An observational study in Severe Malaria, sponsored by University of Kinshasa. Completed at 1 site in Democratic Republic of the Congo. Open to participants aged 2 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by University of Kinshasa · Observational
The goal of this observational study is to optimize the management of severe childhood malaria, based on understanding and controlling the severity factors of the disease in Congolese children aged 2 to 9 years (the age group at risk of developing various severe forms of malaria), admitted to the paediatric intensive care units (PICU).
The main question it aims to answer is whether the scores or models used to predict the severity of severe malaria and the associated risk of mortality accurate enough to warrant early interventions, including treatments, on their own?
Thus, investigators aim to fill three knowledge gaps associated with the following hypotheses:
Hypothesis-1: Children with severe malaria show signs of disease severity based on their severity scores on admission. Higher severity scores on admission are associated with a higher risk of mortality.
Hypothesis-2: Validation of the predictive power and transferability of severe malaria severity scores to additional independent populations is needed to support their clinical utility.
Hypothesis-3: The severity of the clinical and biological changes induced by plasmodium depends not only on the ability of the parasite to invade and grow in the host organism, but also and above all on the number of parasites present in the host (parasitemia).
For any child admitted to the PICU and meeting the inclusion criteria, as part of clinical care, investigators proceeded before any treatment:
Then, the diagnostic parameters of acid-base disorders will be calculated, including AG (anion gap), AGCAP (AG corrected for albumin and phosphate plasmatic concentrations), SIG (Strong ion gap), SBE (Standard base excess) and SBDCAP (Standard base deficit corrected for albumin and phosphate plasmatic concentrations).
Background:
Severe malaria has associated with a high risk of paediatric hospital mortality in resource-constrained countries, which remains deplorable. Improved methods of risk-stratification can assist in referral decision making and resource allocation. Investigators aim to i) create prediction model for in-hospital mortality risk among children presenting with severe malaria and compare its predictive performance to the current models, ii) validate the latter, and iii) assess the plasmodium-induced changes in clinical and biological parameters.
Methods:
This is a retrospective study of data collected prospectively during a period from January 30, 2017 to August 01, 2025, from children with severe malaria, admitted to the PICU of the Monkole Hospital Center (MHC) and the Kimbondo Pediatric Center (KPC), all in Kinshasa, DR. Congo. Baseline clinical and laboratory variables were collected on enrolled children. The primary outcome is death up to 1 week post-admission, and the second outcome, the length of stay in pediatric intensive care following admission for severe malaria. Machine learning algorithms will be employed to accomplish the three specific research objectives.
Expected Results:
In line with research objectives, the following results are expected:
A novel model for predicting associated mortality risk of severe malaria will be developed:
This novel model will be based on predictors of disease severity and will measure:
Together, research data will provide proof of principle supporting early interventions and treatment choices in children presenting with severe malaria.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 100 is below the median of 600 across 218 observational studies indexed under Malaria.
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Children with severe malaria, admitted to the pediatric intensive care units of the Monkole Hospital Center (MHC) and the Kimbondo Pediatric Center (KPC), all in Kinshasa, DR. Congo.
I) Inclusion Criteria:
-Admission to the pediatric intensive care unit (PICU) for severe malaria, as defined by the World Health Organization (WHO) criteria.
Definitions:
Severe malaria was defined by the presence of at least one major clinical manifestation, including:
II) Exclusion Criteria:
Children aged 2 to 9 years, admitted to the paediatric intensive care units for severe malaria
Diagnostic Test: Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry
1. The puncture of the radial artery was made for the instant arterial blood gaz as well as for venous biochemistry 2. The one-drop finger pulp blood test was made for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum
The primary outcome is death during hospitalization for severe malaria [From day 1 of admission to the pediatric intensive care unit (PICU) up to day 7 post-admission]
Death was defined as a categorical variable, defining patients who died and those who survived.
Time frame: Day 7
The secondary outcome is survival time, defined as the interval between hospital admission and death occurring during the hospitalization period [From day1 of admission until death/recovery (discharge from hospital), assessed up to day7 post-admission]
Survival Time was defined as the interval between hospital admission for severe malaria and death occurring during the hospitalization period. The hospitalization period extended from day 1 of admission to death (for non-survivors) or discharge (for survivors). Patients who were still alive at the end of the hospitalization period of up to day 7 (follow-up period for each patient = 7 days) or those lost to follow-up were considered censored.
Time frame: From day 1 of admission to the PICU until death or recovery (discharge from hospital), assessed up to day 7 post-admission.
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University of Kinshasa