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
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