Condition category
Infections and Infestations
Date applied
07/12/2005
Date assigned
07/12/2005
Last edited
02/02/2009
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 Paul Newton

ORCID ID

Contact details

Microbiology laboratory
Ministry of Health
Mahosot Hospital
Mahosot Road
Vientiane
-
Laos
+856 (0)21 250752
paul@tropmedres.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

066828

Study information

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)

Acronym

AO

Study hypothesis

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

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)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Azithromycin and ofloxacin

Primary outcome measures

The primary outcome measures are fever clearance, cure rate, relapse rate and S. typhi stool carriage rate.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2004

Overall trial end date

31/12/2006

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88

Participant 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

Recruitment start date

01/05/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Laos

Trial participating centre

Microbiology laboratory
Vientiane
-
Laos

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
United Kingdom

Sponsor type

University/education

Website

http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 066828)

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