NCT00452907

Brief Summary

Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

1.9 years

First QC Date

March 27, 2007

Last Update Submit

February 16, 2010

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

  • Clinical and parasitological cure rate

    at day 28

  • Clinical and biological tolerability

    During the study period

Study Arms (3)

1

EXPERIMENTAL

Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment

Drug: Artesunate

2

ACTIVE COMPARATOR

Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os

Drug: Artesunate + Sulfadoxine-Pyrimethamine

3

ACTIVE COMPARATOR

Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days

Drug: arthemether + lumefantrine

Interventions

ArtesunateDRUG

oad, per os, 3 days of treatment

1
Artesunate + Sulfadoxine-PyrimethamineDRUG

oad, per os

2
arthemether + lumefantrineDRUG

bid, per os. Duration of treatment: 3 days

3

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Body weight \> 5kg
  • Residence in the investigator site area for the duration of the trial
  • Axillary temperature ≥ 37,5°C at Day 0
  • Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood

You may not qualify if:

  • Danger signs or signs of severe malaria
  • Other severe illnesses
  • Allergy to one of the drugs
  • Pregnant women
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Bougoula, Mali

Location

MeSH Terms

Conditions

Malaria

Interventions

Artesunatesulfadoxine-pyrimethamine-artesunateLumefantrine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic 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 27, 2007

First Posted

March 28, 2007

Study Start

July 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

MA(1)