Targeted Chemo-elimination (TCE) of Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01872702
• Date of registration: 04/06/2013
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: Targeted Chemo-elimination (TCE) of Malaria TME
• Scientific title: Targeted Chemo-elimination (TCE) to Eradicate Malaria in Areas of Suspected or Proven Artemisinin Resistance in Southeast Asia and South Asia
• Date of first enrolment: April 2013
• Target sample size: 8000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01872702
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Cambodia, Lao People's Democratic Republic, Myanmar, Thailand, Vietnam

Contacts

• Name: Nicholas J White, PhD
• Affiliation: University of Oxford

Key inclusion & exclusion 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.



Age minimum: 6 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Plasmodium Falciparum Malaria

Intervention(s)

Drug: malaria elimination using DP and low-dose primaquine

Primary Outcome(s)

prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of targeted malaria elimination (1015-13) [Time Frame: 12 months]

prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 4 months after the first administration of target malaria-elimination (23-15) [Time Frame: 4 months]

prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of treatment with dihydroartemisinin-piperaquine and primaquine. (1017-13 and 23-15) [Time Frame: 12 months]

Secondary Outcome(s)

Safety and acceptability of targeted malaria elimination (1017-13 and 1015-13) [Time Frame: 12 months]

Secondary ID(s)

BAKMAL1305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Centre for Parasitology, Entomology and Malaria Control, Cambodia

Oxford University Clinical Research Unit, Vietnam

Mahidol Oxford Tropical Medicine Research Unit

Shoklo Malaria Research Unit

Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

National Malaria Control Program, Myanmar

National Malaria Control Program, Vietnam

FHI 360

Myanmar Oxford Clinical Research Unit