Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment.

Secondary objectives:

• To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.

• To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone.

• To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Artemisinins; Artesunate; Ferroquine

Criteria

Inclusion Criteria:

• 3 cohorts enrolled in sequence with data interim review by Data Monitoring Committee (DMC) between cohort 1-2 and cohort 2-3

• Cohort 1 : Adults > 50 kg or Adolescents >30 kg and age > or = 14 years

• Cohort 2 : Children with body weight [30 kg- 15 kg[

• Cohort 3 : Children with body weight [15 kg-10 kg]

• Age related Body Mass Index (BMI)> or = 5 th percentile.

• Presence of body temperature > or = 37.5°C or history of fever in the last 24 hours.

• Monoinfection with Plasmodium falciparum with parasitemia from 1,000/microL to 200,000/microL.

• Signed Informed Consent Form by the patient (if the patient is > or = age defining majority) or by the parents or legal guardian of minor patients (<18 years of age or < other age locally defining majority). In addition, participants with capacity for writing will sign off on an Assent Form. Patients with no capacity for writing will have the Assent Form read. In that case, an impartial witness will certify the document was read to the child.

Exclusion Criteria:

• Presence of HBs antigen and of anti-HCV antibodies

• Laboratory parameters with clinical significant abnormalities and/or reaching critical values : Hemoglobin (< 7g/dl), hematocrit, red blood cell count, white blood cell, reticulocytes, platelets, glucose, creatinine, aspartate transferase (AST), alanine transferase (ALT > 3 ULN), alkaline phosphatase, total bilirubine > 1.5 ULN.

• History or presence of any clinically significant disease or symptoms which might confound the interpretation of the safety and efficacy information.

• Splenectomized patients.

• Presence of criteria for complicated malaria

• Patients unable to drink

• Breastfeeding patients.

• Permanent vomiting.

• Female participants with child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g. implants, oral contraceptives, some intra-uterine devices or a double barrier method). The need for an efficient method will be reminded to the patient and the patient's legal guardian(s) by the investigator.

• Previous treatment within 5 times the elimination half-life or within the last 14 days, whichever the longest :

• with any anti-malaria agents i.e., quinine, chloroquine, amodiaquine, mefloquine, halofantrine, sufladoxine-pyrimethamine, doxycycline-pyrimethamine, primaquine, artemether, atovaquone, proguanil, lumefantrine,

• with an other investigational drug

• with 2D6 main substrates

• Past or concomitant participation in a study with an anti-malaria vaccine.

• Measles vaccine injection within the last 15 days.