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/ceftazidime_tobramycin/082006A
Study information
Scientific title
Comparative efficacy and synergy establishment of ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections
Acronym
Study hypothesis
1. To assess efficacy of ceftazidime tobramycin fixed drug combination (FDC) in comparison with ceftazidime monotherapy in lower respiratory tract infections
2. To assess comparative safety of study drugs
Ethics approval
Ethics approval received from the National Ethic Committee, Ahemdabad on the 28th April 2007 (date of issue of letter: 2nd May 2007) (ref: NEC/04-2007/01/VENUS/TOBCEF/082006A).
Study design
Open labelled, comparative, randomised, multicentric clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lower respiratory tract infections
Intervention
1. Ceftazidime (1 g) and tobramycin (120 mg) fixed drug combination (FDC), eight-hourly, intravenous (i.v.) for seven days
2. Ceftazidime (1 g), eight-hourly, i.v. for seven days
Intervention type
Drug
Phase
Not Specified
Drug names
Ceftazidime tobramycin fixed drug combination (FDC), ceftazidime alone
Primary outcome measures
Improvement in clinical and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the treatment.
Secondary outcome measures
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the treatment.
Overall trial start date
01/05/2007
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Participants aged greater than 18 years (n = 240), either sex
2. Hopsitalised patients suffering from lower respiratory tract infections
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Patients having received antibiotic treatment within two weeks of therapy
2. History of hypersensitivity reaction or any specific contraindication to beta lactams
3. Presence of hepatic or renal disorders
4. Pregnancy or lactation
5. History of hearing loss
6. Alcoholics
7. 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 - 1
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