A clinical trial to compare the efficacy and safety of fixed dose combination of cefoperazone and tazobactam with cefoperazone alone in infections caused by Gm(-ve) organisms.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Gm (-ve) infections with culture showing the organisms.
- Registration Number
- CTRI/2010/091/000484
- Lead Sponsor
- Ms Kilitch DrugsIndia Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Male and female subjects in the aged group of 18-60 years shall be selected.
2. Clinically diagonised subjects with gm (-ve) infections with culture showing the organisms.
3. Subjects willing to give informed consent.
4. Patient must not have received any antibiotics in previous 4 weeks.
Exclusion Criteria
1. History of hypersensitivity reaction or any specific groups.
2. Presence of severe hepatic or renal disorders.
3. Pregnancy or lactation.
4. History of hearing loss.
5. Previous history seizure.
6. Alcoholic.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method