Treatment of uncomplicated childhood malaria by artemether-lumefantrine (Coartem®) efficacy, effectiveness, safety and genotyping in Tanzania
| ISRCTN | ISRCTN69189899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69189899 |
| Secondary identifying numbers | A60100 |
- Submission date
- 17/04/2007
- Registration date
- 03/05/2007
- Last edited
- 22/03/2013
- 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 Olumide Ogundahunsi
Scientific
Scientific
Manager
MIM/TDR Task Force on Malaria Research Capability Strengthening in Africa
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Study design | Clinical research |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The effectiveness of Coartem® would be equal to efficacy given good compliance. |
| Ethics approval(s) | Approval received from the ethics board of the National Institute of Medical Research Board on the 1st August 2006 (ref: NIMR/HQ/R.8a/Vol. IX/344). |
| Health condition(s) or problem(s) studied | Malaria in under five children |
| Intervention | In this clinical trial there is no intervention apart from early diagnosis and prompt treatment. Patients will be treated with Artemether-lumefantrine (Coartem®), given either under supervision or by their parents. Treatment with Coartem® will be for three days, and the patients will be followed up on the following days: Under supervision: follow-up on days 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56 Drugs given by parent: follow-up on days 1, 7, 14, 21, 2, 35, 42, 49, 56 If the treatment is a clinical failure after day 14, or a parasitological failure after day 56, then the patient will again be treated for three days with Coartem®, and will be followed up on the following days: Under supervision: follow-up on days 1, 2, 3, 7, 14, 21, 28, 35, 42 Drugs given by parent: follow-up on days 1, 7, 14, 21, 2, 35, 42 If the treatment is a clinical failure after day 14, or a parasitological failure after day 42, then the patient is treated with quinine. Principal Investigator: Professor Zul Premji Muhimbili University College of Health Sciences Box 65011 Dar es Salaam United Republic of Tanzania Tel: +255 (0)754 304 468 Email: zpremji@muchs.ac.tz |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artemether-lumefantrine (Coartem®) |
| Primary outcome measure | Polymerase Chain Reaction (PCR)-adjusted parasitological treatment response (cure, treatment failure) on days 14, 28, 42 and 56 after initial treatment, and on days 14, 28 and 42 after retreatment in supervised and unsupervised patients. |
| Secondary outcome measures | 1. Occurrence of adverse events during 56 and 42 days after initial and retreatment 2. Recrudescence after initial and retreatment 3. Reinfection after initial treatment |
| Overall study start date | 01/03/2007 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 360 |
| Key inclusion criteria | 1. Males or females less than five years of age with body weight greater than 5 kg 2. Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 2,000 to 200,000 parasites/µl 3. Presenting with fever (axillary temperature equal to 37.5°C) or having a history of fever in the preceding 24 hours 4. Able to ingest tablets orally (either suspended in water or un-crushed with food) |
| Key exclusion criteria | 1. Present with any of the danger signs of severe malaria 2. Signs/symptoms indicating severe/complicated malaria according to World Health Organization (WHO) criteria (WHO definition) 3. Serious gastrointestinal disease, severe malnutrition (Weight-for-Height [W/H] less than 70%) or severe anaemia (haemoglobin less than 5 g/dl) 4. Known hypersensitivity to artemether-lumefantrine 5. Have been treated with any other drugs within eight weeks prior to screening or intend to use other drugs or biologics during the study |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
Study participating centre
Manager
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/tdr/diseases/malaria/mim.htm |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
Multilateral Initiative on Malaria (MIM)
No information available
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
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 | 01/04/2011 | Yes | No | |
| Results article | results | 18/03/2013 | Yes | No |
