Status:
COMPLETED
Targeted Chemo-elimination (TCE) of Malaria
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Mahidol Oxford Tropical Medicine Research Unit
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
6+ years
Phase:
NA
Brief 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 mi...
Detailed Description
The spread of artemisinin resistance in Plasmodium falciparum, which compromises the therapeutic efficacy of artemisinin combination treatments (ACTs), is the greatest threat to current global initiat...
Eligibility Criteria
Inclusion
- OxTREC reference: 1017-13
- Age ≥6 months, male or female,
- Written informed consent (by parent/guardian in case of children)
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT01872702
Start Date
April 1 2013
End Date
July 1 2017
Last Update
August 28 2020
Active Locations (5)
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1
Mahidol Oxford Clincal Research Unit, Myanmar
Rangoon, Burma
2
Pailin
Pailin, Cambodia, 372
3
Savannakhet
Savannakhet, Laos
4
Shoklo Malaria Research Unit
Mae Sot, Changwat Tak, Thailand