Clinical trial NCT00563914: A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
Official title: An Open Label, 4 Escalating Dose, Randomized Multicentre Study Evaluating the Safety and Activity of Ferroquine Associated With Artesunate Versus a Positive Calibrator (Amodiaquine Associated With Artesunate) in African Adult Patients With Uncomplicated Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malaria
Keywords: Malaria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria.

The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.

Detailed description: The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.

Eligibility criteria: Inclusion Criteria:

* Body weight between 50 kg and 90 kg with Body Mass Index \>18 kg/m²
* 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:

* Hypersensitivity to quinoleines or artesunate
* 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.

Primary outcomes:
measure: Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
timeFrame: Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
Secondary outcomes:
measure: Parasite clearance assessed by repeated measurements of parasitemia
timeFrame: Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28
measure: Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
timeFrame: up to 28 days after last dosing
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Sanofi-Aventis Administrative Office
city: Nairobi
country: Kenya
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon
name: Christian Supan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.