Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
11/03/2013
Prospective/Retrospective
Prospectively 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 Jeremy Farrar

ORCID ID

Contact details

Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 88362225
jfarrar@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

061330

Study information

Scientific title

Acronym

BJ Study

Study hypothesis

There has been a dramatic change in Viet Nam in the sensitivity of Salmonella typhi (the bacteria that causes typhoid fever) to all antibiotics. In the Mekong Delta more than 95% of isolates are resistant to all first line antibiotics (defined as multidrug resistant) and show significantly poorer clinical response to the older fluoroquinolones. There is the very real risk that typhoid fever in Viet Nam will soon become effectively untreatable. There is an urgent need to develop treatments that combine speed of clinical response, reduction in secondary transmission and protection from the development of resistance. From uncontrolled clinical data from a small number of patients treated at Dong Thap Hospital in Viet Nam and from in vitro sensitivity data gatifloxacin maybe a suitable new treatment for multidrug resistant Typhoid Fever.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Typhoid fever

Intervention

An open randomised two-way comparison of gatifloxacin (10 mg/kg/day) versus azithromycin (20 mg/kg/day) for seven days for the treatment of symptomatic uncomplicated typhoid fever.

Intervention type

Drug

Phase

Not Specified

Drug names

Gatifloxacin and azithromycin

Primary outcome measures

Fever Clearance Time.

Secondary outcome measures

Clinical and Microbiological Failure.

Overall trial start date

01/10/2005

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be eligible if they have suspected or culture proven enteric fever provided:
1. They give fully informed consent
2. They are not obtunded not jaundiced
3. There are no signs of gastrointestinal (GI) bleeding or any other evidence of severity (see below)
4. No history of hypersensitivity to either of the trial drugs
5. No treatment with a quinolone or 3rd generation cephalosporin or macrolide within one week of hospital admission
6. They are not pregnant

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

To be added

Participant exclusion criteria

1. Pregnancy or lactation
2. Any signs of symptoms of severe disease
3. No informed consent

Recruitment start date

01/10/2005

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 061330)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18493312

Publication citations

  1. Results

    Dolecek C, Tran TP, Nguyen NR, Le TP, Ha V, Phung QT, Doan CD, Nguyen TB, Duong TL, Luong BH, Nguyen TB, Nguyen TA, Pham ND, Mai NL, Phan VB, Vo AH, Nguyen VM, Tran TT, Tran TC, Schultsz C, Dunstan SJ, Stepniewska K, Campbell JI, To SD, Basnyat B, Nguyen VV, Nguyen VS, Nguyen TC, Tran TH, Farrar J, A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam., PLoS ONE, 2008, 3, 5, e2188, doi: 10.1371/journal.pone.0002188.

Additional files

Editorial Notes