Condition category
Infections and Infestations
Date applied
22/01/2008
Date assigned
23/01/2008
Last edited
02/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
Mahosot Hospital
Vientiane
-
Laos
paul@tropmedres.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LMC-11

Study information

Scientific title

An assessment of the efficacy of oral chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Savannakhet Province, Lao People's Democratic Republic (PDR)

Acronym

LVT

Study hypothesis

That oral chloroquine remains efficacious in the treatment of Plasmodium vivax malaria in southern Laos.

Ethics approval

Ethics approval received from:
1. Oxford Tropical Research Ethics Committee (OXTREC) (UK) on the 24th May 2005
2. National Ethic Committee for Health Research (NECHR) (Lao PDR) on the 24th May 2005

Study design

A pilot single arm efficacy study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Vivax malaria

Intervention

Oral chloroquine 25 mg base/kg over 3 days (10 mg base/kg stat, followed by 10 mg base/kg at 24 hours later, followed by 5 mg base/kg at 48 hours).

Total duration of follow-up is 42 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Chloroquine

Primary outcome measures

Cure rate.

Outcomes measured daily until parasite clearance and then weekly until 42 days post treatment.

Secondary outcome measures

1. Parasite clearance time
2. Fever clearance time

Outcomes measured daily until parasite clearance and then weekly until 42 days post treatment.

Overall trial start date

01/06/2005

Overall trial end date

30/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent from patient or attending relative
2. Age greater than 1 year old, either sex
3. P. vivax infection (greater than 500 asexual stages/μL)
4. Acute uncomplicated malaria (World Health Organization [WHO] 2000)
5. Axillary temperature greater than 37.5°C
6. No full course of antimalarial treatment in the previous 3 days
7. High probability that patient will be able to complete 42 days follow up

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Inability or unwillingness to give informed consent
2. Mixed species malaria infections
3. Severe malaria (WHO, 2000)
4. History of allergy to chloroquine
5. Asymptomatic malaria
6. Low probability of 42 days follow up

Recruitment start date

01/06/2005

Recruitment end date

30/12/2010

Locations

Countries of recruitment

Laos

Trial participating centre

Microbiology Laboratory
Vientiane
-
Laos

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ccvtm.ox.ac.uk/

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