Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers

NCT02788864 | Completed Phase 4 DMC

• 1 other identifier: 17MA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria

Keywords

Forest ranger; P.falciparum; P.vivax; Dihydroartemisinine-piperaquine (DP); Primaquine

Outcome Measures

Primary Outcomes (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

  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.

  at 2 weeks after coming back from the forest

Secondary Outcomes (2)

• The proportion of different anopheles species amongst all captured mosquito anopheles

  1 month

• The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax)

  6 months

Study Arms (2)

Arterakine

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

Placebo (visually matched to Arterakine for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

Drug: Placebo

Interventions

Arterakine (DHA/piperaquine) DRUG

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)

Arterakine

Placebo DRUG

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)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to tolerate oral treatment
• Previous episode of haemolysis or severe haemoglobinuria following primaquine
• Glucose-6-phosphate dehydrogenase (G6PD) deficient with Hb \< 9 g/dL \*
• 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.

Sponsors & Collaborators

• Bu Gia Map National Park, Binh Phuoc Province, Vietnam: collaborator
• Oxford University Clinical Research Unit, Vietnam: lead
• Binh Phuoc Malaria Control Centre: collaborator

Study Sites (1)

Bu Gia Map Commune Health Station

Bình Phước, Binh Phuoc, 830000, Vietnam

Location

Related Publications (9)

• Thanh PV, Van Hong N, Van Van N, Van Malderen C, Obsomer V, Rosanas-Urgell A, Grietens KP, Xa NX, Bancone G, Chowwiwat N, Duong TT, D'Alessandro U, Speybroeck N, Erhart A. Epidemiology of forest malaria in Central Vietnam: the hidden parasite reservoir. Malar J. 2015 Feb 19;14:86. doi: 10.1186/s12936-015-0601-y.

  PMID: 25880664 BACKGROUND

• Parker DM, Carrara VI, Pukrittayakamee S, McGready R, Nosten FH. Malaria ecology along the Thailand-Myanmar border. Malar J. 2015 Oct 5;14:388. doi: 10.1186/s12936-015-0921-y.

  PMID: 26437860 BACKGROUND

• Abe T, Honda S, Nakazawa S, Tuong TD, Thieu NQ, Hung le X, Thuan le K, Moji K, Takagi M, Yamamoto T. Risk factors for malaria infection among ethnic minorities in Binh Phuoc, Vietnam. Southeast Asian J Trop Med Public Health. 2009 Jan;40(1):18-29.

  PMID: 19323029 BACKGROUND

• Sanh NH, Van Dung N, Thanh NX, Trung TN, Van Co T, Cooper RD. Forest malaria in central Vietnam. Am J Trop Med Hyg. 2008 Nov;79(5):652-4.

  PMID: 18981498 BACKGROUND

• Erhart A, Ngo DT, Phan VK, Ta TT, Van Overmeir C, Speybroeck N, Obsomer V, Le XH, Le KT, Coosemans M, D'alessandro U. Epidemiology of forest malaria in central Vietnam: a large scale cross-sectional survey. Malar J. 2005 Dec 8;4:58. doi: 10.1186/1475-2875-4-58.

  PMID: 16336671 BACKGROUND

• Erhart A, Thang ND, Hung NQ, Toi le V, Hung le X, Tuy TQ, Cong le D, Speybroeck N, Coosemans M, D'Alessandro U. Forest malaria in Vietnam: a challenge for control. Am J Trop Med Hyg. 2004 Feb;70(2):110-8.

  PMID: 14993619 BACKGROUND

• Imwong M, Nguyen TN, Tripura R, Peto TJ, Lee SJ, Lwin KM, Suangkanarat P, Jeeyapant A, Vihokhern B, Wongsaen K, Van Hue D, Dong le T, Nguyen TU, Lubell Y, von Seidlein L, Dhorda M, Promnarate C, Snounou G, Malleret B, Renia L, Keereecharoen L, Singhasivanon P, Sirithiranont P, Chalk J, Nguon C, Hien TT, Day N, White NJ, Dondorp A, Nosten F. The epidemiology of subclinical malaria infections in South-East Asia: findings from cross-sectional surveys in Thailand-Myanmar border areas, Cambodia, and Vietnam. Malar J. 2015 Sep 30;14:381. doi: 10.1186/s12936-015-0906-x.

  PMID: 26424000 BACKGROUND

• Imwong M, Hanchana S, Malleret B, Renia L, Day NP, Dondorp A, Nosten F, Snounou G, White NJ. High-throughput ultrasensitive molecular techniques for quantifying low-density malaria parasitemias. J Clin Microbiol. 2014 Sep;52(9):3303-9. doi: 10.1128/JCM.01057-14. Epub 2014 Jul 2.

  PMID: 24989601 BACKGROUND

• Son DH, Thuy-Nhien N, von Seidlein L, Le Phuc-Nhi T, Phu NT, Tuyen NTK, Tran NH, Van Dung N, Van Quan B, Day NPJ, Dondorp AM, White NJ, Thwaites GE, Hien TT. The prevalence, incidence and prevention of Plasmodium falciparum infections in forest rangers in Bu Gia Map National Park, Binh Phuoc province, Vietnam: a pilot study. Malar J. 2017 Nov 6;16(1):444. doi: 10.1186/s12936-017-2091-6.

  PMID: 29110709 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Hung Son Do, Dr

  Oxford University Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: May 20, 2016
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)