Status:
TERMINATED
Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Lead Sponsor:
Sanofi
Conditions:
Plasmodium Falciparum Infection
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 -...
Detailed Description
The overall study duration is 64 days, consisting of a screening period (less or equal 1 day), of a 3-day treatment period during which the patient is hospitalized for a maximum of 60 hours, and a fol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00988507
Start Date
October 1 2009
End Date
November 1 2010
Last Update
June 28 2011
Active Locations (10)
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1
Sanofi-Aventis Investigational Site Number 204001
Cotonou, Benin
2
Sanofi-Aventis Investigational Site Number 854002
Bobo-Dioulasso, Burkina Faso
3
Sanofi-Aventis Investigational Site Number 854003
Nouna, Burkina Faso
4
Sanofi-Aventis Investigational Site Number 854001
Ouagadougou, Burkina Faso