A comparative clinical study to evaluate efficacy and safety of fixed dose combination of Ceftriaxone + Sulbactam (CSE 1034) vs Ceftriaxone in patients suffering from various bacterial infections
Phase 3
Completed
- Conditions
- Health Condition 1: null- Urinary Tract Infection, Skin and skin structure infections, Bone and joint infections, Septicemia, Surgical prophylaxis, bacterial ottitis media, Meningitis,LRTI
- Registration Number
- CTRI/2010/091/000174
- Lead Sponsor
- Venus Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 654
Inclusion Criteria
Male and female subjects in the age group of 12-65 years
Clinically diagnosed subjects with Urinary Tract Infection, Skin and skin structure infections, Bone and joint infections, Septicemia, Surgical prophylaxis, acute bacterial ottitis media, Meningitis,LRTI(Lower respiratory tract infections)
Adult patient willing to give written informed consent. Parent or LAR of minor patients ready to give written informed consent.
Exclusion Criteria
History of hypersensitivity reaction or any specific contraindication to pencillin group of drugs or cephalosporins or ceftriaxone and sulbactam.
Presence of hepatic or renal disorder
History of hearing loss
Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of fixed dose combination of Ceftriaxone + sulbactam + non-antibiotic <br/ ><br>adjuvant EDTA (CSE 1034) as compared to monotherapy of Ceftriaxone in subjects suffering from different <br/ ><br>bacterial infections.Timepoint: Clinical evaluation and Bacteriological evaluation on screening and on completion of treatment. <br/ ><br>Various clinical investigations shall be done
- Secondary Outcome Measures
Name Time Method to establish safety of CSE 1034 vs ceftraioxneTimepoint: In addition to clinical observations Safety shall be assessed by clinical investigations. <br/ ><br>Non occurrence of drug related adverse events