Condition category
Infections and Infestations
Date applied
20/08/2007
Date assigned
29/02/2008
Last edited
29/02/2008
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 Abraham Oduro

ORCID ID

Contact details

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

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

http://www.ghanahealthservice.org/

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

Publication citations

Additional files

Editorial Notes