Clinical trial NCT02788864: Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Forest ranger
P.falciparum
P.vivax
Dihydroartemisinine-piperaquine (DP)
Primaquine
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: Binh Phuoc Malaria Control Centre
name: Bu Gia Map National Park, Binh Phuoc Province, Vietnam
First posted: 2016-06-02
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: at 2 weeks after coming back from the forest
Secondary outcomes:
measure: The proportion of different anopheles species amongst all captured mosquito anopheles
timeFrame: 1 month
measure: The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax)
timeFrame: 6 months
Other outcomes:
Locations:
city: Binh Phuoc
country: Vietnam
facility: Bu Gia Map Commune Health Station
Study officials:
affiliation: Oxford University Clinical Research Unit
name: Hung Son Do, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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