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 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

Genetic and Rare Diseases Information Center resources: 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


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

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


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

Additional relevant MeSH terms:


Malaria Protozoan Infections Parasitic Diseases Artesunate Amodiaquine	Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials

ClinicalTrials.gov processed this record on August 16, 2017

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