Trials / Withdrawn
WithdrawnNCT02461186
Arterolane-PQP Versus DHA-PQP in Uncomplicated Falciparum Malaria in Eastern Myanmar
An Open-label Randomized Trial to Assess the Therapeutic Efficacy of Arterolane-piperaquine Versus Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Eastern Myanmar, an Area of Emerging Artemisinin-resistant Falciparum Malaria
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Emerging resistance to artemisinins and their partner drugs severely threatens the treatment of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug policy, it is crucial to evaluate alternative antimalarial treatments. The investigators here propose a randomized clinical trial comparing parasite clearance parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria in Myanmar stratified for the presence of "K13" mutation in the infecting parasite strains.
Detailed description
Primary Objective: \- To assess the parasite clearance half-life of arterolane-piperaquine compared to DHA-piperaquine in patients with artemisinin resistant uncomplicated falciparum malaria, defined by presence of the "K13" mutations in the infecting parasite strain. Secondary Objectives : * To assess the therapeutic efficacy of arterolane-piperaquine and DHA-piperaquine for the treatment of uncomplicated falciparum malaria or mixed infection (P.falciparum (PF) + a non-falciparum species) at Day 42, stratified by presence of artemisinin resistance in the infecting parasite strain. * To assess the frequency of adverse events and serious adverse events of arterolane-piperaquine compared to DHA-piperaquine. * To assess other efficacy parameters related to parasite clearance and parasite cure rate as well as the gametocyte carriage. * To obtain pharmacokinetic (PK) and pharmacokinetic/pharmacodynamics (PK/PD) data on arterolane-piperaquine and DHA-piperaquine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Arterolane maleate-piperaquine phosphate (Synriam) | |
| DRUG | Dihydroartemisinin-piperaquine phosphate (Duocotexin) |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2015-06-03
- Last updated
- 2015-11-03
Source: ClinicalTrials.gov record NCT02461186. Inclusion in this directory is not an endorsement.