Severe and Cerebral Malaria Investigated Through Host Metabolomics (NCT02451904) | Clinical Trial Compass
CompletedNot Applicable
Severe and Cerebral Malaria Investigated Through Host Metabolomics
Bangladesh840 participantsStarted 2015-06
Plain-language summary
* The aim is to describe disease mechanisms of severe and cerebral malaria and identify new targets for adjunctive therapies.
* Despite treatment between 10-30% of patients with severe malaria die.
* Metabolic acidosis and cerebral malaria are major complications associated with mortality across all age groups. Still, their underlying pathogenesis remains incompletely understood.
* Using a metabolomics approach, this study aims to characterise the spectrum of acids accumulating during acidosis, and investigate patterns of metabolic dysregulation associated with coma and seizures.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 f…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterisation of patterns of metabolic dysregulation in severe malaria