Condition category
Infections and Infestations
Date applied
31/10/2006
Date assigned
27/03/2007
Last edited
27/03/2007
Prospective/Retrospective
Retrospectively 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 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

http://www.nwo.nl/nwohome.nsf/pages/NWOA_6UB9S8_Eng

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

Publication citations

Additional files

Editorial Notes