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

A prospective observational study of real world treatment outcomes in patients receiving colistimethate sodium

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/03/004485
Enrollment
100
Registered
2014-03-19
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- Gram negative multidrug resistant bacterial infections

Interventions

Intervention1: Colistimethate sodium Inj.: â?¢The dosage (Strengths available 1 & 2 million IU) of colistimethate sodium, given as IV injection, will be as per the prescribing information or discretio

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Patients with hypersensitivity to colistimethate sodium or any exipients of its formulation. 2.Patients with Myasthenia gravis.

Design outcomes

Primary

MeasureTime frame
Clinical Parameters:Clinical and bacteriological response to the treatment.Timepoint: Throughout the study period

Secondary

MeasureTime frame
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 Timepoint: Throughout the study period;Incidence of drug related adverse events Timepoint: Throughout the study period;Incidence of inpatient mortalityTimepoint: Throughout the study period

Countries

India

Contacts

Public ContactMr Rahul Namjoshi

Apollo Hospitals

senthurnambi@gmail.com044-65367136

Outcome results

None listed

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