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CompletedNCT01743820Updated Jan 19, 2015

Phase2a Primaquine Dose Escalation Study

A Phase 2 interventional study of dihydroartemisinin-piperaquine and 0.125 mg/kg Primaquine in Malaria, sponsored by University of California, San Francisco. Completed at 1 site in Mali. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Malaria

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03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 81 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • Active comparator
    dihydroartemisinin-piperaquine only

    dihydroartemisinin -piperaquine (DP) only

    Drug: dihydroartemisinin-piperaquine

  • Experimental
    DP and 0.125 mg/kg primaquine

    DP and single dose oral 0.125 mg/kg primaquine

    Drug: dihydroartemisinin-piperaquine · Drug: 0.125 mg/kg Primaquine

  • Experimental
    DP and 0.5 mg/kg primaquine

    DP and single dose oral 0.5 mg/kg primaquine

    Drug: dihydroartemisinin-piperaquine · Drug: 0.5 mg/kg Primaquine

  • Experimental
    DP and 0.25 mg/kg primaquine

    DP and a single dose oral 0.25 mg/kg primaquine

    Drug: dihydroartemisinin-piperaquine · Drug: 0.25 mg/kg Primaquine

  • Experimental
    DP and 0.0625 mg/kg primaquine

    DP and a single dose oral 0.0625 mg/kg primaquine

    Drug: dihydroartemisinin-piperaquine · Drug: 0.0625 mg/kg Primaquine

Interventions

  • Drugdihydroartemisinin-piperaquine
  • Drug0.125 mg/kg Primaquine
  • Drug0.5 mg/kg Primaquine
  • Drug0.25 mg/kg Primaquine
  • Drug0.0625 mg/kg Primaquine
06

What researchers measure

Primary outcomes

  1. mosquito infectivity assessed through membrane feeding

    Baseline, Days 1, 2, 7

    Time frame: 7 days

Secondary outcomes

  1. gametocyte prevalence and density

    Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

    Time frame: 28 days

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

    Hours 1, 2, 3, 4, 6, 8, 12, 24

    Time frame: 24 hours

  3. asexual parasite prevalence and density

    Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

    Time frame: 28 days

  4. safety measurements including hemoglobin and signs of hemolysis

    Baseline, Days 1, 2, 3, 7, 14, 28

    Time frame: 28 days

07

Study locations

1 site
  • Malaria Research and Training Centre
    Bamako, Mali
08

References and documents

Publications

  • 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. PubMed 21951597 ↗
  • 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. PubMed 17254503 ↗
  • WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.
  • WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization
  • 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. PubMed 18074034 ↗
  • 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. PubMed 20194698 ↗
  • 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. Erratum In: Lancet Infect Dis. 2017 Jan;17(1):17. doi: 10.1016/S1473-3099(16)30511-4. PubMed 26906747 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01743820
Lead sponsor
University of California, San Francisco
Collaborators
Malaria Research and Training Center, Bamako, Mali, Shoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Bill and Melinda Gates Foundation, Wellcome Trust
Responsible party
Sponsor
First posted
Dec 6, 2012
Start date
Sep 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 19, 2015

Study contacts

Roland Gosling, MD, PhD
principal investigator · University of California, San Francisco
Alassane Dicko, MD
principal investigator · Malaria Research and Training Centre
François Nosten, MD
principal investigator · Shoklo Malaria Research Unit

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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