Condition category
Infections and Infestations
Date applied
06/06/2006
Date assigned
23/06/2006
Last edited
26/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof K.C Mohanty

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06-PLCT-CT-00037

Study information

Scientific title

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 measures

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

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

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

http://www.venusremedies.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes