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.
- Conditions
- Gm (-ve) infections with culture showing the organisms.
- Registration Number
- CTRI/2010/091/000484
- Lead Sponsor
- Ms Kilitch DrugsIndia Ltd
- Brief Summary
This study is a comparative, Single blind, multi-centre trial, comparing the safety and efficacy of FDC containing cefoperazone & tazobactam and cefoperazone alone twice daily for 7-14 days in 200 patients with infections caused by Gm (-ve) organisms that will be conducted in four centers in India. The primary outcome measures will be clinical improvement and bacteriological conversion (when applicable). The secondary outcome will be complete resolution of all symptoms of infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- Male and female subjects in the aged group of 18-60 years shall be selected.
- Clinically diagonised subjects with gm (-ve) infections with culture showing the organisms.
- Subjects willing to give informed consent.
- Patient must not have received any antibiotics in previous 4 weeks.
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 Clinical improvement and bacteriological conversion(when applicable) are the primary outcome and are defined as a subject who is -afebrile for 48 hours.-Improvement of X-ray lesion in lower respiratory tract infection as compared to pretreatment.-Isolation tests show the reduction or absence of infecting organisms detected in initial cultures on 48 hours, 7 days, 14 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment.
- Secondary Outcome Measures
Name Time Method The time for complete resolution defined as -complete resolution of all symptoms of infection.-The number of days after beginning treatment with FDC of cefoperazone & tazobactam or cefoperazone alone to discharge.
Trial Locations
- Locations (4)
Bankura Sammilani Medical College
🇮🇳Bankura, WEST BENGAL, India
Dafodil Nursing Home Pvt. Ltd.
🇮🇳Kolkata, WEST BENGAL, India
Dr. Bhagat?s Allergy- Asthma Clinic And Respiratory Care Centre, ?Pathik?,
🇮🇳Ahmadabad, GUJARAT, India
KPC Medical College & Hospital
🇮🇳Kolkata, WEST BENGAL, India
Bankura Sammilani Medical College🇮🇳Bankura, WEST BENGAL, IndiaDr. Balaram GhoshPrincipal investigator09433412788drbrghosh@gmail.com