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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT02640495
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged over 6 months old
* Acute severe P. falciparum malaria or another indication to treat with IV artesunate. 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:
* Prostration OR obtundation
* BCS\<3 (preverbal children) or GCS\<11 (adults)
* Convulsion in last 24 hours
* Suspected acidosis, manifesting as acidotic breathing
* Respiratory distress manifesting clinically (nasal flaring/indrawing) or oxygen saturation \<92% or respiratory rate \>30/min
* History of anuria
* Jaundice and/or hemoglobinuria
* Hemoglobin \<7 g/dl or hematocrit \<20%
* Significant bleeding including recurrent or prolonged bleeding from nose gums or venipuncture sites; hematemesis or melena
* Shock defined as systolic blood pressure \<70 mm Hg (children) OR \<80 mm Hg (adults)
* P. falciparum parasitaemia \>10%
* Indication for parenteral antimalarial treatment (as assessed by clinician) other than nausea and vomiting. These may include laboratory findings such as:
* Creatinine \>2.5 mg/dL (\>220uM/L) or blood urea \>56mg/dL (\>20 mM/L)
* Glucose \<4.0 mmol/L (\<72mg/dL)
* Bilirubin \> 3 mg/dL (\>50uM/L)
* Hemoglobin \<7g/dL or Hematocrit \<20%
* P. falciparum parasitaemia \>4%
* Venous plasma lactate \>5 mM, Base deficit of \>8meq/L or bicarbonate \<15mM
* Written informed consent or consent by locally accepted representative in the case of patients rendered incapable of providing consent due to illness
Exclusion Criteria:
* History of 2 or more doses of parenteral antimalarial treatment in the previous 24 hours
* History of allergy or known contraindication to artemisinins
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT02640495
Study Brief:
Protocol Section:
NCT02640495