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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00529867
Eligibility Criteria:
Inclusion Criteria:
* Children aged between 6 and 59 months
* Minimum body weight of 5kg
* Presence of fever (Temp \>/= 37.5°C) or a history of fever in the last 24 hours
* Presence of asexual P. falciparum monoinfection
* Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood
* Not suffering from severe and complicated forms of malaria
* Able to take drugs under study by the oral route
* Parent or guardian gives informed written consent to participate in study
Exclusion Criteria:
* Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/\<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (\>200,000 µl)
* Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0
* Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
* Patients with vomiting and/or diarrhoea
* Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
* Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions
* Patients with known history of heart disease or arrhythmia
* History of allergy to artemether/lumefantrine or quinine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT00529867
Study Brief:
Protocol Section:
NCT00529867