A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
December 18, 2009 updated by: Sanofi
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
associated with artesunate
|
|
Active Comparator: 2
|
associated with artesunate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
Time Frame: Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
|
Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parasite clearance assessed by repeated measurements of parasitemia
Time Frame: Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28
|
Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28
|
|
Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
Time Frame: up to 28 days after last dosing
|
up to 28 days after last dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Supan, MD, URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
November 22, 2007
First Submitted That Met QC Criteria
November 22, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
December 21, 2009
Last Update Submitted That Met QC Criteria
December 18, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT10420
- SSR97193
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.