Contact information
Type
Scientific
Primary contact
Dr Nitin Rathod
ORCID ID
Contact details
Dr R N Cooper Municipal General Hospital
Ville Parle
Mumbai
400056
India
drnmrathod@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
venus/cefepime_sulbactam/082006A
Study information
Scientific title
Multicentric, open labelled, non-randomised, clinical trial to assess efficacy and safety of the fixed dose combination of cefepime and sulbactam in complicated upper and lower tract infections
Acronym
Study hypothesis
The objectives were:
1. To study the efficacy of fixed dose combination of cefepime and sulbactam injections in in complicated upper and lower tract infections
2. To assess comaprative safety of study drug
Ethics approval
Ethics approval received from the National Ethic Committee, Ahembdabad on the 28th April 2007 (date of issue of letter: 2nd May 2007) (ref: NEC/04-2007/02/VENUS/CEFEPIME_SULBACTAM/082006A).
Study design
Open labelled, non-randomised, multicentric clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Complicated upper and lower tract infections
Intervention
Fixed dose combination of cefepime and sulbactam (1.5 g to 3 g, intravenous [i.v.] twice daily). Duration of treatment 7 to 10 days, followed for 7 days after the treatment.
Intervention type
Drug
Phase
Not Specified
Drug names
Cefepime, sulbactam
Primary outcome measure
Improvement in clinical and laboratory parameters, measured on day 0, day 3 and day 7 (completion of treatment).
Secondary outcome measures
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0, day 3 and day 7 (completion of treatment).
Overall trial start date
01/05/2007
Overall trial end date
31/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants aged greater than 18 years (n = 102), either sex
2. Suffering from lower respiratory tract infections caused by gram negative organisms including pseudomonas aeruginosa
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
102
Participant exclusion criteria
1. History of hypersensitivity reaction or any specific contraindication to beta lactams
2. Presence of hepatic or renal disorders
3. Pregnancy or lactation
4. History of hearing loss
5. Alcoholics
6. Previous history seizure
Recruitment start date
01/05/2007
Recruitment end date
31/07/2007
Locations
Countries of recruitment
India
Trial participating centre
Dr R N Cooper Municipal General Hospital
Mumbai
400056
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
Basic results (scientific)
Publication list