Lung Ultrasound in Children With Severe Malaria (NCT04176029) | Clinical Trial Compass
CompletedNot Applicable
Lung Ultrasound in Children With Severe Malaria
Democratic Republic of the Congo124 participantsStarted 2019-12-09
Plain-language summary
A prospective cohort study, with 171 children admitted for severe malaria that will be included in the cohort. The study will take place in Kinshasa, Democratic Republic of Congo.
The primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses that can be facilitated by the use of LUS (normal lung or acidotic breathing, ARDS, concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).
Who can participate
Age range
1 Year – 14 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.
Inclusion Criteria:
* Children aged between 1 and 14 years;
* Admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity criteria detailed below).
* Informed consent signed
Clinical features of severe malaria
* Cerebral malaria; A Glasgow Coma Scale of less than 11 or a Blantyre coma scale less than 3 in preverbal children
* Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate \> upper normal limit for age)
* Jaundice (visible jaundice)
* Circulatory collapse or shock: age \<12 systolic blood pressure \< 70mm Hg; age \> 12 systolic blood pressure \<80mm Hg with cool extremities or capillary refill time \>3 seconds
* Spontaneous bleeding
* Multiple generalized convulsions: more than two episodes within 24h
* Prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance
Laboratory features and other findings
* Metabolic acidosis (venous plasma bicarbonate \< 15mmol/l or base excess \< -2.2mEq/L)
* Severe anaemia (age \<12: hematocrit \< 15% or haemoglobin \< 5g/dl; age\>12: hematocrit \< 20% or hemoglobin \< 7 g /dl)
* Hypoglycaemia (\< 2.2mmol/l or \< 40mg/dl)
* Hyperparasitaemia defined as \> 10%
* Hyperlactataemia (venous lactate \< 5 mmol/L)
* Kidney dysfunction (blood urea \>20mmol/L)
Exclus…
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.