To assess the efficacy and tolerability of three antimalarial treatments in The Democratic Republic of Congo (DRC)
ISRCTN | ISRCTN20984426 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN20984426 |
Secondary identifying numbers | Version # 1.01 30 March 2011 |
- Submission date
- 22/09/2011
- Registration date
- 06/10/2011
- Last edited
- 10/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Malaria is a serious tropical disease spread by mosquitoes. Antimalarial medication is used to prevent and treat malaria, with the first-line treatment being the first treatment given. We are carrying out a detailed assessment of the effectiveness of the current first-line antimalarial treatment, 5 years after its introduction. We will also assess the effectiveness of two other antimalarial treatments which could replace the first line in the near future, or be proposed as first-line treatment as part of a multiple first-line treatment strategy.
Who can participate?
Children aged 6 to 59 months with uncomplicated malaria
What does the study involve?
Participants are randomly allocated to one of the three treatments. The three treatments are amodiaquine-artesunate, dihydroartemisinin-piperaquine and artemether-lumefantrine. The study is open label, so the doctor and the patients both know which treatment they have been assigned to. All children are hospitalized for four days and given supervised treatment. The effectiveness of the treatment is measured and participants are followed up for 42 days after treatment.
What are the possible benefits and risks of participating?
The results of the study will enable the Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated, and offer possible alternatives.
Where is the study run from?
The study will be conducted in Kinshasa, Democratic Republic of Congo.
When is the study starting and how long is it expected to run for?
September 2011 to December 2012
Who is funding the study?
Oxford University (UK)
Who is the main contact?
Prof Nick PJ Day
Contact information
Scientific
Faculty of Tropical Medicine
Mahidol University
3rd Floor
60th Anniversary Chalermprakiat Building
420/6 Rajwithi Road
Bangkok
10400
Thailand
Study information
Study design | Randomised three-arm open study |
---|---|
Primary study design | Interventional |
Secondary study design | 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 | A randomised study to assess the efficacy and tolerability of three Artemisinin-based combination therapy (ACT) in The Democratic Republic of Congo (DRC) |
Study objectives | This study will assess the efficacy of amodiaquine-artesunate for the treatment of uncomplicated P. falciparum malaria in children in Kinshasa, DRC, five years after its introduction as a first line treatment, and compare this with the efficacies of dihydroartemisinin-piperaquine and artemether-lumefantrine. |
Ethics approval(s) | 1. Oxford Tropical Research Ethics Committee (OXTREC), 06/04/2011 2. Ethics Committee of Kinshasa University, Ministry of Higher Education and University, Democratic Republic of Congo (Ministère de I'Enseignement Supérieur et Universitaire, République Démocratique du Congo), 21/04/2011 |
Health condition(s) or problem(s) studied | Malaria |
Intervention | This is a randomised, open study, comparing three ACTs, dihydroartemisinin-piperaquine (DHA-PQ), artemetherlumefantrine (ALN) and amodiaquine-artesunate coformulated (AQ-AS), for the treatment of symptomatic uncomplicated falciparum malaria. The study is post-marketing, all three study drugs are in fact commercialized and used worldwide. Our aim is to monitor their efficacy and tolerability in this particular geographical area. Dosage and length of treatment are according to manufacturer. Children aged 6 to 59 months with uncomplicated P. falciparum malaria are randomly assigned to one of the three arms. All children are hospitalized for 3 days and given supervised treatment. Treatment efficacy is measured according to WHO (Methods for surveillance of antimalarial drug, WHO 2009). Patients are followed-up actively weekly for 42 days after treatment. Treatment allocation is concealed until recruitment is confirmed and the laboratory technicians reading all malaria smears have no knowledge of the treatment received by individual patients. Randomisation is in blocks of 15. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Amodiaquine-artesunate, dihydroartemisinin-piperaquine, artemether-lumefantrine |
Primary outcome measure | 1. Clinical and parasitological cure by day 42 post-treatment 2. Treatment tolerability |
Secondary outcome measures | 1. The median parasite clearance time (PCT) 3. Fever clearance time (FCT) |
Overall study start date | 08/09/2011 |
Completion date | 31/12/2012 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Neonate |
Sex | Both |
Target number of participants | 684 |
Key inclusion criteria | 1. Children aged 3 to 59 months 2. Weight ≥ 5 kg [the minimum weight for treatment with artemether-lumefantrine (ALN)] 3. Mono-infection with P. falciparum 4. Parasitaemia of ≥2,000 and ≤200,000 asexual parasites per µL 5. Axillary temperature 37.5 °C or history of fever in the preceding 24 hrs 6. Ability to swallow oral medication 7. Haemoglobin ≥5.0 g/dL 8. Parents/guardians agree to hospitalize the child for the length of treatment (34 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42 9. Signed consent from guardian / parents |
Key exclusion criteria | 1. Danger signs of severe malaria or signs of severe malaria (WHO 2000) 2. Children with severe malnutrition, marasmus or oedematous malnutrition (WHO 2006) 3. Febrile condition due to diseases other than malaria [e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, human immunodeficiency virus (HIV) / acquired immune deficiency syndrome (AIDS)] 4. History of hypersensitivity reactions or contraindication to any medicine being tested 5. A clear history of adequate antimalarial treatment in the preceding 72 hours with drugs expected to be effective 6. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV positive women |
Date of first enrolment | 08/09/2011 |
Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Congo, Democratic Republic
- Thailand
Study participating centre
10400
Thailand
Sponsor information
University/education
CCVTM
Churchill Hospital
University of Oxford
Oxford
OX3 7LJ
England
United Kingdom
nickd@tropmedres.ac | |
Website | http://www.tropmedres.ac/ |
https://ror.org/052gg0110 |
Funders
Funder type
University/education
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 | 01/09/2014 | Yes | No |
Editorial Notes
10/02/2016: Plain English summary added
On 13/12/2012 the overall trial end date was changed from 08/09/2012 to 31/12/2012.