Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
11/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jeremy Farrar

ORCID ID

Contact details

Oxford University Clinical Research Unit
The Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 8 8362225
jfarrar@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

061330

Study information

Scientific title

Acronym

DM Study

Study hypothesis

To determine the relative efficacy of gatifloxacin and cefixime in treating culture confirmed enteric 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

Enteric fever

Intervention

Open label randomised controlled trial of gatifloxacin versus cefixime.

Please note that due to safety reasons this trial was terminated on the 8th September 2005.

Intervention type

Drug

Phase

Not Specified

Drug names

Gatifloxacin and cefixime

Primary outcome measures

Time to fever clearance

Secondary outcome measures

1. Development of complications
2. Blood culture sterilisation
3. Eradication of stool carriage
4. Need for retreatment
5. Development of enteric fever in household contacts
6. Treatment failure

Overall trial start date

02/06/2005

Overall trial end date

31/12/2006

Reason abandoned

Safety reasons

Eligibility

Participant inclusion criteria

1. The treating physician believes the diagnosis to be enteric fever
2. More than or equal to three days history of fever, headache and oral temperature more than or equal to 37.8 °C

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

169

Participant exclusion criteria

1. Complicated typhoid (jaundice, shock, peritonism, gastrointestinal bleeding, myocarditis, encephalopathy)
2. Pregnancy
3. Lactation
4. Allergy to study drug
5. Quinolone, fluoroquinolone, macrolide or 3rd generation cephalosporin treatment within previous week
6. Unable to take oral medication

Recruitment start date

02/06/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Nepal

Trial participating centre

Oxford University Clinical Research Unit
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: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17593957

Publication citations

  1. Results

    Pandit A, Arjyal A, Day JN, Paudyal B, Dangol S, Zimmerman MD, Yadav B, Stepniewska K, Campbell JI, Dolecek C, Farrar JJ, Basnyat B, An open randomized comparison of gatifloxacin versus cefixime for the treatment of uncomplicated enteric fever., PLoS ONE, 2007, 2, 6, e542, doi: 10.1371/journal.pone.0000542.

Additional files

Editorial Notes