Multicentric clinical trial on the efficacy and safety of ceftriaxone and sulbactam in lower respiratory tract infectio
Completed
- Conditions
- ower respiratory tract infectionInfections and InfestationsRespiratory tract infection
- Registration Number
- ISRCTN51896330
- Lead Sponsor
- Venus Remedies Limited (India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
1. Age =18 years
2. Fever =38°C
3. Sputum pus cells >25 high power fields (HPF)
4. Buccal epithelial cells <10 HPF
Exclusion Criteria
1. Hypersensitivity to ceftriaxone, sulbactam or related drugs
2. Children less than 18 years of age
3. Septicemic shock, active pulmonary malignancies, renal and hepatic insufficiencies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The overall efficacy of fixed dose combination (FDC) of ceftriaxone and sulbactam was excellent. The clinical cure rate was 77.14% and the bacteriological cure rate was 100%. A total of three adverse reactions were noted in 12 of the 105 patients receiving ceftriaxone and sulbactam (FDC) but none of them warranted discontinuation of treatment. Adverse effects noted included: pain at the injection site (5.7%), superficial thrombophlebitis (4.76%), and mild diarrhea (0.95%).
- Secondary Outcome Measures
Name Time Method Ceftriaxone and sulbactam in fixed dose combination (FDC) is an effective and well-tolerated antimicrobial agent that appears promising for the treatment of serious lower respiratory tract infections