Safety and efficacy of a fixed dose combination of cefepime and amikaci

Completed

• Conditions: osocomial pneumonia, febrile neutropenia, other bacterial infections; Infections and Infestations; Infections

• Registration Number: ISRCTN61799591
• Lead Sponsor: Venus Remedies Limited (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

1. Hospitalised patients of either sex
2. Above 18 years of age
3. Clinically diagnosed subjects with moderate to severe infections of:
3.1. Febrile neutropenia (n = 110)
3.2. Nosocomial pneumonia (n = 110)
3.3. Other bacterial infection (n = 91)

Exclusion Criteria

1. History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs
2. Hepatic or renal disorder or any heart disorder
3. Pregnancy and/or lactation
4. History of hearing loss
5. Alcoholics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in clinical and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT).

Secondary Outcome Measures

Name	Time	Method
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT).