Efficacy and safety of the fixed dose combination of cefepime and sulbactam

ISRCTN	ISRCTN84455313
DOI	https://doi.org/10.1186/ISRCTN84455313
Secondary identifying numbers	venus/cefepime_sulbactam/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, non-randomised, multicentric clinical trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 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	102
Key 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
Key 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
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 - 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