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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02451904
Eligibility Criteria:
Severe/Cerebral Malaria:
* Any P. falciparum parasitaemia detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test in combination with one or more Modified WHO Criteria for Severe Malaria (Hien et al, 1996)
* \< 24 hours after treatment commencement with either parenteral artemisinin or quinine
* Age \> 12 years
* Full informed written consent obtained
Uncomplicated malaria:
* Any level of Plasmodium parasitaemia, detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test without any of the complications of severe malaria stated above.
* Age \> 12 years
* Full informed written consent obtained
Sepsis:
* Clinical signs of infection in combination with any two of the following signs:
1. Heart rate \> 90 beats per minute;
2. Respiratory rate \> 20 breaths per minute, a PaCO2 of \< 32 mmHg, or the use of mechanical ventilation for an acute respiratory process;
3. Tympanic temperature \> 38°C or \< 36 °C;
4. White-cell count of \> 12x109/L or \< 4x109/L, or a differential count showing 10% immature neutrophils ;
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria
* \[As bacterial culture is not routinely available at the study site, positivity of cultures is not required\]
* Age \> 12 years
* Full informed written consent obtained
Acidosis:
* Clinical suspicion of metabolic acidosis in combination with any of the following:
1. Peripheral venous bicarbonate \< 15 mmol/L
2. Peripheral venous base excess \< -3 mmol/L
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria; and not meeting any of the inclusion criteria for sepsis as stated above.
* Age \> 12 years
* Full informed written consent obtained
Encephalitis:
* GCS \< 11/15
* Documented fever \> 38°C
* Onset of symptoms \< 2 weeks, with an indication a lumbar puncture as part of the diagnostic work up
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria
* Age \> 12 years
* Full informed written consent obtained
Healthy volunteers:
* No chronic or acute disease
* No fever in the past 2 weeks
* Age \> 16 years
* Full informed written consent obtained
Exclusion Criteria:
* Known pre-existing chronic medical conditions including advanced hepatic disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02451904
Study Brief:
Protocol Section:
NCT02451904