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
Secondary identifying numbers	N/A

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

Email	t.bousema@ncmls.ru.nl

Study information

Study design	Randomised single blind drug study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
Scientific title	Monitoring of Anti-Malarial Drug resistance by real-time quantitative nucleic acid sequence-based amplification and the impact on TRANSmission of Plasmodium falciparum
Study acronym	AMD-TRANS
Study objectives	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(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) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sulphadoxine, pyrimethamine, artesunate, amodiaquine and artemether-lumefantrine.
Primary outcome measure	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 study start date	01/09/2004
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	10 Years
Sex	Not Specified
Target number of participants	500
Key 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)
Key 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
Date of first enrolment	01/09/2004
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

Kenya
Netherlands

Study participating centre

Radboud University Nijmegen Medical Centre

Nijmegen
6500HB
Netherlands

Sponsor information

The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (The Netherlands)
Research organisation

Laan van Nieuw Oost-Indie 300
P.O. Box 93138
Den Haag
2509 AC
Netherlands

Email	nwo@nwo.nl
Website	http://www.nwo.nl/nwohome.nsf/pages/NWOA_6UB9S8_Eng
"ROR"	https://ror.org/04jsz6e67

Funders

Funder type

Research organisation

The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (The Netherlands) (ref: 2003/00702)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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