Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00699920
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT00699920
Study Brief:
Protocol Section:
NCT00699920