An Observational Study to Evaluate the Safety and Tolerability of Minocycline Hydrochloride Injection in Indian Patients with Multi Drug Resistant Gram-Negative Bacterial Infections.

Not Applicable

Recruiting

• Conditions: Bacterial infection, unspecified, The patients with Multi Drug Resistant Gram Negative Bacterial Infections.,

• Registration Number: CTRI/2018/04/013319
• Lead Sponsor: Cipla Ltd

Brief Summary

This is an observational, practice-based, open-label, multicenter, post-marketing surveillance study. This study is to assess the safety and tolerability of minocycline hydrochloride 100 mg intravenous (I.V.) injection in Indian patients with multi-drug resistant gram (MDR) negative bacterial infections. Patients who are hospitalized with a confirmed MDR gram-negative bacterial infections will be enrolled in this study

The study duration will be at the discretion of the investigator.

Croissance Clinical Research is providing the Clinical Trial management Support to this clinical study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Written signed and dated informed consent (patient or LAR) 2.
• Either gender with age 18 years and above 3.
• Patients with Multi-Drug Resistant (MDR) gram negative bacterial infection 4.
• Documented bacteriological infection susceptible to Minocycline Hydrochloride.

Exclusion Criteria

• Known hypersensitivity to Minocycline Hydrochloride or any of its components 2.
• Patient unsuitable to participate in the study as per the discretion of investigator 3.
• Pregnant or nursing females 4.
• Any other condition in the opinion of the investigator would affect the safety of the patient if Minocycline Hydrochloride is administered.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related)	During Treatment period
2.Percentage of patients with adverse events	During Treatment period
3.Treatment discontinuation rates	During Treatment period

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (3)

Apollo Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Mazumdar Shaw Medical Center A Unit of Narayana Hrudayalaya; 🇮🇳 Bangalore, KARNATAKA, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Apollo Hospitals

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Rajib Paul

Principal investigator

9849079541

drrajibpaul@gmail.com