Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2004/GD/46
Study information
Scientific title
Acronym
ASAQ
Study hypothesis
To compare treatment outcomes (clinical and parasitological) in patients with acute uncomplicated falciparum malaria treated with amodiaquine plus artesunate under a supervised and unsupervised regimens.
Ethics approval
1. Navrongo Health Research Centre Institutional Review Board. Date of approval: 26 October 2005 (ref: NHRCIRB038)
2. Ghana Health Service Ethical Review Committee. Date of approval: 30 June 2005 (ref: GHS-ERC-05/6/05)
Study design
Open-label randomized design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute malaria
Intervention
Supervised group: Each administration of artesuante and amaodiaquine will be supervised by a health professional
Unsupervised group: The participants will receive the first dose as above, but are given the reminder of the drugs for home administration
The doses are:
Artesunate (oral): 4 mg/Kilogram body weight daily for 3 days
Amodiaquine (oral): 10 mg/Kg body weight daily for 3 days
Intervention type
Drug
Phase
Not Specified
Drug names
amodiaquine , artesunate
Primary outcome measures
Adequate clinical and parasite clearance.
Timepoints of measurement: Days 2, 3, 7, 14, 21 and 28
Secondary outcome measures
Parasite and fever clearance times.
Timepoints of measurement: Days 2, 3, 7, 14, 21 and 28
Overall trial start date
01/11/2005
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Signed witnessed informed consent
2. Bodyweight >5 kg
3. P. falciparum mono-infection with parasite density of 2,000-200,000 asexual parasites per microlitre
4. Fever (axillary temperature greater than or equal to 37.5 C) and/or history of fever
5. Haemoglobin >6.0 g/dl
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
350
Participant exclusion criteria
1. Danger signs of severe malaria
2. Severe malnutrition
3. History of allergy to drugs
4. Other underlying chronic diseases
Recruitment start date
01/11/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Ghana
Trial participating centre
Navrongo Health Research Centre (NHRC)
Navrongo
-
Ghana
Sponsor information
Organisation
Ghana Health Service (Ghana)
Sponsor details
Health Research Unit
Accra
Box 114
Ghana
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Ghana-Netherlands Health Research Programme (HRP) for Development, Health Research Unit, Ghana Health Service (Ghana)
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