An open label, randomised comparative study of supervised and unsupervised amodiaquine plus artesunate treatment for acute uncomplicated Plasmodium falciparum malaria in the Kassena Nankana District of Ghana

ISRCTN	ISRCTN74716448
DOI	https://doi.org/10.1186/ISRCTN74716448
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2004/GD/46
Sponsor	Ghana Health Service (Ghana)
Funder	The Ghana-Netherlands Health Research Programme (HRP) for Development, Health Research Unit, Ghana Health Service (Ghana)

Submission date: 20/08/2007
Registration date: 29/02/2008
Last edited: 31/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Abraham Oduro
Scientific

Navrongo Health Research Centre (NHRC)
Post office box 114
Navrongo
-
Ghana

Study information

Primary study design	Interventional
Study design	Open-label randomized design.
Secondary study design	Randomised controlled trial
Scientific title	An open label, randomised comparative study of supervised and unsupervised amodiaquine plus artesunate treatment for acute uncomplicated Plasmodium falciparum malaria in the Kassena Nankana District of Ghana
Study acronym	ASAQ
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	amodiaquine , artesunate
Primary outcome measure(s)	Adequate clinical and parasite clearance. Timepoints of measurement: Days 2, 3, 7, 14, 21 and 28
Key secondary outcome measure(s)	Parasite and fever clearance times. Timepoints of measurement: Days 2, 3, 7, 14, 21 and 28
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	350
Total final enrolment	308
Key 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
Key exclusion criteria	1. Danger signs of severe malaria 2. Severe malnutrition 3. History of allergy to drugs 4. Other underlying chronic diseases
Date of first enrolment	01/11/2005
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

Ghana

Study participating centre

Navrongo Health Research Centre (NHRC)

Navrongo
-
Ghana

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008	31/05/2019	Yes	No

Editorial Notes

31/05/2019: Publication reference and total final enrolment added.