Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr P Mens


Contact details

Royal Tropical Institute
1105 AZ
+31 (0)20 566 5467

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

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

Approval received from the Kenya Medical Research institute/National Ethical Review Committee on the 16th January 2006 (SSC protocol No.: 948).

Study design

Randomised, controlled, parallel group multicentre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Malaria, Plasmodium falciparum infection


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Royal Tropical Institute
1105 AZ

Sponsor information


Royal Tropical Institute (KIT) (The Netherlands)

Sponsor details

Bio-Medical Research
Meibergdreef 39
1105 AZ

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Royal Tropical Institute (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Mens, P.F., Schoone, G.J., Kager, P.A. & Schallig, H.D.F.H. (2006). Detection and Identification of human Plasmodium species with real-time quantitative nucleic acid sequence based amplification. Malaria Journal 5, 80

Petra Schneider, Gerard Schoone, Henk Schallig , Danielle Verhage ,Denise Telgt, Wijnand Eling, Robert Sauerwein Quantification of Plasmodium falciparum gametocytes in differential stages of development by quantitative nucleic acid sequence-based amplification Molecular & Biochemical Parasitology 137 (2004) 35–41

Publication citations

  1. Mens PF, Schoone GJ, Kager PA, Schallig HD, Detection and identification of human Plasmodium species with real-time quantitative nucleic acid sequence-based amplification., Malar. J., 2006, 5, 80, doi: 10.1186/1475-2875-5-80.

  2. Schneider P, Schoone G, Schallig H, Verhage D, Telgt D, Eling W, Sauerwein R, Quantification of Plasmodium falciparum gametocytes in differential stages of development by quantitative nucleic acid sequence-based amplification., Mol. Biochem. Parasitol., 2004, 137, 1, 35-41, doi: 10.1016/j.molbiopara.2004.03.018.

Additional files

Editorial Notes