Multicentric, randomized, comparative, open-labeled trial of a fixed dose combination of cefepime and amikacin versus cefepime alone in nosocomial pneumonia

Completed

• Conditions: osocomial pneumonia; Infections and Infestations; Pneumonia

• Registration Number: ISRCTN65171867
• Lead Sponsor: Venus Remedies Limited (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Participants included were 200 patients infected with nosocomial pneumonia showing presence of pus cells more than 25 high power fields (HPF) and buccal epithelial cells less than 10 HPF

Exclusion Criteria

1. Hypersensitivity to cefepime, amikacin or related drugs
2. Children or adolescents less than 18 years of age
3. Pregnant women
4. Patients with renal or hepatic insufficiency
5. Patients not willing to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome of therapy was based on clinical evaluation and bacteriological evaluation. Bacteriological evaluation was in terms of presence or absence of bacteria in sputum.

Secondary Outcome Measures

Name	Time	Method
The cure rate was 65% in the cefepime and amikacin FDC group while clinical improvement was noticed in 24% of the patients. In the group treated with cefepime alone, the cure rate was 44%, while 27% showed clinical improvement. Mild adverse reactions were noticed in both groups.