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Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00445796
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: Artesunate
Drug: Amodiaquine
Phase IV

MedlinePlus related topics: Malaria
Drug Information available for: Artesunate Amodiaquine Amodiaquine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • clinical and parasitological cure on Day 14
  • Secondary: incidence and severity of adverse events

Estimated Enrollment: 300
Study Start Date: June 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445796

Locations
Cameroon
Sanofi-Aventis
Yaounde, Cameroon
Senegal
Sanofi-Aventis
Dakar, Senegal
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Valérie Lameyre Sanofi-Aventis
  More Information

clinicalstudyresults.org  This link exits the ClinicalTrials.gov site

Study ID Numbers: PM_L_0163
Study First Received: March 8, 2007
Last Updated: April 8, 2008
ClinicalTrials.gov Identifier: NCT00445796  
Health Authority: Senegal: Ministere de la sante

Study placed in the following topic categories:
Artesunate
Protozoan Infections
Amodiaquine
Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009