Targeted Chemo-elimination (TCE) of Malaria

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall aim of this study is two fold:

1. to pilot targeted chemo-elimination of plasmodium falciparum malaria in known areas of artemisinin resistance in South East Asia.

2. to understand the micro-epidemiology of malaria in these areas; chiefly, the prevalence and importance to on-going transmission of sub-clinical p.f malaria infections.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oxford
• Collaborators: Family Health International, Cambodia; FHI 360; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit; Mahidol Oxford Tropical Medicine Research Unit; Mahidol Oxford Tropical Medicine Research Unit (MORU), Thailand; Myanmar Oxford Clinical Research Unit; Myanmar Oxford Clinical Research Unit (MOCRU), Myanmar; National Centre for Parasitology, Entomology and Malaria Control, Cambodia; National Malaria Control Program, Myanmar; National Malaria Control Program, Vietnam; Oxford University Clinical Research Unit (OUCRU), Vietnam; Oxford University Clinical Research Unit, Vietnam; Shoklo Malaria Research Unit; Shoklo Malaria Research Unit (SMRU), Thailand
• Treatments: Artemisinine; Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Primaquine

Criteria

OxTREC reference: 1017-13

Inclusion Criteria:

• Age ≥6 months, male or female,

• Written informed consent (by parent/guardian in case of children)

Exclusion Criteria:

• Pregnant women will not receive primaquine (urine pregnancy tests will be performed on women of appropriate age groups before drug administration at each TCE round)

• History of allergy or known contraindication to artemisinins, piperaquine or PQ

• Those who are, in the opinion of the study clinician, ill at the time of drug administration

OxTREC reference: 1015-13

Inclusion Criteria

• Age ≥6 months, male or female,

• Written informed consent (by legally acceptable representative in case of children)

• Healthy at the time of the survey or drug administration

• Not pregnant

Exclusion Criteria

• Significant non-compliance with study requirements

• Loss to follow up

• Suspected severe adverse events

• Severe illness

OxTREC reference: 23-15

Part 1. qPCR survey for identification of potential TMT villages;

Inclusion criteria:

• Males and females 18 and above

• Written informed consent

Exclusion criteria:

• Pregnant women in their first trimester

• Presence of any acute severe illness at the time of survey

Part 2. TMT villages will be given directly observed therapy (DOT) with DP for 3 days and PQ (0.25 mg/kg) will be given on day 1

Inclusion criteria for TMT

• Age ≥one year, male and female,

• Willing to provide consent for those 18 years and above. For children 10-18 years old, parents/guardians must provide consent, and the children must provide assent. For children below 10 years old, the parents/guardians must provide consent.

Exclusion criteria for TMT

• History of allergy or known contraindication to artemisinins, piperaquine or PQ.

• Refusal of treatment.

• Pregnant women in their 1st trimester.