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:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03217851
Eligibility Criteria:
Inclusion Criteria:
* Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
* Written informed consent obtained (by parents/guardian in case of children less than 18 years old)
Exclusion Criteria:
Patients presenting signs of severe malaria\* will be excluded from the survey to prevent any delay in the management of the patient.
\*Guideline for the treatment of Malaria-3rd edition, WHO (27) Severe falciparum malaria is defined as one or more of the following, occurring in the absence of an identified alternative cause and in the presence of P.falciparum asexual parasitaemia.
* Impaired consciousness: A Glasgow comma score \< 11 in adults or Blantyre coma score \< 3 in children
* Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance.
* Multiple convulsions: More than two episodes within 24 h
* Acidosis: A base deficit of \> 8 mEq/L or, if not available a plasma bicarbonate level of \< 15 mmol/L or venous plasma lactate ≥ 5 mmol/L. Severe acidosis manifests clinically as respiratory distress (rapid, deep, laboured breathing).
* Hypoglycaemia: Blood or plasma glucose \< 2.2 mmol/L (\<40 mg/dL)
* Severe malarial anaemia: Haemoglobin concentration ≤ 5 g/dL or a haematocrit of ≤ 15% in children \< 12 years of age (\< 7 g/dL and \< 20%, respectively, in adults) with a parasite count \> 10,000/µL
* Renal impairment: Plasma or serum creatinine \> 265 µmol/L (3 mg/dL) or blood urea \> 20 mmol/L
* Jaundice: Plasma or serum bilirubin \> 50 µmol/L (3 mg/dL) with a parasite count \> 100,000/ µL
* Pulmonary oedema: Radiologically confirmed or oxygen saturation \< 92% on room air with a respiratory rate \> 30/min, often with chest indrawing and crepitations on auscultation
* Significant bleeding: Including recurrent or prolonged bleeding from the nose, gums or venepuncture site; haematemesis or melaena
* Shock: Compensated shock is defined as capillary refill ≥ 3 s or temperature gradient on leg (mid to proximal limb), but no hypotension. Decompensated shock is defined as systolic blood pressure \< 70 mm Hg in children or \< 80 mm Hg in adults, with evidence of impaired perfusion (cool peripheries or prolonged capillary refill)
* Hyperparasitaemia: P.falciparum parasitaemia \> 10%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
75 Years
Study:
NCT03217851
Study Brief:
Protocol Section:
NCT03217851