Condition category
Infections and Infestations
Date applied
04/03/2008
Date assigned
15/05/2008
Last edited
15/05/2008
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

Dr Tanuraj Sirohi

ORCID ID

Contact details

Subharti Medical College
Merrut
UP
250002
India
tsirohi@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Nex/VR/CT_PMS_089/01_2007

Study information

Scientific title

An open labelled post marketing surveillance study to evaluate safety and efficacy of a fixed dose combination of cefepime and amikacin in subjects with mild to severe infections

Acronym

Study hypothesis

To evaluate efficacy of fixed dose combination of cefepime-amikacin in various infections.

Ethics approval

Ethics approval received from:
1. Independent Ethic Committee for Clinical Research, New Delhi on the 11th April 2007 (ref: IEC/Nex/VR//CT-PMS/08901-2007)
2. Ethic Committee, SP Medical College and Associated Hospitals, Bikaner on the 16th July 2008 (ref: SP-EC//Nex/VR//CT-PMS/08901-2007)

Study design

Open labelled, randomised, multicentric clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nosocomial pneumonia, febrile neutropenia, other bacterial infections

Intervention

The subjects were divided in three groups as per the severity of the infection:
1. Group A (severely infected) were given 2.5 g twice daily (BD) of cefepime-amikacin fixed dose combination (FDC)
2. Group B (moderately infected) were given 1.25 g BD of cefepime-amikacin FDC
3. Group C (mildly infected) were given 0.625 g BD of cefepime-amikacin FDC

Total duration of therapy 3 - 10 days, followed up for 7 days after the treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

Cefepime-amikacin

Primary outcome measures

Improvement in clinical and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT).

Secondary outcome measures

To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT).

Overall trial start date

28/04/2007

Overall trial end date

14/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hospitalised patients of either sex
2. Above 18 years of age
3. Clinically diagnosed subjects with moderate to severe infections of:
3.1. Febrile neutropenia (n = 110)
3.2. Nosocomial pneumonia (n = 110)
3.3. Other bacterial infection (n = 91)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

315

Participant exclusion criteria

1. History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs
2. Hepatic or renal disorder or any heart disorder
3. Pregnancy and/or lactation
4. History of hearing loss
5. Alcoholics

Recruitment start date

28/04/2007

Recruitment end date

14/09/2007

Locations

Countries of recruitment

India

Trial participating centre

Subharti Medical College
Merrut, UP
250002
India

Sponsor information

Organisation

Venus Remedies Limited (India)

Sponsor details

51-52 Industrial Area
Phase- I
Panchkula
Haryana
134113
India
research@venusremedies.com

Sponsor type

Industry

Website

http://www.venusremedies.com

Funders

Funder type

Industry

Funder name

Venus Remedies Limited (India)

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