Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00445796 |
Recruitment Status :
Completed
First Posted : March 9, 2007
Last Update Posted : April 10, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
- clinical and parasitological cure on Day 14
- Secondary: incidence and severity of adverse events

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Cameroon | |
Sanofi-Aventis | |
Yaounde, Cameroon | |
Senegal | |
Sanofi-Aventis | |
Dakar, Senegal |
Study Director: | Valérie Lameyre | Sanofi |
ClinicalTrials.gov Identifier: | NCT00445796 |
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 |
Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Artesunate Amodiaquine Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics |