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A clinical trial to study the safety and efficacy of combination drug, vancomycin and ceftriaxone compared to vancomycin in mild to severe bacterial infections

Phase 3
Registration Number
CTRI/2008/091/000060
Lead Sponsor
Venus Remedies Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

All subjects aged between 18 and 70 years.
Diagnosed subjects of infectious disease (on clinical evaluation).
Subjects willing to give informed consent.
Subject suffering from any of the following infections- Lower respiratory tract infections, skin and skin structure infections, endocarditic, bacterial meningitis and bone infection.

Exclusion Criteria

History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs or Ceftriaxone or Vancomycin.
Presence of hepatic or renal disorder
Pregnancy&/or lactation
Alcoholics

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
compare the efficacy of a 3.0g FDC of Ceftriaxone and Vancomycin Injection Vs. 1.0g Vancomycin Injection in subjects with Mild to Severe Bacterial infections.Timepoint:
Secondary Outcome Measures
NameTimeMethod
evaluate the safety of the test and comparative productTimepoint:
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