Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks (SMART-CURE)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: Coartem

Drug: Coarsucam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00699920

ARAMF_L_02661

Details and patient eligibility

About

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 first malaria attack of each patient.

Secondary objectives:

For the first attack:

To compare the 2 groups of treatment in terms of:

Day 42 efficacy
Parasitological and fever clearance
Clinical and Biological tolerability
Evolution of gametocyte carriage

For attack 2nd and following:

To compare the 2 groups of treatment in terms of:

Day 28 and Day 42 clinical and parasitological effectiveness
Clinical and Biological tolerability
Proportion of patients without fever at Day 3
Proportion of patients without parasites at Day 3
Evolution of gametocyte carriage
Compliance

During the total follow up of the cohort:

To compare the 2 groups of treatment in terms of:

Treatment incidence density
Impact of repeated treatment on clinical and biological tolerability
Impact on anaemia
Impact on Hackett score.

Enrollment

413 patients

Sex

All

Ages

6 to 59 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.