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ISRCTN
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ISRCTN65171867
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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RCCT
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Serial number at source
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06-PLCT-CT-00037
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Study hypothesis
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The objective of the trial was to compare the efficacy and safety of cefepime and amikacin fixed dose combination with cefepime alone in patients with nosocomial pneumonia.
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Lay summary
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Ethics approval
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Approval given by Institutional Ethics Committee, reference number: Ct/ca/01
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Study design
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Open-labeled, randomized controlled clinical trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Nosocomial pneumonia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2005
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Anticipated end date
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31/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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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
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Primary outcome measure(s)
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Outcome of therapy was based on clinical evaluation and bacteriological evaluation. Bacteriological evaluation was in terms of presence or absence of bacteria in sputum.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Venus Remedies Limited
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Trial website
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Publications
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Contact name
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Prof
K.C
Mohanty
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Address
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Professor and Head
K.J.Somaiya Medical Hospital and Research Centre
Department of Chest Medicine
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City/town
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Mumbai
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Zip/Postcode
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400022
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Country
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India
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Sponsor
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Venus Remedies Limited (India)
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Address
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Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
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City/town
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Haryana
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Zip/Postcode
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134113
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Country
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India
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Tel
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+91 17 22561244
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Fax
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+91 17 22565566
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Email
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operations@venusremedies.com
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Sponsor website:
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http://www.venusremedies.com
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Date applied
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06/06/2006
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Last edited
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26/06/2006
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Date ISRCTN assigned
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23/06/2006
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