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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT01936766
Eligibility Criteria:
Inclusion Criteria:
A. Severe Malaria
1. Any level of asexual form of P. falciparum parasitemia on blood smear
2. Severe malaria with one or more of the following:
i. Cerebral malaria (GCS \< 11). ii. Renal impairment (Creatinine \> 2mg/dL or Anuria) iii. Hypoglycaemia (Glucose \< 40mg/dL) iv. Systolic blood pressure \< 80mmHg with cool extremities v. Pulmonary edema vi. Venous bicarbonate \< 15mmol/L vii. Venous lactate \> 4mmol/L
3. Age 16-65 years
4. Written informed consent obtained from patient or attending relative.
B. Severe Sepsis
1. Negative blood smear for any Plasmodium species
2. Clinical signs of infection with two of following:
i. Heart rate \> 90/min ii. Respiratory rate \> 20/min iii. Body temperature \>38°C or \<36°C iv. White blood cell count of \> 12000/μL or \< 4000/μL
3. Severe sepsis with one or more of the following due to infection:
i. Systolic blood pressure \< 90mmHg despite fluid resuscitation ii. Lactate \> 4mmol/L iii. Urine output \< 0.5mL/kg/hour for \> 2 hours despite fluid resuscitation iv. Acute lung injury with PaO2/FiO2 \< 250 in the absence of pneumonia v. Acute lung injury with PaO2/FiO2 \< 200 in the presence of pneumonia vi. Creatinine \> 2mg/dL vii. Bilirubin \> 2mg/dL viii. Platelet count \< 100000/μL
4. Age 16-65 years
5. Written informed consent obtained from patient or attending relative
Exclusion Criteria:
A. Severe Malaria
1. Patient or relative unable or unwilling to give informed consent
2. Serious pre-existing disease The following exclusion criteria described below are applied to patient for whom invasive hemodynamic monitoring will be performed.
3. Spontaneous bleeding or platelet count \< 30000/μL on enrollment
4. Pregnancy.
5. Contraindication or unsuitable condition for thermodilution technique
B. Severe Sepsis
1. Patient or relative unable or unwilling to give informed consent
2. Serious pre-existing disease The following exclusion criteria described below are applied to patient for whom invasive hemodynamic monitoring will be performed.
3. Spontaneous bleeding or platelet count \< 30000/μL on enrollment
4. Pregnancy.
5. Contraindication or unsuitable condition for thermodilution technique
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT01936766
Study Brief:
Protocol Section:
NCT01936766