmacokinetics of Colistin, after intravenous administration of colistimethate sodium in subjects with nosocomial infections caused by multidrug resistant, gram negative bacilli.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000252

Enrollment

Registered

2009-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Nosocomial infections caused by multidrug resistant, gram negative bacilli.

Interventions

Intervention1: Colistimethate sodiumIntravenous Infusion: For subjects weighing 60 Kg and above: 1.With normal renal function or creatinine clearance 20-50 mL/min will be administered 2 million units

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. Timepoint: Through out the study period. Duration of the treatment period is minimum 8 days.	—

Measure

Time frame

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. Timepoint: Through out the study period. Duration of the treatment period is minimum 8 days.

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Countries

India

Contacts

Public ContactDr Niteen Karnik

Cipla Ltd.

jgogtay@cipla.com022-23025412

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026