Monitoring of Anti-Malarial Drug resistance by real-time quantitative nucleic acid sequence-based amplification and the impact on TRANSmission of Plasmodium falciparum

ISRCTN ISRCTN31291803
DOI https://doi.org/10.1186/ISRCTN31291803
Protocol serial number N/A
Sponsor The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (The Netherlands)
Funder The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (The Netherlands) (ref: 2003/00702)
Submission date
31/10/2006
Registration date
27/03/2007
Last edited
26/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Teun Bousema
Scientific

Radboud University Nijmegen Medical Centre
Department of Medical Microbiology 268
P.O. Box 9101
Nijmegen
6500HB
Netherlands

t.bousema@ncmls.ru.nl

Study information

Primary study designInterventional
Study designRandomised single blind drug study
Secondary study designRandomised controlled trial
Scientific titleMonitoring of Anti-Malarial Drug resistance by real-time quantitative nucleic acid sequence-based amplification and the impact on TRANSmission of Plasmodium falciparum
Study acronymAMD-TRANS
Study objectivesFirstline 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(s)Approval received from the Kenya Medical Research Institute on the 15th July 2004 (ref: SSC no. 791, KEMRI/RES/7/3/1).
Health condition(s) or problem(s) studiedUncomplicated febrile malaria
InterventionParticipants 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 typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sulphadoxine, pyrimethamine, artesunate, amodiaquine and artemether-lumefantrine.
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

1. Selection of drug-resistant parasite strains after treatment
2. Transmission of drug-resistant parasite strains after treatment

Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit10 Years
SexNot Specified
Target sample size at registration500
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/09/2004
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Kenya
  • Netherlands

Study participating centre

Radboud University Nijmegen Medical Centre
Nijmegen
6500HB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

26/08/2021: Proactive update review. No publications found. Search options exhausted.

BMC - Part of Springer Nature Springer Nature