Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06-PLCT-CT-00037
Study information
Scientific title
Multicentric, randomized, comparative, open-labeled trial of a fixed dose combination of cefepime and amikacin versus cefepime alone in nosocomial pneumonia
Acronym
RCCT
Study hypothesis
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.
Ethics approval
Approval given by Institutional Ethics Committee, reference number: Ct/ca/01
Study design
Open-labeled, randomized controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nosocomial pneumonia
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
cefepime, amikacin
Primary outcome measure
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
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.
Overall trial start date
01/11/2005
Overall trial end date
31/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Total final enrolment
200
Participant 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
Recruitment start date
01/11/2005
Recruitment end date
31/03/2006
Locations
Countries of recruitment
India
Trial participating centre
Professor and Head
Mumbai
400022
India
Sponsor information
Organisation
Venus Remedies Limited (India)
Sponsor details
Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
+91 17 22561244
operations@venusremedies.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Venus Remedies Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in https://pubmed.ncbi.nlm.nih.gov/18700304/ (added 08/01/2021)