NCT02461186

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

May 26, 2015

Last Update Submit

November 2, 2015

Conditions

Uncomplicated Falciparum MalariaArtemisinin-resistant

Keywords

Arterolane-piperaquineDehydroartemisinin-piperaquinetherapeutic efficacyUncomplicated falciparum malariaArtemisinin-resistant

Outcome Measures

Primary Outcomes (1)

  • Peripheral blood parasite half-life

    Peripheral blood parasite half-life of the linear portion of the natural logarithm parasite clearance curve in patients with parasitaemia at inclusion \>10,000 parasites/µL

    2 years

Secondary Outcomes (1)

  • 42 day PCR corrected adequate clinical and parasitological response (ACPR)

    42 days

Study Arms (2)

Arterolane maleate-piperaquine phosphate (Synriam)

EXPERIMENTAL
Drug: Arterolane maleate-piperaquine phosphate (Synriam)

Dihydroartemisinin-piperaquine phosphate (Duocotexin)

EXPERIMENTAL
Drug: Dihydroartemisinin-piperaquine phosphate (Duocotexin)

Interventions

Arterolane maleate-piperaquine phosphate (Synriam)DRUG
Arterolane maleate-piperaquine phosphate (Synriam)
Dihydroartemisinin-piperaquine phosphate (Duocotexin)DRUG
Dihydroartemisinin-piperaquine phosphate (Duocotexin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged ≥ 18 year old
  • Symptomatic malaria infection, i.e. history of fever or presence of fever \>37.5°c (tympanic) within the last 24 hours.
  • Microscopic confirmation of asexual stages of P.falciparum (may be mixed with non-falciparum species) with a parasitaemia \>10,000 parasites/µL
  • Able to take oral medication
  • Willingness and ability of patients to comply with the study protocol for the duration of the study
  • Written informed consent given to participate in the trial

You may not qualify if:

  • Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age 18 to 45 year old)
  • P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000/µL).
  • Signs or symptoms indicative of severe malaria:
  • Impaired consciousness
  • Severe anaemia (Hct\<15%)
  • Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venipuncture sites
  • Respiratory distress
  • Severe jaundice
  • Have taken a full course DHA-piperaquine, artemether-lumefantrin or other antimalarial treatment in the previous 42 days
  • Known hypersensitivity to artemisinins or to piperaquine - defined as history of erythroderma/other severe cutaneous reaction or angioedema
  • History of splenectomy
  • History of taking medicinal products that are known to prolong the QTc interval, including:
  • Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
  • Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
  • Certain antimicrobial agents, including agents of the following classes:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Arjen M Dondorp, MD

    Mahidol Oxfrod Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 3, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 3, 2015

Record last verified: 2015-11