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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04251351
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female, patients aged 1 to ≤ 14 years
2. Severe P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or positive PfHRP2 rapid diagnostic test (RDT).
Pre-specified modified criteria for severe falciparum malaria
Upon hospital admission, asexual parasitaemia plus at least ONE of the following:
* Glasgow coma score \< 11/15 or Blantyre coma score \<3/5 in pre-verbal children
* Generalized convulsions (≥2 in 24 hours)
* Jaundice (visible jaundice)
* Severe anaemia (HCT \<15%/Hb\<5 g/dL: aged \<12) Severe anaemia (HCT \<20%/Hb\<7 g/dL: aged ≥12)
* Hyperparasitaemia (\>10%)
* Hypoglycaemia (glucose \< 2.2 mmol/L; \<40 mg/dL)
* Kidney dysfunction (blood urea \> 20 mmol/L)
* Acidosis (venous bicarbonate \<15 mmol/L or base excess less than -3.3mEq/L)
* Venous lactate \> 5 mmol/L
* Shock (systolic blood pressure \< 70 mmHg (\<12 years) \<80 mmHg (≥12 years) with cool extremities or capillary refill \>3 seconds)
* Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate\>ULN for age)
* Spontaneous bleeding
* Prostration (inability to set upright, or drink)\* Abbreviations: HCT, haematocrit; Hb, haemoglobin; \*cannot be only severity criteria
3. Temperature \>38°C on admission or fever during the preceding 48 hours.
4. Less than 24 hours of antimalarial therapy
5. Attending caregiver of participant willing and able to give informed consent for participation in the study
Exclusion Criteria:
The participant may not enter the trial if ANY of the following apply:
1. Contraindication or known allergy to paracetamol
2. Known chronic liver disease or tender hepatomegaly
3. Known chronic kidney disease, history of renal replacement therapy or renal biopsy
4. Participants who are already enrolled in another research trial involving an investigational product or have participated to the same study before
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
14 Years
Study:
NCT04251351
Study Brief:
Protocol Section:
NCT04251351