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Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00445796
First received: March 8, 2007
Last updated: April 8, 2008
Last verified: April 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Sanofi:

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
Investigators
Study Director: Valérie Lameyre Sanofi
  More Information

No publications provided

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

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on May 16, 2013