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
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

Royal Tropical Institute
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 566 5467
Email p.mens@kit.nl

Study information

Study designRandomised, controlled, parallel group multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA 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 objectivesFind 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) studiedMalaria, Plasmodium falciparum infection
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Lumifantrine and arthemeter or dihydroartemisinin with piperaquine
Primary outcome measureCured 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 measures1. Difference in cure rate between the different treatments
2. Effect on transmission stages (gametocytes) of the parasite
Overall study start date01/03/2007
Completion date01/03/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit12 Years
SexBoth
Target number of participants150
Total final enrolment146
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2007
Date of final enrolment01/03/2008

Locations

Countries of recruitment

  • Kenya
  • Netherlands

Study participating centre

Royal Tropical Institute
Amsterdam
1105 AZ
Netherlands

Sponsor information

Royal Tropical Institute (KIT) (The Netherlands)
Research organisation

Bio-Medical Research
Meibergdreef 39
Amsterdam
1105 AZ
Netherlands

Website http://www.kit.nl/
ROR logo "ROR" https://ror.org/01z6bgg93

Funders

Funder type

Research organisation

Royal Tropical Institute (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/11/2008 06/01/2021 Yes No

Editorial Notes

06/01/2021: Publication reference and total final enrolment added.