Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: Arterakine (DHA/piperaquine); Drug: Placebo

• Registration Number: NCT02788864
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2016-05-20
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-06-02
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arterakine	Arterakine (DHA/piperaquine)	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)
Placebo	Placebo	Placebo (visually matched to Arterakine for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
The proportion of different anopheles species amongst all captured mosquito anopheles	1 month	The proportion of different anopheles species amongst all captured mosquito anopheles as identified by morphology
The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax)	6 months	The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax) as assessed by PCR.

Trial Locations

Locations (1)

Bu Gia Map Commune Health Station; 🇻🇳 Binh Phuoc, Vietnam