An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever

ISRCTN	ISRCTN75784880
DOI	https://doi.org/10.1186/ISRCTN75784880
Protocol serial number	061330
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 061330)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Jeremy Farrar
Scientific

Oxford University Clinical Research Unit
The Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam

Phone	+84 8 8362225
Email	jfarrar@oucru.org

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DM Study
Study objectives	To determine the relative efficacy of gatifloxacin and cefixime in treating culture confirmed enteric fever
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Gatifloxacin and cefixime
Primary outcome measure(s)	Time to fever clearance
Key secondary outcome measure(s)	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
Completion date	31/12/2006
Reason abandoned (if study stopped)	Safety reasons

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	169
Key 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
Key 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
Date of first enrolment	02/06/2005
Date of final enrolment	31/12/2006

Oxford University Clinical Research Unit

Ho Chi Minh City
5
Viet Nam

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	27/06/2007		Yes	No