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Prediction of Disease Severity in Young Children Presenting With Acute Febrile Illness in Resource-limited Settings (SPOT-SEPSIS)

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ClinicalTrials.gov Identifier: NCT04285021
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit
Gadjah Mada University
Laos-Oxford-Mahosot Wellcome Trust Research Unit
Cambodia Oxford Medical Research Unit
Ho Chi Minh City University of Medicine and Pharmacy
Research Institute for Tropical Medicine, Philippines
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Medecins Sans Frontieres, Spain

Brief Summary:

Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford.

The primary objective is to develop a risk prediction algorithm, combining measurements of host biomarkers and clinical features at the point-of-triage, for children with an acute febrile illness in resource-limited settings.

The secondary objectives are to determine which host biomarkers, feasible for measurement at the point-of-care, are predictive of disease severity. Additionally to determine the optimal combination of clinical features (including demographics, anthropometric data, historical variables, vital signs, clinical signs and clinical symptoms), feasible for assessment by limited-skill health workers, that is predictive of disease severity.

The tertiary objectives are to explore the impact of different methods of outcome classification on development of the risk prediction algorithm, and to explore the performance of the algorithm to predict disease severity in key presenting clinical syndromes and aetiologies.


Condition or disease
Sepsis

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Disease Severity in Young Children Presenting With Acute Febrile Illness in Resource-limited Settings
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Sepsis




Primary Outcome Measures :
  1. Risk prediction algorithm [ Time Frame: 12-15 months ]
    To predict disease severity for children with an acute febrile illness in resource-limited settings by combining measurements of host biomarkers and clinical features at the point-of-triage


Secondary Outcome Measures :
  1. Biomarkers [ Time Frame: 12-15 months ]
    Determine which host biomarkers, feasible for measurement at the point-of-care, are predictive of disease severity

  2. Clinical features of severity [ Time Frame: 12-15 months ]
    Determine the optimal combination of clinical features (including demographics, anthropometric data, historical variables, vital signs, clinical signs and clinical symptoms), feasible for assessment by limited-skill health workers, that is predictive of disease severity


Other Outcome Measures:
  1. Outcome classification for severity [ Time Frame: 12-15 months ]
    Explore the impact of different methods of outcome classification on development of the risk prediction algorithm

  2. Risk prediction algorithm performance [ Time Frame: 12-15 months ]
    Explore the performance of the algorithm to predict disease severity in key presenting clinical syndromes and aetiologies


Biospecimen Retention:   Samples With DNA
Blood will be taken for biomarker assessment from all children, which may include pathogenic identification.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged > 28 days and < 5 years presenting to the study site with an acute febrile illness
Criteria

Inclusion Criteria

The participant may enter the study if ALL of the following apply:

  1. Caretaker is willing and able to give informed consent for participation in the study;
  2. Aged > 28 days and < 5 years [day of birth = Day 1];
  3. Axillary temperature at presentation ≥ 37.5°C OR axillary temperature at presentation < 35.5°C OR history of fever in last 24h;
  4. Onset of illness ≤ two weeks.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

  1. Accident or trauma is the cause for child's presentation;
  2. Presentation ≤ 72 hours after routine immunisations;
  3. Known chronic medical condition including immunosuppression (for example, oncological conditions, HIV infection, thalassaemia, current steroid use), active chronic infection (for example, tuberculosis, hepatitis B virus), active cardiorespiratory conditions (for example, symptomatic or currently medicated congenital heart disease, cardiomyopathy or bronchiectasis);
  4. Admission to any health facility during the current illness;
  5. Previously enrolled in the study for a different acute illness;
  6. Receipt of > 15 minutes of inpatient treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285021


Contacts
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Contact: Mikhael Yosia, MD +6281378778784 msfe-jakarta-med@barcelona.msf.org
Contact: Arjun Chandna, MD +85585712586 arjun@tropmedres.ac

Locations
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Bangladesh
MSF Goyalmara Green Roof Hospital Recruiting
Cox's Bāzār, Bangladesh
Contact: Dinesh Mondal, PhD    +8801712027091    din63d@icddrb.org   
Contact: Mohammad Shomik, MD    +8801714132715    mshomik@icddrb.org   
Cambodia
Angkor Hospital for Children Recruiting
Siem Reap, Krong Siem Reap, Cambodia
Contact: Paul Turner, PhD       pault@tropmedres.ac   
Contact: Arjun Chandna, MD    +85585712586    arjun@tropmedres.ac   
Indonesia
Rumah Sakit Umum Daerah Wates Recruiting
Yogyakarta, DI Yogyakarta, Indonesia
Contact: Eggi Argunni, MD    +6281578531122    eggiarguni@ugm.ac.id   
Contact: Riris Ahmad, PhD       risandono_ahmad@ugm.ac.id   
Lao People's Democratic Republic
Laos-Oxford-Mahosot Wellcome Trust Research Unit Recruiting
Vientiane, Lao People's Democratic Republic
Contact: Elizabeth Ashley, MD       liz@tropmedres.ac   
Contact: Mayfong Mayxay, MD       mayfong@tropmedres.ac   
Philippines
Research Institute Tropical Medicine Not yet recruiting
Manila, Philippines
Contact: Veronica Tallo, PhD    +639177988553    vickee.popmetrics@gmail.com   
Contact: Nicole Perraras    +639175001092    nicoleperreras@yahoo.com   
Vietnam
Dong Nai Children's Hospital Not yet recruiting
Đông Nãi, Vietnam
Contact: Phung Nguyen The Nguyen, PhD       nguyenphung@ump.edu.vn   
Contact: Bui Thanh Liem, MD       liem.bui@ump.edu.vn   
Sponsors and Collaborators
Medecins Sans Frontieres, Spain
Mahidol Oxford Tropical Medicine Research Unit
Gadjah Mada University
Laos-Oxford-Mahosot Wellcome Trust Research Unit
Cambodia Oxford Medical Research Unit
Ho Chi Minh City University of Medicine and Pharmacy
Research Institute for Tropical Medicine, Philippines
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Sakib Burza, PhD Medecins Sans Frontieres, Spain
Principal Investigator: Yoel Lubell, PhD Mahidol Oxford Tropical Medicine Research Unit
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medecins Sans Frontieres, Spain
ClinicalTrials.gov Identifier: NCT04285021    
Other Study ID Numbers: HCR18004
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medecins Sans Frontieres, Spain:
Febrile illness
Biomarker
Clinical Severity Scale
Disease severity
Resource-limited setting
Additional relevant MeSH terms:
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Fever
Body Temperature Changes