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

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ClinicalTrials.gov Identifier: NCT00445796
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Malaria Drug: Artesunate Drug: Amodiaquine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. clinical and parasitological cure on Day 14
  2. Secondary: incidence and severity of adverse events

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445796


Locations
Cameroon
Sanofi-Aventis
Yaounde, Cameroon
Senegal
Sanofi-Aventis
Dakar, Senegal
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Lameyre Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00445796     History of Changes
Other Study ID Numbers: PM_L_0163
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Amodiaquine
 Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials