Alternative Study/Cohort Name(s)
Key Institution involved
Partner Institution(s) involved
Key Contact for the Study
Brief Study Explanation
Year(s) of Study
Time Frame of Study (months)
Number of Measurements and Time Between Measurements
Study Type (CSS, Cohort, etc)
Location of Study (Country)
Location of Study (Sites)
Size of Study Cohort/Sample set to be reqcruited
Actual size of Study Cohort/Sample set to be reqcruited
Age of Participants
Sample Collection Methods
Types of Sample
Current Sample Location(s)
Plasmodium Species Studied
Infection Status by LM
Infection Status by RDT
Infection Status by PCR
Infection Status by Serology
Blood Stage Data Availability
Species Specific Data
Gametocyte Data Availability
Denisty Data Availability
Drug Regimen (For treatment studies)
Availability of Data on Related Conditions
Availability of Demographic Data
Availability of Entomology Data and Data Type
Ethical Approval (and consent of participants)
Australian Ethics Number
Local Region Ethics Number
A stepped-wedge cluster randomised trial of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar
Burnet Institute, Victoria, Australia, and Yangon, Myanmar.
Department of Public Health, Myanmar Ministry of Health and Sports, Nay Pyi Taw, Myanmar
The aim of the trial was to assess the effectiveness of personal insect repellent distributed to villages through Village Health Volunteers (VHVs) in malaria control and elimination programs for artemisinin resistance containment in geographically isolated, high-risk populations in Myanmar. Furthermore, the trial aimed to understand the broader implications of personalised malaria control measures, specifically on the presence of molecular-detected P. falciparum and P. vivax parasites, parasite mutations that confer drug resistance and its impact on naturally-acquired immunity to malaria. Additionally, studies were conducted to integrate a more sensitive diagnostic molecular and serological measures into the VHV network that could improve surveillance of residual malaria transmission in hard-to-reach areas in the region.
2015 and 2016
April 2015 to June 2016
20 participants per village were samples monthly, in a total of 14 months
open stepped-wedge cluster-randomised controlled trial, randomised at the village level
Isolated villages (114) and hard-to-reach territories in the states of Kayin, Kayah, Bago East region
Available for majority of villages
For high risk populations (mobile and migrant people and residents who are also forest dwellers) over 6 months of age received the repellent.
Individuals of all ages and genders willing to undergo RDT for malaria from villages included in the 3MDG (Three Millennium Development Goal) malaria program, who had not previously received repellent.
20 participants/village, being all ages for RDT, and >6 months for repellent study.
32,194 RDTs/total observations and 14,128 dried blood spots from 10,857 individuals.
0.1 to 100 years old
Topical insect repellent (12% N,N-diethylbenzamide w/w cream)
prevalence of P. falciparum and P. vivax infection, levels and seroprevalence of IgG for both species, contemporaneous infection, infection at next presentation, cost-effectiveness of repellent, adherence to intervention (repellent)
dry blood spot (DBS)
dry blood spot (DBS), DNA
14,128 dried blood spots, Burnet Institute, contact Katherine O’Flaherty or Freya Fowkes
Plasmodium falciparum, Plasmodium vivax
qPCR – available
IgG analysis – available
Fever and RDT positive recorded
pregnancy, RDT result, uncomplicated/severe malaria, reported malaria symptoms
The trial was explained to the community, and community leaders and stakeholders gave community consent for the distribution of insect repellent, so the individuals were not required to sign a consent form in order to receive repellent. An informed consent form written in ethnic language was provided to men, women, and parents of children given a RDT for malaria. Informed consent was sought from individuals who provided to a finger prick sample of blood onto filter paper. Unrestricted informed consent will be requested for use of leftover filter paper samples in future studies. Any new tests not covered in the present protocol will not be carried out unless a separate approval is obtained from the relevant ethics committees in Myanmar and Melbourne
Alfred Hospital, Melbourne, Australia (95/15)
Ethics Review Committee on Medical Research involving Human Subjects, Department of Medical Research, Ministry of Health and Sports, Myanmar Government (#21/Ethics/2015; extended approval #Ethics/DMR/2016/020). The ethics review committee of the Department of Medical Research, Ministry of Health and Sports, requested that there be no commercial advantage for the product during the trial. Consequently, the repellent was provided in plain unbranded tubes, and the investigators registered the trial after completion of fieldwork (but prior to the commencement of data analysis) to minimise public disclosure.
Tracking resistance to artemisinins collaboration (TRAC)
Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research, University of Oxford, Oxford OX3 7FZ, United Kingdom
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC 3010, Australia;
Worldwide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford OX3 7FZ, United Kingdom
Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852
National Center for Parasitology, Entomology and Malaria Control, Phnom Penh 12101, Cambodia
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand
Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Quan 5, Ho Chi Minh City, Vietnam
Department of Medical Research, Lower Myanmar, Yangon 11191, Myanmar
Lao-Oxford-Mahosot Hospital-Wellcome Trust-Research Unit, Mahosot Hospital, Vientiane, Lao PDR
Malaria Research Group & Dev Care Foundation, Chittagong, Bangladesh
Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Tak 63110, Thailand
Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of Congo
Department of Paediatrics and Child Health, University of Ilorin, Ilorin, Nigeria
This is a multi-centre study with the primary objective of comparing the P. falciparum parasite clearance compared to a reference parasite clearance rate obtained from historical data in artemisinin sensitive falciparum malaria. The aim of this large scale study is to determine if artemisinin resistance has spread and if so, how far it has spread. Additionally immunological investigation was pursued to determine the role of acquired antimalarial immunity on the phenotype of artemisinin resistance.
2011 to 2013
May 2011 to April 2013
Blood smears taken for malaria parasite counts at 0, 4, 6, 8, 12 hours and then every 6 hours until two consecutive counts were negative, days 7, 14, 28 and 42.
RCT (therapeutic efficacy trial)
Cambodia, Thailand, Laos, Vietnam, Myanmar, Bangladesh, Democratic Republic of Congo and Nigeria (original TES also recruited in India and Kenya but data/samples not available to ACREME investigators)
Ramu (Bangladesh); Pailin, Preah Vihear, Pursat, Ratanakiri (Cambodia); Attapeu (Laos); Shwe Kyin (Myanmar); Mae Sot, Ranong, Srisaket (Thailand); Binh Phuoc (Vietnam), Kinshasa (DRC); Ilorin (Nigeria)
Patients aged 6 months to 65 years with acute uncomplicated falciparum malaria (or mixed with non-falciparum species), parasite density between 10,000 and 200,000/μl, and fever
120 patients/study site
1,114 samples (Ramu n = 49; Pailin n = 99, Preah Vihear n = 120, Pursat n = 120, Ratanakiri n = 120; Attapeu n = 93; Shwe Kyin n = 79; Mae Sot n = 120, Ranong n = 23, Srisaket n = 41; Binh Phuoc n = 120, Kinshasa n = 119; Ilorin n = 11)
Dose (artesunate monotherapy), Artemisinin-Combination Therapy, kelch13 Allele, IgG level, IgG seroprevalence
parasite clearance half-life (hours), parasite clearance half-life of more than 5 hours, parasitemia detected on day 3, gametocytemia after treatment, the incidence of anaemia, efficacy of the 6-day artesunate regimen plus artemisinin-based combination therapy, corrected by means of PCR genotyping, treatment, duration of treatment, duration of follow-up, total number of patients, number of patients with recurrence of infection, efficacy (with and without PCR correction), adverse events, parasitemia (blood and sexual stage) by LM at follow-up timepoints.
KH***-***; NG***-***, TH***-***, MM***-***, BD***-***, VN***-***, LA***-***, NG***-***, CD***-***
Burnet Institute, MORU/WWARN
Aliquots for all participant samples (n = 1,114) located at Burnet Institute but sample volume is extremely limited, contact Freya Fowkes or Katherine O’Flaherty
PCR genotyping of LM positives
LM (PCR genotyping), serology.
yes, LM only
yes, blood and sexual stage, LM only
Uncomplicated Pf malaria (fever and LM) inclusion criteria
Participants were randomised to receive either 2 or 4 mg/kg artesunate for 3 days followed by a full course of an ACT at most sites. In Western Cambodia and Srisaket, Thailand, where higher grade artemisinin resistance was already reported, only the 4 mg/kg dose was evaluated.
weight, PCt1/2, kelch13 mutant, mixed infecton, hematocrit
Written informed consent (unspecified) to participate in this study was provided by all participants/participants legal guardian/next of kin.
Alfred Hospital Committee for Ethics (485/12)
Oxford Tropical Research Ethics Committee – OxTREC 06 11 and relevant national ethics committees (Thailand: Ethics Committee of the Faculty of Tropical Medicine, Mahidol University and Tak Province Community Ethics Advisory Board (T-CAB), Cambodia: National Ethics Committee for Health Research, Ministry of Health, Kingdom of Cambodia Institutional Review Board and National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA, Myanmar: The Government of the Republic of the Union of Myanmar, Ministry of Health, Department of Medical Research (Lower Myanmar), Laos: Ministry of Health. National Ethics Committee for Health Research, Lao Peoples’ Democratic Republic, Nigeria: Ethical Review Committee, University of Ilorin Teaching Hospital, Ilorin, Nigeria, Bangladesh: National Research Ethics Committee, Bangladesh Medical Research Council, Democratic Republic of the Congo: Republique Democratique du Congo, Ministere de l’Enseignement Superieur, Universitaire et Recherche Scientifique, Universite de Kinshasa, Ecole de Sante Publique Comite d’Ethique and Viet Nam: Ethics Committee for biomedical research of the Ministry of Health, Institute of Malariology-Parasitology-Entomology, Ho Chi Minh City).