Condition category
Infections and Infestations
Date applied
01/02/2007
Date assigned
01/02/2007
Last edited
01/02/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.kit.nl/

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

Results - basic reporting

Publication summary

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) 35–41
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15279949

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