A randomised trial to assess the efficacy of arthemeter lumifantrine and dihydroartemisinin-piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya
ISRCTN | ISRCTN36463274 |
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DOI | https://doi.org/10.1186/ISRCTN36463274 |
Secondary identifying numbers | N/A |
- Submission date
- 01/02/2007
- Registration date
- 01/02/2007
- Last edited
- 06/01/2021
- 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 P Mens
Scientific
Scientific
Royal Tropical Institute
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 566 5467 |
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p.mens@kit.nl |
Study information
Study design | Randomised, controlled, parallel group multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | A randomised trial to assess the efficacy of arthemeter lumifantrine and dihydroartemisinin-piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya |
Study objectives | Find the most effective Artemisinin-based Combination Therapy (ACT) treatment for uncomplicated falciparum malaria and the best treatment in respect to the transmission of the disease. |
Ethics approval(s) | Approval received from the Kenya Medical Research institute/National Ethical Review Committee on the 16th January 2006 (SSC protocol No.: 948). |
Health condition(s) or problem(s) studied | Malaria, Plasmodium falciparum infection |
Intervention | Two groups of 75 children meeting the inclusion criteria will be enrolled to the study and randomised to a treatment with either: 1. Lumifantrine and arthemeter, or 2. Dihydroartemisinin with piperaquine. A finger-prick blood sample for parasite detection will be taken from children presenting at the outpatient clinic with symptoms indicating uncomplicated malaria. Name of the child, father and mother, age, weight and clinical symptoms including fever are recorded at a case record form. The blood sample will be used to prepare thick and thin blood smears, and to measure haemoglobin level by using Hemocue. Blood smears will be Giemsa-stained and parasites counted against 200 White Blood Cells (WBC), with parasite negative results based on screening of 100 microscopic fields. Parasitological data are added to the patient card. Children diagnosed with uncomplicated P. falciparum malaria and meeting all inclusion/exclusion criteria will be enrolled in the drug study after explaining the purpose and procedures of the study and obtaining informed consent from the parent(s) or guardian(s). After enrolment, in the drug study an additional finger-prick blood sample will be taken to store a sample on filter paper for molecular testing by Quantitative Nucleic Acid Sequence Based Amplification (QT-NASBA). All children not included in the study will be referred back to the clinician with their patient cards for further diagnosis and treatment. They will be treated as any other outpatient and receive treatment as required. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Lumifantrine and arthemeter or dihydroartemisinin with piperaquine |
Primary outcome measure | Cured from P. falciparum infection with adequate clinical and parasitological response as defined by World Health Organisation (WHO) guidelines for clinical trials in malaria research. |
Secondary outcome measures | 1. Difference in cure rate between the different treatments 2. Effect on transmission stages (gametocytes) of the parasite |
Overall study start date | 01/03/2007 |
Completion date | 01/03/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 6 Months |
Upper age limit | 12 Years |
Sex | Both |
Target number of participants | 150 |
Total final enrolment | 146 |
Key inclusion criteria | 1. Age six months to 12 years 2. Resident in research area and able to complete follow up 3. Temperature higher than 37.5°C but lower than 39.5°C or history of fever in last 24 hours 4. Understanding the procedures of the study by parents or guardian (informed consent) 5. Diagnosed with uncomplicated malaria (P. falciparum) only 6. Parasitaemia 100 - 100.000 parasites/ul |
Key exclusion criteria | 1. General danger signs, severe malaria or severe anaemia 2. Severe malnutrition 3. Presence of diseases other than malaria causing febrile conditions 4. Unwilling to participate and sign informed consent form |
Date of first enrolment | 01/03/2007 |
Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- Kenya
- Netherlands
Study participating centre
Royal Tropical Institute
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Royal Tropical Institute (KIT) (The Netherlands)
Research organisation
Research organisation
Bio-Medical Research
Meibergdreef 39
Amsterdam
1105 AZ
Netherlands
Website | http://www.kit.nl/ |
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https://ror.org/01z6bgg93 |
Funders
Funder type
Research organisation
Royal Tropical Institute (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 18/11/2008 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: Publication reference and total final enrolment added.