Contact information
Type
Scientific
Primary contact
Dr Teun Bousema
ORCID ID
Contact details
Radboud University Nijmegen Medical Centre
Department of Medical Microbiology 268
P.O. Box 9101
Nijmegen
6500HB
Netherlands
t.bousema@ncmls.ru.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
AMD-TRANS
Study hypothesis
Firstline anti-malarial drugs can have a different impact on transmission of Plasmodium falciparum. Few studies have directly addressed this issue and frequently used microscopical detection of gametocytes as an endpoint. In the current proposal we use a molecular gametocyte detection technique to detect gametocytes and study post-treatment infectiousness to mosquitoes in an experiment set-up.
Hypothesis: submicroscopic gametocytaemia is common before and after treatment and the use of artesunate will reduce post-treatment malaria transmission.
Ethics approval
Approval received from the Kenya Medical Research Institute on the 15th July 2004 (ref: SSC no. 791, KEMRI/RES/7/3/1).
Study design
Randomised single blind drug study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
Uncomplicated febrile malaria
Intervention
Participants will be randomised to treatment with:
1. Sulphadoxine (25 mg/kg) and pyrimethamine (1.25 mg/kg) as a single dose plus placebo once daily for three days
2. SP plus Artesunate (AS), 4 mg/kg once daily for three days
3. SP plus Amodiaquine (AQ), 10 mg/kg once daily for three days
4. Artemether-Lumefantrine, administered as oral tablet (20 mg artemether, 120 mg lumefantrine) per 5 kg body weight in the six-dose regimen: at enrolment and eight, 20, 32, 44, 56 hours (90 min) after the initiation of treatment
Intervention type
Drug
Phase
Not Specified
Drug names
Sulphadoxine, pyrimethamine, artesunate, amodiaquine and artemether-lumefantrine.
Primary outcome measures
The following are assessed on days one, two, three, seven, 14 and 28 after initiation of treatment:
1. Resolution of clinical symptoms
2. Presence of malaria parasites by microscopy and molecular techniques
3. Presence of sexual stage malaria parasites by microscopy and molecular techniques
4. Haematological recovery
On day 14 the infectiousness to mosquitoes will be assessed by taking a small venous blood sample (2 mL) from children aged less than two years for membrane feeding assays. The blood sample will be offered to locally reared mosquitoes through a membrane. The number of infected mosquitoes and the number of oocysts in infected mosquitoes are primary outcomes for this part of the study.
Secondary outcome measures
1. Selection of drug-resistant parasite strains after treatment
2. Transmission of drug-resistant parasite strains after treatment
Overall trial start date
01/09/2004
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age six months to ten years
2. Residents of research area, able to come for complete schedule of follow-up
3. Diagnosed with uncomplicated malaria, Plasmodium falciparum or P. falciparum and P. malariae double infection
4. Parasitaemia 1000 to 100,000 P. falciparum P/ul (Giemsa-stained blood smears counted against 200 White Blood Cells (WBC), negative result if 100 parasite negative microscopic fields)
5. Temperature more than 37.5°C and less than 39.5°C, or a history of fever in the previous 24 hours
6. No history of adverse reactions to Sulphadoxine-Pyrimethamine (SP) treatment
7. Understanding of the procedures of the study by parent or guardian and willing to participate (informed consent signed)
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
500
Participant exclusion criteria
1. General danger signs of severe malaria or Haemoglobin (Hb) count more than 5 gm/dl
2. Severe malnutrition
3. Presence of diseases other than malaria causing febrile conditions
4. Unwilling to participate and sign informed consent forms
Recruitment start date
01/09/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Kenya
Trial participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500HB
Netherlands
Sponsor information
Organisation
The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (The Netherlands)
Sponsor details
Laan van Nieuw Oost-Indie 300
P.O. Box 93138
Den Haag
2509 AC
Netherlands
nwo@nwo.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (The Netherlands) (ref: 2003/00702)
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