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/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

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