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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03641534
Eligibility Criteria:
Inclusion Criteria:
I. Sepsis criteria:
The sepsis criteria include the severe sepsis and septic shock categories according to 2012 Surviving Sepsis Campaign guidelines. Due to a possible delay in obtaining all the enrolment sequential organ failure assessment (SOFA) score variables necessary to fulfil the criteria for the latest 2016 sepsis definition, the 2012 Surviving Sepsis Campaign criteria and the quick SOFA tool will be used for inclusion. However, after study completion, when all admission SOFA scores will be available, all patients will be re-scored according to the Sepsis 3 definition.
Inclusion criteria for sepsis:
1. Documented or suspected infection
2. Systolic blood pressure ≤ 100 mmHg, or receiving vasopressor (epinephrine, norepinephrine, dopamine)
PLUS one or more of the following:
A. Respiratory rate ≥22 breaths per minute or under oxygen therapy or mechanical ventilation B. Altered mental status (Glasgow Coma Scale ≤ 14)
3. Fully informed written consent obtained, including written informed consent from a relative or parent/guardian in case of reduced consciousness and/or age \< 16 years.
4. Age ≥12 years
5. Negative peripheral blood slide for any stages of malaria parasites and a negative rapid diagnostic test (RDT) for falciparum and vivax malaria.
6. Within 24 hours of hospital or ICU admission
Note: Positive blood or urine cultures not required as eligibility criteria due to limited microbiology laboratory availability.
II. Severe malaria criteria Using modified World Health Organization criteria for severe falciparum malaria, as defined previously.
* Any P. falciparum or P. vivax parasitaemia in adults, detected by asexual stages on a peripheral blood- slide or a positive RDT in combination with one or more:
i. GCS \<11 ii. Hematocrit \< 20% with parasite count \>100,000/mm3 iii. Jaundice with parasite count \>100,000/mm3 iv. Serum creatinine \>3 mg/dL (or anuria) v. Hypoglycemia with venous glucose \<40 mg/dL vi. Systolic blood pressure \<80 mmHg with cool extremities vii. Peripheral asexual stage parasitemia \>10 % viii. Peripheral venous lactate \>4 mmol/L ix. Peripheral venous bicarbonate \<15 mmol/L x. Respiratory distress/pulmonary edema: radiologically confirmed, or oxygen saturation \<92% on room air with a respiratory rate \>30/min, often with chest indrawing and crepitations on auscultation xi. Spontaneous bleeding xii. Generalized convulsions (≥2 in 24 hours)
* Fully informed written consent obtained, including written informed consent from relative or parent/guardian in case of reduced consciousness and/or age \< 16 years.
* Age ≥12 years
* Within 24 hours of antimalarial treatment
III. Uncomplicated malaria criteria (control group)
* P. falciparum slide positive (asexual stages) on peripheral blood slide or positive RDT in combination with none of the above severity criteria.
* Within 24 hours of start of antimalarial treatment
* Fully informed written consent obtained, including written informed consent from relative or parent/guardian in case of reduced consciousness and/or age \< 16 years.
* Age ≥12 years
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
* Patients admitted with known malignancy or liver disease
* Recent surgery (as part of current admission)
* Trauma (resulting in current admission)
* Antimalarial treatment ≥24 hours prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03641534
Study Brief:
Protocol Section:
NCT03641534