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To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

NCT02497612 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2022-03-24

Study results available
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Summary

Primary Objective:

To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.

Secondary Objectives:

* To evaluate the efficacy of OZ439/FQ:

* To determine the incidence of recrudescence and re-infection.
* To determine the time to relief of fever and parasite clearance.
* To evaluate the safety and tolerability of OZ439/FQ in adults and children.
* To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood.
* To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.

Conditions

  • Plasmodium Falciparum Infection

Interventions

DRUG

Ferroquine SSR97193

Pharmaceutical form:Capsules Route of administration: oral

DRUG

Artefenomel

Pharmaceutical form:Granules for suspension Route of administration: oral

OTHER

Placebo

Capsules. Placebo capsules were used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No participant received placebo only.

Sponsors & Collaborators

  • Medicines for Malaria Venture

    collaborator OTHER

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-25
Primary Completion
2019-09-23
Completion
2019-09-23

Countries

  • Benin
  • Burkina Faso
  • Gabon
  • Kenya
  • Mozambique
  • Uganda
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497612 on ClinicalTrials.gov