Trials / Completed
CompletedNCT04049916
Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission
The Efficacy and Safety of Pyronaridine-artesunate Combined With Low Dose Primaquine for Preventing Transmission of P. Falciparum Gametocytes in Sub-Saharan Africa
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- London School of Hygiene and Tropical Medicine · Academic / Other
- Sex
- All
- Age
- 5 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2 and 7 days after treatment, the duration of infectivity in the artemisinin combination therapy (ACT) only arms, and the production and detectability of histidine rich protein II.
Detailed description
Protocol will be shared on request
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyronaridine Tetraphosphate/Artesunate | Adults: Tablets containing 180 mg pyronaridine-tetraphosphate/60mg artesunate (Pyramax, Shin Poong Pharmaceutical Co.), administered according to weight. Children: Granules containing 60 mg pyronaridine-tetraphosphate/20mg artesunate, administered according to weight. |
| DRUG | Dihydroartemisinin/Piperaquine | Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau), administered according to weight. |
| DRUG | Primaquine Diphosphate | Extemporaneous preparation of 1mg/mL primaquine phosphate solution, from tablets containing 30mg primaquine (A-PQ 30®, ACE pharmaceuticals, NL) dissolved in 30mL water with a non-interacting fruit-flavoured syrup. Solution will be given at 0.25mg/kg. |
Timeline
- Start date
- 2019-09-12
- Primary completion
- 2020-01-07
- Completion
- 2020-01-07
- First posted
- 2019-08-08
- Last updated
- 2020-01-30
Locations
2 sites across 2 countries: Mali, Netherlands
Source: ClinicalTrials.gov record NCT04049916. Inclusion in this directory is not an endorsement.