Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00988507
Other study ID # DRI10382
Secondary ID
Status Terminated
Phase Phase 2
First received October 1, 2009
Last updated June 27, 2011
Start date October 2009
Est. completion date November 2010

Study information

Verified date June 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Interventional

Clinical Trial 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.


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 follow-up period of 61 days.


Recruitment information / eligibility

Status Terminated
Enrollment 440
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Ferroquine (SSR97193)
Pharmaceutical form: capsule Route of administration: oral
Placebo
Pharmaceutical form: capsule Route of administration: oral
artesunate
Pharmaceutical form: tablets Route of administration: oral

Locations

Country Name City State
Benin Sanofi-Aventis Investigational Site Number 204001 Cotonou
Burkina Faso Sanofi-Aventis Investigational Site Number 854002 Bobo-Dioulasso 01
Burkina Faso Sanofi-Aventis Investigational Site Number 854003 Nouna
Burkina Faso Sanofi-Aventis Investigational Site Number 854001 Ouagadougou
Cameroon Sanofi-Aventis Investigational Site Number 120001 Yaounde
Gabon Sanofi-Aventis Investigational Site Number 266001 B.P. 118 Lambarene
Gabon Sanofi-Aventis Investigational Site Number 266002 Libreville
Kenya Sanofi-Aventis Investigational Site Number 404001 Kilifi
Kenya Sanofi-Aventis Investigational Site Number 404002 Kisumu
Tanzania Sanofi-Aventis Investigational Site Number 834001 Korogwe

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

Benin,  Burkina Faso,  Cameroon,  Gabon,  Kenya,  Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recrudescent infections at D28 in the groups with ferroquine associated with artesunate. Recrudescence is defined as the recurrence of the same original strain of Plasmodium falciparum regardless of clinical symptoms 4 weeks No
Secondary Cure rate at Day 28 4 weeks No
Secondary Parasite Clearance Time (Median). up to 63 days No
Secondary Fever Clearance Time (Median) up to 63 days No
Secondary Recrudescent infections at Day 28 in the ferroquine group in monotherapy 4 weeks No
Secondary Recrudescent infections at Day 63 9 weeks No
Secondary Adequate Clinical and Parasitological Response (ACPR) at D28 4 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT05400655 - Anti-malaria MAb in Kenyan Children Phase 2
Completed NCT02773979 - PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States Phase 1
Completed NCT03660839 - Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria Phase 2
Recruiting NCT05750459 - Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria Phase 4
Completed NCT02020330 - Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day Phase 3
Completed NCT05816330 - L9LS MAb in Malian Adults Phase 2
Completed NCT02353494 - Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria N/A
Completed NCT00744133 - Malaria Challenge With NF54 Strain Phase 1
Active, not recruiting NCT05304611 - Anti-malaria MAb in Malian Children Phase 2
Completed NCT03014258 - A Systems Biology Approach to Malaria Immunity Phase 1
Completed NCT03168854 - Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of Three or Five Administrations of GAP3KO Sporozoites Phase 1
Terminated NCT02497612 - To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria Phase 2
Completed NCT00371189 - Adenovirus Vaccine for Malaria Phase 1
Not yet recruiting NCT05025761 - Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar N/A
Completed NCT00379821 - Chloroquine Alone or in Combination for Malaria in Children in Malawi Phase 3
Completed NCT04329104 - Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali Phase 2
Completed NCT03589794 - rCSP/AP10-602 [GLA-LSQ] Vaccine Trial Phase 1
Completed NCT02780154 - PfSPZ Challenge in Non-immune Adults in Baltimore, USA Phase 1
Completed NCT02143934 - Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity Phase 4
Completed NCT02663700 - Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso Phase 1