A randomized trail to asses the efficacy of Arthemeter Lumifantrine and Dihydroartemisinin -piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR864
• Date of registration: 03/01/2007
• Primary sponsor: Royal Tropical Institute (KIT), Bio-Medical Research
• Public title: A randomized trail to asses the efficacy of Arthemeter Lumifantrine and Dihydroartemisinin -piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya
• Scientific title: A randomized trail to asses the efficacy of Arthemeter Lumifantrine and Dihydroartemisinin -piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya - N/A
• Date of first enrolment: 1/3/2007
• Target sample size: 150
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=864
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: P. Mens

• Name: P. Mens

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age six to 12 years;
2. Resident in research area and able to comlete follow up;
3. Temperature higher than 37.5 degrees but lower than 39.5 degrees 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
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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Malaria, Plasmodium falciparum infection

Intervention(s)

Two groups of 75 children meeting the inclusion critera will be enroled to the study and randomized to a treatment with either Lumifantrine and Athemeter or Dihydroartemisinin with Piperaquine. A fingerprick 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 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 fingerprick blood sample will be taken to store a sample on filter paper for molecular testing by 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.

Primary Outcome(s)

Cured from P. falciparum infection with addequate clinical and parasitological respone as defined by WHO guidlines for clinical trails in malaria research.

Secondary Outcome(s)

1. Difference in cure rate between the different treatments;
2. Effect on transmission stages (gametocytes) of the parasite.

Secondary ID(s)

ISRCTN36463274

N/A

Source(s) of Monetary Support

Royal Tropical Institute, Knowledge and innovation fund, St. Dioraphte

Secondary Sponsor(s)

Academic Medical Centre (AMC), Devision for Tropical Medicine and AIDS

Kenya Medical Research institute, Centre for Biotechnology research and Development