Safety and efficacy of a fixed dose combination of cefepime and amikacin

ISRCTN	ISRCTN61799591
DOI	https://doi.org/10.1186/ISRCTN61799591
Secondary identifying numbers	Nex/VR/CT_PMS_089/01_2007

Submission date: 04/03/2008
Registration date: 15/05/2008
Last edited: 15/05/2008

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tanuraj Sirohi
Scientific

Subharti Medical College
Merrut, UP
250002
India

Email	tsirohi@yahoo.com

Study information

Study design	Open labelled, randomised, multicentric clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	To evaluate efficacy of fixed dose combination of cefepime-amikacin in various infections.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cefepime-amikacin
Primary outcome measure	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 study start date	28/04/2007
Completion date	14/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	315
Key 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)
Key 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
Date of first enrolment	28/04/2007
Date of final enrolment	14/09/2007

Locations

Countries of recruitment

India

Study participating centre

Subharti Medical College

Merrut, UP
250002
India

Sponsor information

Venus Remedies Limited (India)
Industry

51-52 Industrial Area
Phase- I
Panchkula, Haryana
134113
India

Email	research@venusremedies.com
Website	http://www.venusremedies.com
"ROR"	https://ror.org/0169rv113

Funders

Funder type

Industry

Venus Remedies Limited (India)

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