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Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

NCT ID: NCT00445796

Last Updated: 2008-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Artesunate

Intervention Type DRUG

Amodiaquine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Principal Investigators

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Valérie Lameyre

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Yaoundé, , Cameroon

Site Status

Sanofi-Aventis

Dakar, , Senegal

Site Status

Countries

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Cameroon Senegal

Other Identifiers

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PM_L_0163

Identifier Type: -

Identifier Source: org_study_id