A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
NCT ID: NCT00563914
Last Updated: 2009-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2007-10-31
2008-11-30
Brief Summary
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The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
ferroquine (SSR97193)
associated with artesunate
2
amodiaquine
associated with artesunate
Interventions
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ferroquine (SSR97193)
associated with artesunate
amodiaquine
associated with artesunate
Eligibility Criteria
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Inclusion Criteria
* Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
* Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL
Exclusion Criteria
* History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
* Splenectomized patients
* Laboratory parameters outside normal ranges
* Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1\&2 antibodies
* Cardio vascular and Electrocardiogram parameters outside normal values
* Presence of criteria of complicated malaria
* Permanent vomiting
* Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
* Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
* History of drug or alcohol abuse (alcohol consumption \> 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
* Intention to use herbal medicine during the study period
* Immunization injection within last 15 days
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
65 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Christian Supan, MD
Role: PRINCIPAL_INVESTIGATOR
URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon
Locations
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Sanofi-Aventis Administrative Office
Lambaréné, , Gabon
Sanofi-Aventis Administrative Office
Nairobi, , Kenya
Countries
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References
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Supan C, Mombo-Ngoma G, Kombila M, Ospina Salazar CL, Held J, Lell B, Cantalloube C, Djeriou E, Ogutu B, Waitumbi J, Otsula N, Apollo D, Polhemus ME, Kremsner PG, Walsh DS. Phase 2a, Open-Label, 4-Escalating-Dose, Randomized Multicenter Study Evaluating the Safety and Activity of Ferroquine (SSR97193) Plus Artesunate, versus Amodiaquine Plus Artesunate, in African Adult Men with Uncomplicated Plasmodium falciparum Malaria. Am J Trop Med Hyg. 2017 Aug;97(2):514-525. doi: 10.4269/ajtmh.16-0731. Epub 2017 Jul 19.
Other Identifiers
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SSR97193
Identifier Type: -
Identifier Source: secondary_id
ACT10420
Identifier Type: -
Identifier Source: org_study_id