NCT00445796

Brief Summary

Primary Objective: To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes. Secondary Objective: To compare the clinical safety of the two treatment regimens.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

March 8, 2007

Last Update Submit

April 8, 2008

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

  • clinical and parasitological cure on Day 14

  • Secondary: incidence and severity of adverse events

Interventions

ArtesunateDRUG
AmodiaquineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • weighing ≥ 10 kg
  • residing in the area covered by the investigating centre throughout the entire follow-up period
  • axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours
  • Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre

You may not qualify if:

  • presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure \< 70 mmHg in adults or \< 50 in children, spontaneous bleeding, inability to sit or stand
  • serious concomitant disease
  • allergy to one of the investigational medicinal products
  • pregnant women or breast-feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis

Yaoundé, Cameroon

Location

Sanofi-Aventis

Dakar, Senegal

Location

MeSH Terms

Conditions

Malaria

Interventions

ArtesunateAmodiaquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Valérie Lameyre

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 9, 2007

Study Start

June 1, 2005

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

CA(1)SE(1)