The efficacy of chloroquine in treatment of vivax malaria in southern Laos

ISRCTN	ISRCTN17027907
DOI	https://doi.org/10.1186/ISRCTN17027907
Secondary identifying numbers	LMC-11

Submission date: 22/01/2008
Registration date: 23/01/2008
Last edited: 02/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
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
Mahosot Hospital
Vientiane
-
Lao People's Democratic Republic

Email	paul@tropmedres.ac

Study information

Study design	A pilot single arm efficacy study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
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)
Study acronym	LVT
Study objectives	That oral chloroquine remains efficacious in the treatment of Plasmodium vivax malaria in southern Laos.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Chloroquine
Primary outcome measure	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 study start date	01/06/2005
Completion date	30/12/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/06/2005
Date of final enrolment	30/12/2010

Locations

Countries of recruitment

Lao People's Democratic Republic

Study participating centre

Microbiology Laboratory

Vientiane
-
Lao People's Democratic Republic

Sponsor information

University of Oxford (UK)
University/education

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Churchill Hospital
Oxford
OX3 7LJ
England
United Kingdom

Email	research.services@admin.ox.ac.uk
Website	http://www.ccvtm.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan