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Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers

NCT02788864 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-03-07

No results posted yet for this study

Summary

The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine + Piperaquine (DP) are effective in preventing malaria infection for forest ranger

Conditions

Interventions

DRUG

Arterakine (DHA/piperaquine)

Stage 1: Parasite Clearance * Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days * Primaquine (One tablet contains 13.2mg primaquine disphosphate/7.5mg base. Weight based regimen: 0.25mg base/kg) for 14 days Stage 2: Forest trip • Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

DRUG

Placebo

Stage 1: Parasite Clearance * Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days * Primaquine (One tablet contains 13.2mg primaquine disphosphate/7.5mg base. Weight based regimen: 0.25mg base/kg) for 14 days Stage 2: Forest trip • Placebo (visually matched to Arterakine (DHA/piperaquine) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

Sponsors & Collaborators

  • Binh Phuoc Malaria Control Centre

    collaborator UNKNOWN

  • Bu Gia Map National Park, Binh Phuoc Province, Vietnam

    collaborator UNKNOWN

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Hung Son Do, Dr · Oxford University Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-20
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788864 on ClinicalTrials.gov