NCT01743820

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

November 26, 2012

Last Update Submit

January 16, 2015

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • mosquito infectivity assessed through membrane feeding

    Baseline, Days 1, 2, 7

    7 days

Secondary Outcomes (4)

  • gametocyte prevalence and density

    28 days

  • primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite

    24 hours

  • asexual parasite prevalence and density

    28 days

  • safety measurements including hemoglobin and signs of hemolysis

    28 days

Study Arms (5)

dihydroartemisinin-piperaquine only

ACTIVE COMPARATOR

dihydroartemisinin -piperaquine (DP) only

Drug: dihydroartemisinin-piperaquine

DP and 0.125 mg/kg primaquine

EXPERIMENTAL

DP and single dose oral 0.125 mg/kg primaquine

Drug: dihydroartemisinin-piperaquineDrug: 0.125 mg/kg Primaquine

DP and 0.5 mg/kg primaquine

EXPERIMENTAL

DP and single dose oral 0.5 mg/kg primaquine

Drug: dihydroartemisinin-piperaquineDrug: 0.5 mg/kg Primaquine

DP and 0.25 mg/kg primaquine

EXPERIMENTAL

DP and a single dose oral 0.25 mg/kg primaquine

Drug: dihydroartemisinin-piperaquineDrug: 0.25 mg/kg Primaquine

DP and 0.0625 mg/kg primaquine

EXPERIMENTAL

DP and a single dose oral 0.0625 mg/kg primaquine

Drug: dihydroartemisinin-piperaquineDrug: 0.0625 mg/kg Primaquine

Interventions

dihydroartemisinin-piperaquineDRUG
DP and 0.0625 mg/kg primaquineDP and 0.125 mg/kg primaquineDP and 0.25 mg/kg primaquineDP and 0.5 mg/kg primaquinedihydroartemisinin-piperaquine only
0.125 mg/kg PrimaquineDRUG
DP and 0.125 mg/kg primaquine
0.5 mg/kg PrimaquineDRUG
DP and 0.5 mg/kg primaquine
0.25 mg/kg PrimaquineDRUG
DP and 0.25 mg/kg primaquine
0.0625 mg/kg PrimaquineDRUG
DP and 0.0625 mg/kg primaquine

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age \>= 18 years and \< 50 years
  • Malaria blood thick film positive
  • Presence of gametocytes on thick blood film
  • Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
  • No allergies to study drugs
  • Hemoglobin \>= 8 g/dl
  • No evidence of severe or chronic disease
  • Written, informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research and Training Centre

Bamako, Mali

Location

Related Publications (7)

  • Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26.

    PMID: 21951597BACKGROUND

  • Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4.

    PMID: 17254503BACKGROUND

  • WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.

    BACKGROUND

  • WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization

    BACKGROUND

  • El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.

    PMID: 18074034BACKGROUND

  • Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1.

    PMID: 20194698BACKGROUND

  • Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20.

    PMID: 26906747DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Roland Gosling, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Alassane Dicko, MD

    Malaria Research and Training Centre

    PRINCIPAL INVESTIGATOR

  • François Nosten, MD

    Shoklo Malaria Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 6, 2012

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

MA(1)