Contact information
Type
Scientific
Primary contact
Dr P Mens
ORCID ID
Contact details
Royal Tropical Institute
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 5467
p.mens@kit.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
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
01/03/2007
Overall trial end date
01/03/2008
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Child
Gender
Both
Target number of participants
150
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
01/03/2007
Recruitment end date
01/03/2008
Locations
Countries of recruitment
Kenya
Trial participating centre
Royal Tropical Institute
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Royal Tropical Institute (KIT) (The Netherlands)
Sponsor details
Bio-Medical Research
Meibergdreef 39
Amsterdam
1105 AZ
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Royal Tropical Institute (The Netherlands)
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
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
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17018138
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) 3541
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15279949
Publication citations
-
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.
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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.