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

â??An Open Labelled, Double Arm, Randomized, Multicentric, Prospective And Comparative, Phase-III 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.â??

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000060

Enrollment

200

Registered

2008-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Vancomycin and Ceftriaxone combined: 6 gm i.v in two equally divided slow doses, depending on the severity of disease Control Intervention1: VANCOMYCIN: 2 g divided either as 500 mg eve

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
evaluate the safety of the test and comparative productTimepoint:	—

Countries

India

Contacts

Public ContactMahesh Mudgal

drnamitsaraf@rediffmail.com09891290198

Outcome results