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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT01828333
Eligibility Criteria:
Inclusion Criteria:
Patients (= 2 months old) admitted to one of the study sites and treated for severe malaria with IV quinine in the first part of the study and patients treated with IV/IM artesunate in the second part of the study will be included. Patients need to fulfill the WHO criteria for severe malaria and must be unable to take oral treatment (WHO, 2010, WHO, 2011). In addition all participants need to give their informed consent
Conditions: Positive rapid diagnostic test (RDT) for Plasmodium falciparum HRP2 or lactate dehydrogenase and/or a positive blood slide (thick smear). Patient will be considered to be positive if one of the two tests is positive. In case of negative result of both tests, the patient will not be enrolled in the study and will receive care according to the usual routine practice in the hospital/health center in question.
Definition of severe malaria according to WHO (WHO, 2010): In a patient with P. falciparum asexual parasitaemia and no other obvious cause for the symptoms, the presence of one or more of the following clinical or laboratory features classifies the patient as suffering from severe malaria:
Clinical features (hospitals and health centers):
* impaired consciousness or unrousable coma
* prostration, i.e. generalized weakness so that the patient is unable walk or sit up without assistance
* failure to feed
* multiple convulsions - more than two episodes in 24 h
* deep breathing, respiratory distress (acidotic breathing)
* circulatory collapse or shock, systolic blood pressure \< 70 mm Hg in adults and \< 50 mm Hg in children
* clinical jaundice plus evidence of other vital organ dysfunction
Complementary Laboratory findings (hospitals only)
* severe anaemia (Hb \< 5g/dl, packed cell volume \< 15%)
* hypoglycemia (blood glucose \< 2.2 mmol/l or \< 40 mg/dl)
* metabolic acidosis (plasma bicarbonate \< 15 mmol/l)
* serum creatinine \> 265 ìmol/l suggesting renal impairment
Exclusion Criteria:
Patients with known serious adverse reactions to quinine and artemisinin derivatives or patients who have received adequate antimalarial treatment 24 hours before admission will not be included in the study.
Women with known or suspected pregnancy in all trimesters will not be included in the study and will be treated with quinine infusions according to the new national DRC guidelines (Programme Nationale de Lutte contre le Paludisme, 2012). According to current routine procedures determination of pregnancy will be done by medical anamnesis and/ or by a positive pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT01828333
Study Brief:
Protocol Section:
NCT01828333