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

ISRCTN	ISRCTN65171867
DOI	https://doi.org/10.1186/ISRCTN65171867
Secondary identifying numbers	06-PLCT-CT-00037

Submission date: 06/06/2006
Registration date: 23/06/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof K.C Mohanty
Scientific

Professor and Head
K.J.Somaiya Medical Hospital and Research Centre
Department of Chest Medicine
Mumbai
400022
India

Study information

Study design	Open-labeled, randomized controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Multicentric, randomized, comparative, open-labeled trial of a fixed dose combination of cefepime and amikacin versus cefepime alone in nosocomial pneumonia
Study acronym	RCCT
Study objectives	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(s)	Approval given by Institutional Ethics Committee, reference number: Ct/ca/01
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/11/2005
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Total final enrolment	200
Key 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
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

India

Study participating centre

Professor and Head

Mumbai
400022
India

Sponsor information

Venus Remedies Limited (India)
Industry

Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India

Phone	+91 17 22561244
Email	operations@venusremedies.com
Website	http://www.venusremedies.com
"ROR"	https://ror.org/0169rv113

Funders

Funder type

Industry

Venus Remedies Limited

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.