Severe MalariaNCT07355426
Clinical Prediction Models for Pediatric In-Hospital Death Risk in Congolese Severe Malaria Children Using Machine Learning Based-Algorithms
An observational study of Severe Malaria, run by University of Kinshasa at 1 site in Democratic Republic of the Congo.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Severe Malaria
- What is being tested?
- Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry
- How many people
- 100 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 30 Jan 2017to 30 Aug 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
- 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:
- Coma
- Repeated seizures (≥ 2 episodes within 24 hours)
- Neurological disorders
- Respiratory distress
- Liver failure
- Dark ("Coca-Cola") urine
- Jaundice
- Renal failure (anuria)
- Severe anaemia (Hb ≤ 5 g/dL)
- Bleeding abnormalities
- Circulatory collapse or systolic blood pressure < 50 mmHg
- Data collection periods varied by health zone and clinical unit. However, within each zone, all consecutively admitted patients during the study period were included.
II) Exclusion Criteria:
- Another medical condition (non-parasitic infection or other) capable of causing anemia or similar abnormalities.
- Comorbidities that could interfere with the clinical presentation or outcomes of severe malaria.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kinshasa
Kinshasa, Kinshasa City
About this study
Official title: Pediatric In-Hospital Mortality Risk in Congolese Children With Severe Malaria: Derivation of Clinical Prediction Models Using Machine Learning Based-Algorithms
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?
Read more
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:
- An arterial blood sample of 3 ml by puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry, including albumin, phosphate, chlorine, magnesium, urea, creatinine and total bilirubin dosages, and,
- A one-drop finger pulp blood test for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum.
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).
Read the detailed description
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:
- The prevalence of Multiple Organ Dysfunction Syndrome (MODS) and metabolic acidosis in children presenting with severe malaria will be determined.
- 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:
- The degree of severity of MODS and metabolic acidosis.
- The length of stay for severe malaria in the PICU
- The risk of death following hospitalization for severe malaria
- The influence of parasitemia on disease severity
- The performance of the proposed novel model will be measured
- The predictive nomogram and scoring system will be associated with it.
- Investigators validate and compare the performance of existing models for predicting severe malaria severity against the proposed novel model.
Together, research data will provide proof of principle supporting early interventions and treatment choices in children presenting with severe malaria.
- Conditions
- Severe Malaria
- Being tested
- Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry
- Keywords
- Severe malaria, Paediatric in-hospital mortality risk, Machine learning-based algorithms, Predictive model, Plasmodium falciparum, Multiple Organ Dysfunction Syndrome (MODS), Metabolic acidosis
- Medical subject headings
- Malaria, Malaria, Falciparum, Multiple Organ Failure, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistryDiagnostic test
- The puncture of the radial artery was made for the instant arterial blood gaz as well as for venous biochemistry
- The one-drop finger pulp blood test was made for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum
| Study group | Role | What they receive |
|---|---|---|
| PEDCUK_0000 | Children aged 2 to 9 years, admitted to the paediatric intensive care units for severe malaria Receives: Diagnostic Test: Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7
Secondary outcomes (1)
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.
Measured: From day 1 of admission to the PICU until death or recovery (discharge from hospital), assessed up to day 7 post-admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start30 Jan 2017
- Primary completion1 Feb 2017
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Kinshasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Bisabu, Kelu, University of Kinshasa
- Investigators
- Celestin Ndosimao Nsibu, Full professor, Study director, Kinshasa UniversityJoseph Mabiala Bodi, Full professor, Study chair, Kinshasa UniversityLeon Tshilolo, Full professor, Study chair, Kinshasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355426
- Sponsor's protocol ID
- SM_PEDCUK
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berkley JA, Ross A, Mwangi I, Osier FH, Mohammed M, Shebbe M, Lowe BS, Marsh K, Newton CR. Prognostic indicators of early and late death in children admitted to district hospital in Kenya: cohort study. BMJ. 2003 Feb 15;326(7385):361. doi: 10.1136/bmj.326.7385.361.
PubMed 12586667Kumar N, Thomas N, Singhal D, Puliyel JM, Sreenivas V. Triage score for severity of illness. Indian Pediatr. 2003 Mar;40(3):204-10.
PubMed 12657751Helbok R, Kendjo E, Issifou S, Lackner P, Newton CR, Kombila M, Agbenyega T, Bojang K, Dietz K, Schmutzhard E, Kremsner PG. The Lambarene Organ Dysfunction Score (LODS) is a simple clinical predictor of fatal malaria in African children. J Infect Dis. 2009 Dec 15;200(12):1834-41. doi: 10.1086/648409.
PubMed 19911989Njim T, Tanyitiku BS. Prognostic models for the clinical management of malaria and its complications: a systematic review. BMJ Open. 2019 Nov 26;9(11):e030793. doi: 10.1136/bmjopen-2019-030793.
PubMed 31772089World malaria report 2024. Geneva: World Health Organization. 2024
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric In-Hospital Mortality Risk in Congolese Children With Severe Malaria: Derivation of Clinical Prediction Models Using Machine Learning Based-Algorithms
- ClinicalTrials.gov ID
- NCT07355426
- Acronym / sponsor ID
- SM_PEDCUK
- Conditions
- Severe Malaria
- Keywords
- Severe malaria, Paediatric in-hospital mortality risk, Machine learning-based algorithms, Predictive model, Plasmodium falciparum, Multiple Organ Dysfunction Syndrome (MODS), Metabolic acidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of KinshasaUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- An arterial blood sample of 3 ml by puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry, including albumin, phosphate, chlorine, magnesium, urea, creatinine and total bilirubin dosages, and,
- A one-drop finger pulp blood test for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum.
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).
Detailed description
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:
- The prevalence of Multiple Organ Dysfunction Syndrome (MODS) and metabolic acidosis in children presenting with severe malaria will be determined.
- 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:
- The degree of severity of MODS and metabolic acidosis.
- The length of stay for severe malaria in the PICU
- The risk of death following hospitalization for severe malaria
- The influence of parasitemia on disease severity
- The performance of the proposed novel model will be measured
- The predictive nomogram and scoring system will be associated with it.
- Investigators validate and compare the performance of existing models for predicting severe malaria severity against the proposed novel model.
Together, research data will provide proof of principle supporting early interventions and treatment choices in children presenting with severe malaria.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEDCUK_0000 | – | Diagnostic Test: Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistryChildren aged 2 to 9 years, admitted to the paediatric intensive care units for severe malaria |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry1. 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 | Diagnostic test | PEDCUK_0000 |
Primary outcome
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]
Time frame: Day 7
Death was defined as a categorical variable, defining patients who died and those who survived.
1 secondary outcome
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]
Time frame: From day 1 of admission to the PICU until death or recovery (discharge from hospital), assessed up to day 7 post-admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 12586667Berkley JA, Ross A, Mwangi I, Osier FH, Mohammed M, Shebbe M, Lowe BS, Marsh K, Newton CR. Prognostic indicators of early and late death in children admitted to district hospital in Kenya: cohort study. BMJ. 2003 Feb 15;326(7385):361. doi: 10.1136/bmj.326.7385.361.
- Background: PubMed 12657751Kumar N, Thomas N, Singhal D, Puliyel JM, Sreenivas V. Triage score for severity of illness. Indian Pediatr. 2003 Mar;40(3):204-10.
- Background: PubMed 19911989Helbok R, Kendjo E, Issifou S, Lackner P, Newton CR, Kombila M, Agbenyega T, Bojang K, Dietz K, Schmutzhard E, Kremsner PG. The Lambarene Organ Dysfunction Score (LODS) is a simple clinical predictor of fatal malaria in African children. J Infect Dis. 2009 Dec 15;200(12):1834-41. doi: 10.1086/648409.
- Background: PubMed 31772089Njim T, Tanyitiku BS. Prognostic models for the clinical management of malaria and its complications: a systematic review. BMJ Open. 2019 Nov 26;9(11):e030793. doi: 10.1136/bmjopen-2019-030793.
- BackgroundWorld malaria report 2024. Geneva: World Health Organization. 2024
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celestin Ndosimao Nsibu, Full professor study director
Kinshasa University
Joseph Mabiala Bodi, Full professor study chair
Kinshasa University
Leon Tshilolo, Full professor study chair
Kinshasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Malaria, run by University of Kinshasa at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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] (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07355426, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.