Condition category
Infections and Infestations
Date applied
04/03/2008
Date assigned
15/05/2008
Last edited
15/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.venusremedies.com

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

Publication citations

Additional files

Editorial Notes