A clinical trial to assess efficacy and safety of a fixed dose combination of meropenam and sulbactam in lower respiratory tract infection caused by Gm (-ve) organisms including Pseudomonas aeruginosa.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Lower respiratory tract infections caused by Gm (-ve) organisms including Pseudomonas aeruginosa with culture showing the organisms
- Registration Number
- CTRI/2010/091/000569
- Lead Sponsor
- MsVHB Medisciences 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 age group of 18-60 years have been selected.
2. Clinically diagnosed subjects lower respiratory infection with Gram (-)ve.
3. Subjects willing to give informed consent.
4. Patient must not have received any antibiotics in previous 4 week.
Exclusion Criteria
1. History of hypersensitivity reaction or any specific contraindication to ofloxacin or ornidazole or Quinolone group or nitoimidazole group.
2. Presence of hepatic or renal disorders,
3. Pregnancy or lactation,
4. History of hearing loss,
5. Alcoholics
6. Previous history seizure or taking anti epileptic drugs.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical improvement & bacteriological conversion (when applicable) are the primary end-points and are defined as a subject who is <br>(1)Afebrile for 48 hours, <br>(2)Improvement of X-ray lesion as compared to pre-treatment, <br>(3)sensitivity tests show absence of infecting organisms detected on initial culture on completion of 7 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment particularly those cases where bacterial positivity persist in 7 days report. <br><br>Timepoint: 3rd day, 7th day and 10th day
- Secondary Outcome Measures
Name Time Method <br>Time for complete resolution defined as <br>(1)Complete resolution of all symptoms of respiratory infection,<br>(2)The number of days after beginning treatment with FDC to discharge. <br>Timepoint: 7th day and 10th day