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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Parasitic Diseases
Protozoan Infections
Artesunate
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014