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 |
| Secondary identifying numbers | 2004/GD/46 |
- 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
Scientific
Navrongo Health Research Centre (NHRC)
Post office box 114
Navrongo
-
Ghana
Study information
| Study design | Open-label randomized design. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | amodiaquine , artesunate |
| Primary outcome measure | 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 study start date | 01/11/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
-
Ghana
Sponsor information
Ghana Health Service (Ghana)
Government
Government
Health Research Unit
Accra
Box 114
Ghana
| Website | http://www.ghanahealthservice.org/ |
|---|---|
"ROR" |
https://ror.org/052ss8w32 |
Funders
Funder type
Government
The Ghana-Netherlands Health Research Programme (HRP) for Development, Health Research Unit, Ghana Health Service (Ghana)
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 |
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.
