Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00445796
First received: March 8, 2007
Last updated: April 8, 2008
Last verified: April 2008
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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:
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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 |
| Health Authority: | Senegal: Ministere de la sante |
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 September 28, 2016