Health Condition 1: null- Urinary Tract Infection, Skin and skin structure infections, Bone and joint infections, Septicemia, Surgical prophylaxis, bacterial ottitis media, Meningitis,LRTI
Conditions
Interventions
Intervention1: CSE 1034: 3g, OD, I.V.
Control Intervention1: Ceftriaxone: 2g, OD, interavenous injection
Sponsors
Venus Remedies Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of fixed dose combination of Ceftriaxone + sulbactam + non-antibiotic adjuvant EDTA (CSE 1034) as compared to monotherapy of Ceftriaxone in subjects suffering from different bacterial infections.Timepoint: Clinical evaluation and Bacteriological evaluation on screening and on completion of treatment. Various clinical investigations shall be done | — |
Secondary
| Measure | Time frame |
|---|---|
| to establish safety of CSE 1034 vs ceftraioxneTimepoint: In addition to clinical observations Safety shall be assessed by clinical investigations. Non occurrence of drug related adverse events | — |
Countries
India
Contacts
Public ContactMr Pankaj
Venus Clinical Research Services
Outcome results
None listed