An Observational Study to Evaluate the Safety and Tolerability of Minocycline Hydrochloride Injection in Indian Patients with Multi Drug Resistant Gram-Negative Bacterial Infections.
Phase 4
- Conditions
- Health Condition 1: A499- Bacterial infection, unspecifiedHealth Condition 2: null- The patients with Multi Drug Resistant Gram Negative Bacterial Infections.
- Registration Number
- CTRI/2018/04/013319
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. 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
1. 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) <br/ ><br>2.Percentage of patients with adverse events <br/ ><br>3.Treatment discontinuation ratesTimepoint: During Treatment period <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable