UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061551 |
|---|---|
| Receipt number | R000070366 |
| Scientific Title | Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria: A Prospective Cohort Study Towards Improving Survival Rates |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/13 12:03:19 |
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Basic information
Public title
Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria: A Prospective Cohort Study Towards Improving Survival Rates
Acronym
Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria
Scientific Title
Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria: A Prospective Cohort Study Towards Improving Survival Rates
Scientific Title:Acronym
Elucidating the Association Between First-Line Antimalarial Drug Susceptibility and Patient Outcomes in African Severe Malaria
Region
| Africa |
Condition
Condition
Malaria
Classification by specialty
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Although malaria-related deaths initially declined following the introduction of the highly effective antimalarial drug artemisinin, the trend reversed in 2020 and has since plateaued, resulting in approximately 600,000 deaths annually. The African region, in particular, accounts for 95% of these fatalities. Why, then, do malaria deaths remain so high?
In 2021, the regional spread of kelch13 mutations associated with decreased artemisinin susceptibility and delayed clinical parasite clearance was demonstrated for the first time in Africa, specifically in Northern Uganda (Balikagara et al., 2021). While the association with clinical outcomes remains unclear at present, the applicant hypothesizes that the blunted rapid efficacy of treatment due to kelch13 mutations contributes to the persistently high mortality.
In this study, we will conduct the first prospective cohort study targeting severe cases in Northern Uganda. By comprehensively exploring prognostic factors from multiple perspectives, including parasite genotypes, in vivo and in vitro drug susceptibility, and patient background, we aim to optimize treatment strategies and improve survival rates.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pSOFA score from baseline to Day 3 (Delta pSOFA)
Key secondary outcomes
Changes in PELODS-2 score, PIM3 score, lactate, hemoglobin, total bilirubin, and platelet count (measured pre-treatment, on Day 3 of treatment, and at discharge); mortality rate; rate of dialysis initiation; ICU admission rate; incidence of neurological sequelae; blood transfusion volume; length of hospital stay; length of ICU stay; time to resolution of severe malaria criteria; and medical costs.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 6 months or older, weighing 5 kg or more, who meet the 2025 WHO diagnostic criteria for severe malaria.
Key exclusion criteria
Patients who have received antimalarial treatment within 2 weeks prior to enrollment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Kosuge |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Tropical Medicine and Parasitology
Zip code
1138421
Address
1-2-2 Hongo Bunkyo-ku Tokyo Japan
TEL
03-5802-1043
a.kosuge.xb@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Kosuge |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Tropical Medicine and Parasitology
Zip code
1138421
Address
1-2-2 Hongo Bunkyo-ku Tokyo Japan
TEL
03-5802-1043
Homepage URL
a.kosuge.xb@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gulu University, St. Mary's Hospital Lacor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Lacor Hospital Institutional Research Ethics Committee
Address
P.O. Box 180, Gulu, Uganda
Tel
+256-471-432310
info@lacorhospital.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
St. Mary's Hospital Lacor (Gulu, Uganda)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will observe the clinical course and prognostic outcomes of eligible subjects presenting at St. Mary's Hospital Lacor in Northern Uganda. To assess drug resistance, capillary blood samples will be collected via finger-prick every 6 hours following the initiation of treatment to prepare blood smears and calculate parasitemia.
Furthermore, to quantify the clinical condition and elucidate its association with drug resistance, blood tests will be conducted at presentation (baseline), and at 24 and 72 hours post-treatment. Physical examinations and ultrasound assessments will also be performed every 24 hours up to 72 hours post-treatment. Subsequently, we will continue to monitor the clinical course until discharge based on medical records.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070366
