Ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections

ISRCTN	ISRCTN69844323
DOI	https://doi.org/10.1186/ISRCTN69844323
Secondary identifying numbers	venus/ceftazidime_tobramycin/082006A

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 Nitin Rathod
Scientific

Dr R N Cooper Municipal General Hospital
Ville Parle
Mumbai
400056
India

Email	drnmrathod@hotmail.com

Study information

Study design	Open labelled, comparative, randomised, multicentric clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Comparative efficacy and synergy establishment of ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ceftazidime tobramycin fixed drug combination (FDC), ceftazidime alone
Primary outcome measure	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 study start date	01/05/2007
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	240
Key inclusion criteria	1. Participants aged greater than 18 years (n = 240), either sex 2. Hopsitalised patients suffering from lower respiratory tract infections
Key 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
Date of first enrolment	01/05/2007
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

India

Study participating centre

Dr R N Cooper Municipal General Hospital

Mumbai
400056
India

Sponsor information

Venus Remedies Limited (India)
Industry

51 - 52 Industrial Area
Phase - 1
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