ACT MALI: Treatment of Malaria Based on Combination Thera... | NCT00452907

Studies
ACT MALI: Treatment of Malaria Based on Combination Therapies

NCT00452907

Sponsor

Sanofi

Status

Completed

Last Update Posted

Feb 17, 2010Estimated

Enrollment

780Actual

Phase

Phase 4

Conditions

Malaria

Interventions

Artesunate
Artesunate + Sulfadoxine-Pyrimethamine
arthemether + lumefantrine

Countries

Mali

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Mar 27, 2007

First Submission Date that Met QC Criteria

Mar 27, 2007

First Posted Date

Mar 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2010

Last Update Posted Date

Feb 17, 2010Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

780Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Artesunate	Drug	oad, per os, 3 days of treatment	1
Artesunate + Sulfadoxine-Pyrimethamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical and parasitological cure rate		at day 28
Clinical and biological tolerability		During the study period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valérie Lameyre	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bougoula			Mali

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077332	Artesunate
C578917	sulfadoxine-pyrimethamine-artesunate
D000078102	Lumefantrine

Ancestor Terms

ID	Term
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided