Status:
COMPLETED
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
Lead Sponsor:
Sanofi
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the f...
Eligibility Criteria
Inclusion
- Specific inclusion criteria for initial enrollment:
- Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,
- Inclusion criteria for each attacks:
- Body weight ≥5 kg
- Able to be treated by oral route
- Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
- Confirmed Plasmodium falciparum infection with positive paratesimia
- Haemoglobin value ≥5.0 g/dl
Exclusion
- Specific exclusion criteria for initial enrollment:
- Patient participating in another ongoing clinical trial
- Allergy to one of the investigational medicinal products
- History of hepatic and (or) haematological impairment during treatment with amodiaquine
- History of cardiac disease
- Concomitant febrile illness
- Exclusion criteria for each attacks:
- Presence of at least one danger sign of malaria: recent history of convulsions (1-2 within 24h), unconsciousness state, lethargy, unable to drink or breast feed, vomiting everything, unable to stand/sit due to weakness
- Severe concomitant disease or known disturbances of electrolyte balance such as hypokalaemia or hypomagnesaemia
- Intake of medication metabolized by cytochrome CYP 2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) at the time of inclusion
- Intake of drugs known to inhibit CYP 2A6 (e.g. methoxsalem, pilocarpine, tranylcypromine) and/or 2C8 cytochromes (e.g. trimethoprim, ritonavir, ketoconazole, montelukast, gemfibrozil) at the time of inclusion
- Intake of medication known to prolong the QTc interval, such as class IA and III antiarrythmics, neuroleptics, antidepressant agents, certain antibiotics including drugs in the macrolide class, fluoroquinolones, imidazole and triazole, antifungal agents, certain non-sedative anthistamines (terfenadine, astemizole) and cisapride at the time of inclusion
- Patient having received artesunate + amiodaquine or artemether + lumefantrine at suitable dosage within the previous 2 weeks.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00699920
Start Date
June 1 2008
End Date
June 1 2010
Last Update
June 29 2010
Active Locations (1)
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1
Sanofi-aventis administrative office
Kampala, Uganda