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

• Conditions: Mild to severe Bacterial infections( in Lower Respiratory Tract infection, Endocarditis, Skin infection, Meningitis, Bone infection.)

• Registration Number: CTRI/2008/091/000060
• Lead Sponsor: Venus Remedies Limited

Brief Summary

This is a open-labeled,double arm, randomized,multi-centric, trial TO EVALUATE THE SAFETY AND EFFICACY OF FIXED DOSE COMBINATION OF CEFTRIAXONE AND VANCOMYCIN INJECTION Vs. VANCOMYCIN INJECTION IN SUBJECTS WITH VARIOUS BACTERIAL INFECTIONS with 200 patients for 6 months that will be conducted in five centres in India.

Detailed Description

Not available

Recruitment & Eligibility

• 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 disorderPregnancy&/or lactationAlcoholics.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
evaluate the safety of the test and comparative product

Trial Locations

Locations (5)

AIIMS; 🇮🇳 Delhi, DELHI, India

Dr. Hedgewar Arogya Sansthan; 🇮🇳 Delhi, DELHI, India

Kempegowda Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Lokmanya Tilak Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

S.P. Medical College; 🇮🇳 Bikaner, RAJASTHAN, India

AIIMS

🇮🇳Delhi, DELHI, India

Dr. Namit Saraf

Principal investigator

09891290198

drnamitsaraf@rediffmail.com