Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A60100
Study information
Scientific title
Acronym
Study hypothesis
The effectiveness of Coartem® would be equal to efficacy given good compliance.
Ethics approval
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).
Study design
Clinical research
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2007
Overall trial end date
01/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
360
Participant 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
Recruitment start date
01/03/2007
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Tanzania
Trial participating centre
Manager
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Multilateral Initiative on Malaria (MIM)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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)
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21427394
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23506218?
Publication citations
-
Results
Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, Bergqvist Y, Gil JP, Premji Z, Björkman A, Mårtensson A, Efficacy and effectiveness of artemether-lumefantrine after initial and repeated treatment in children <5 years of age with acute uncomplicated Plasmodium falciparum malaria in rural Tanzania: a randomized trial., Clin. Infect. Dis., 2011, 52, 7, 873-882, doi: 10.1093/cid/cir066.
-
Malmberg M, Ngasala B, Ferreira PE, Larsson E, Jovel I, Hjalmarsson A, Petzold M, Premji Z, Gil JP, Björkman A, Mårtensson A, Temporal trends of molecular markers associated with artemether-lumefantrine tolerance/resistance in Bagamoyo district, Tanzania., Malar. J., 2013, 12, 103, doi: 10.1186/1475-2875-12-103.