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
Secondary identifying numbers 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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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 acronymAO
Study objectivesTo 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) studiedTyphoid fever
InterventionA 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Azithromycin and ofloxacin
Primary outcome measureThe primary outcome measures are fever clearance, cure rate, relapse rate and S. typhi stool carriage rate.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/05/2004
Completion date31/12/2006
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants88
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Lao People's Democratic Republic

Study participating centre

Microbiology laboratory
Vientiane
-
Lao People's Democratic Republic

Sponsor information

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan