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Trial record 1 of 1 for:    NCT02788864
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Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers (PREMAL)

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ClinicalTrials.gov Identifier: NCT02788864
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : March 7, 2017
Sponsor:
Collaborators:
Binh Phuoc Malaria Control Centre
Bu Gia Map National Park, Binh Phuoc Province, Vietnam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

Brief 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

Condition or disease Intervention/treatment Phase
Malaria Drug: Arterakine (DHA/piperaquine) Drug: Placebo Phase 4

Detailed Description:

To assess the protective effect of 3-day DP regimen for forest rangers working for long-term in forest where malaria transmission is intense, all eligible forest rangers will be treated with a full course of DP + primaquine to eradicate all parasites which may survive in their blood while staying in non- malaria transmission areas.

Just before returning back to the forest participants will be randomized to receive either Arterakine (dihydroartemisinine (DHA)/piperaquine) (intervention arm) or placebo (control arm). Participants will be assessed for parasitemia before and after the forest trip with high volume, ultrasensitive, PCR (HVUqPCR). The minimum time span between two forest trips should be 20 days so participants could complete the 14 day primaquine course and the Arterakine (dihydroartemisinine (DHA)/piperaquine).

There is no limit in the duration between trips. Participants are tested for P.falciparum, P.vivax infection before they return to the forest.

Each participant will be visited 2 weeks or later after returning home from the forest and examined. The rationale for the added two weeks is to detect blood stages of infections, which may have been inoculated towards the end of the forest visit.

If found to be sick, the patient will be treated according to government treatment guidelines. A 4ml venous blood sample will be obtained for Hb and HVUSqPCR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-controlled, Double-blind Trial Using Dihydroartemisinine+Piperaquine (DP) to Protect Forest Workers From Malaria in Bu Gia Map National Park
Actual Study Start Date : May 20, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Arterakine
Active drug: Arterakine (DHA/piperaquine) one tablet contains 40 mg of dihydroartemisinin and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinin; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)
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)


Placebo Comparator: Placebo
Placebo (visually matched to Arterakine 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)





Primary Outcome Measures :
  1. the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) and the incidence rate of symptomatic malaria [ Time Frame: at 2 weeks after coming back from the forest ]
    The primary endpoints are the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) at 2 weeks after coming back from the forest assessed by high volume, ultrasensitive PCR (HVUSqPCR) and the incidence rate of symptomatic malaria (P.falciparum, mixed P.falciparum + P.vivax) during the two week follow-up period as assessed by the study doctor.


Secondary Outcome Measures :
  1. The proportion of different anopheles species amongst all captured mosquito anopheles [ Time Frame: 1 month ]
    The proportion of different anopheles species amongst all captured mosquito anopheles as identified by morphology

  2. The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax) [ Time Frame: 6 months ]
    The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax) as assessed by PCR.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Informed consent
  2. Male, over or equal to18 years of age
  3. Able and willing to comply with the study requirements and follow-up

Exclusion Criteria:

  1. Inability to tolerate oral treatment
  2. Previous episode of haemolysis or severe haemoglobinuria following primaquine
  3. Glucose-6-phosphate dehydrogenase (G6PD) deficient with Hb < 9 g/dL *
  4. Known hypersensitivity or allergy to any study drugs * If the participant with G6PD deficient gets malaria, primaquine would be used as recommended by World Health Organization (WHO) (once a week for 8 weeks) in combination with 3 days of chloroquine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788864


Locations
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Vietnam
Bu Gia Map Commune Health Station
Binh Phuoc, Vietnam, 830000
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Binh Phuoc Malaria Control Centre
Bu Gia Map National Park, Binh Phuoc Province, Vietnam
Investigators
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Principal Investigator: Hung Son Do, Dr Oxford University Clinical Research Unit
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT02788864    
Other Study ID Numbers: 17MA
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant data will be made available to researcher and public as a supporting material via open access journal and/or upon request by qualified research groups.
Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Forest ranger
P.falciparum
P.vivax
Dihydroartemisinine-piperaquine (DP)
Primaquine
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents