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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65171867
Enrollment
200
Registered
2006-06-23
Start date
2005-11-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Nosocomial pneumonia Infections and Infestations Pneumonia

Interventions

100 Patients were treated with cefepime and amikacin fixed-dose combination (FDC) 2.5 g twice a day (bid) and 100 patients received cefepime 2 g bid for 7-10 days

Sponsors

Venus Remedies Limited (India)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026