Condition category
Infections and Infestations
Date applied
08/06/2006
Date assigned
23/06/2006
Last edited
23/06/2006
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 Milind Khadke

ORCID ID

Contact details

Manas Chest Clinic
301 Marathon Chambers
P.K. Road
Paanchrasta
Mulund (W)
Mumbai
400022
India
milind_khadke@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT/CS/01

Study information

Scientific title

Acronym

Study hypothesis

The increasing rate of the resistance of antibacterials in lower respiratory tract infection (LRTI) pathogens has resulted in the need to consider innovative approaches like combining β-lactam antibiotics with β-lactamase inhibitors. The presence of sulbactam in fixed-dose combination (FDC) along with ceftriaxone could extend the antibiotic spectrum of ceftriaxone to include bacteria normally resistant to it. The aim of our study was to evaluate the efficacy and safety of ceftriaxone and sulbactam in fixed-dose combination in the treatment of lower respiratory tract infection.

Ethics approval

Independent institutional ethics committee approval of participating centres were taken before initiation, reference number: CT/CS/01

Study design

Open-label, non-comparative, multicentric study

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Lower respiratory tract infection

Intervention

Treatment consisted of 1 g ceftriaxone + 0.5 g sulbactam in intravenous fixed dose combination every eight hours for 7 -10 days

Intervention type

Drug

Phase

Not Specified

Drug names

Ceftriaxone, sulbactam

Primary outcome measures

The overall efficacy of fixed dose combination (FDC) of ceftriaxone and sulbactam was excellent. The clinical cure rate was 77.14% and the bacteriological cure rate was 100%. A total of three adverse reactions were noted in 12 of the 105 patients receiving ceftriaxone and sulbactam (FDC) but none of them warranted discontinuation of treatment. Adverse effects noted included: pain at the injection site (5.7%), superficial thrombophlebitis (4.76%), and mild diarrhea (0.95%).

Secondary outcome measures

Ceftriaxone and sulbactam in fixed dose combination (FDC) is an effective and well-tolerated antimicrobial agent that appears promising for the treatment of serious lower respiratory tract infections

Overall trial start date

01/04/2005

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥18 years
2. Fever ≥38°C
3. Sputum pus cells >25 high power fields (HPF)
4. Buccal epithelial cells <10 HPF

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

105

Participant exclusion criteria

1. Hypersensitivity to ceftriaxone, sulbactam or related drugs
2. Children less than 18 years of age
3. Septicemic shock, active pulmonary malignancies, renal and hepatic insufficiencies

Recruitment start date

01/04/2005

Recruitment end date

30/09/2005

Locations

Countries of recruitment

India

Trial participating centre

Manas Chest Clinic
Mumbai
400022
India

Sponsor information

Organisation

Venus Remedies Limited (India)

Sponsor details

Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
+91 17 22561244
operations@venusremedies.com

Sponsor type

Industry

Website

http://www.venusremedies.com

Funders

Funder type

Industry

Funder name

Venus Remedies Limited

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