A comparison of azithromycin and ofloxacin in the treatment of typhoid in adult patients in Laos

ISRCTN	ISRCTN66534807
DOI	https://doi.org/10.1186/ISRCTN66534807
Protocol serial number	066828
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 066828)

Submission date: 07/12/2005
Registration date: 07/12/2005
Last edited: 02/02/2009

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Infections and Infestations

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

Contact information

Dr Paul Newton
Scientific

Microbiology laboratory
Ministry of Health
Mahosot Hospital
Mahosot Road
Vientiane
-
Lao People's Democratic Republic

Phone	+856 (0)21 250752
Email	paul@tropmedres.ac

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised clinical trial of Azithromycin versus Ofloxacin in the treatment of adults with uncomplicated typhoid fever at Mahosot Hospital, Vientiane, Lao People's Democratic Republic (PDR)
Study acronym	AO
Study objectives	To conduct an open, randomised comparative clinical trial of oral azithromycin, versus ofloxacin in the treatment of 88 adults with uncomplicated typhoid fever at Mahosot Hospital, Vientiane, Lao PDR. The primary outcome measures will be fever clearance, cure rate, relapse rate and S. typhi stool carriage rate. Trial details submitted to the Wellcome Trust 8th June 2005. Please note that as of 21/01/08 this trial was stopped. This is because the incidence of typhoid in Vientiane has declined. We have permission to continue the trial should the incidence rise or if there is an epidemic.
Ethics approval(s)	1. Oxford Tropical Ethics Committee (OXTREC) gave approval on the 6th May 2004 (ref: OXTREC 006-04) 2. Faculty of Medical Sciences, Vientiane, Laos Ethical Committee gave approval on the 2nd April 2004 (ref: FMS 2/4/2004)
Health condition(s) or problem(s) studied	Typhoid fever
Intervention	A randomised, open clinical trial with random allocation to three days ofloxacin or three days azithromycin. Please note that the anticipated end date has been extended to 31st December 2008.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Azithromycin and ofloxacin
Primary outcome measure(s)	The primary outcome measures are fever clearance, cure rate, relapse rate and S. typhi stool carriage rate.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	88
Key inclusion criteria	1. Adult (more than or equal to 15 years, either sex) non-pregnant patients with suspected or blood culture proven typhoid 2. Fever more than 37.5 °C 3. Informed written consent to the study 4. Able to stay in hospital for seven days 5. Able to take oral medication 6. Body weight more than 40 kg 7. Likely to be able to complete six months follow up 8. None of the exclusion criteria
Key exclusion criteria	1. Known hypersensitivity to ofloxacin or azithromycin 2. Administration of chloramphenicol, co-trimoxazole, ampicillin, azithromycin or a fluoroquinolone during the previous week 3. Pregnancy or breast feeding 4. Contraindications to ofloxacin or azithromycin 5. Evidence for severe typhoid
Date of first enrolment	01/05/2004
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Lao People's Democratic Republic

Study participating centre

Microbiology laboratory

Vientiane
-
Lao People's Democratic Republic

Results and Publications

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