Trial intelligence / Profile preview

FARM: Ferroquine + Artesunate in Uncomplicated Malaria

NCT00988507Phase 2

Key facts

Status
Terminated
Start
Oct 2009
Primary completion
Nov 2010
Countries
6
Sponsor
Sanofi
Modality
DNA Intercalators/Alkylators
Conditions
Plasmodium falciparum malaria
01

Overview

Phase 2, randomised, double-blind trial of ferroquine in Plasmodium falciparum malaria (4 arms), sponsored by Sanofi. Primary endpoint: Recrudescent infections at D28 at 28 days. Started Oct 2009; status: terminated.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • Ferroquine high dose + artesunate

    Ferroquine 6 mg/kg + artesunate 4 mg/kg for 3 days

  • Ferroquine medium dose + artesunate

    Ferroquine 4 mg/kg + artesunate 4 mg/kg for 3 days

  • Ferroquine low dose + artesunate

    Ferroquine 2 mg/kg + artesunate 4 mg/kg for 3 days

  • Ferroquine alone medium dose

    Ferroquine 4 mg/kg alone for 3 days

03

Who it enrols

Adults and children with uncomplicated Plasmodium falciparum malaria, excluding those with severe malaria, hepatitis B/C, or recent antimalarial treatment.

04

Endpoints

Primary

  • Recrudescent infections at D28

Secondary

  • Cure rate at Day 28

  • Parasite Clearance Time (Median)

  • Fever Clearance Time (Median)

  • Adequate Clinical and Parasitological Response at D28

  • Recrudescent infections at Day 63

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