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Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children

Electronic Algorithms Based on Host Biomarkers Point of Care Tests to Decide on Admission and Antibiotic Prescription in Tanzanian Febrile Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02225769
Acronym
e-POCT
Enrollment
3192
Registered
2014-08-26
Start date
2014-12-31
Completion date
2016-02-29
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Febrile Illness

Keywords

fever, point-of-care tests, clinical algorithms, electronic support, host biomarkers

Brief summary

Health professionals in developing countries have limited ability to identify children at risk of dying and those in need of antibiotics. The main reasons are limited clinical skills and time, unavailability of diagnostic tests (laboratory or x-ray) and non-adherence to practice guidelines. Child mortality is therefore higher than it should be. Etiological diagnostic tests (detecting microorganisms) may not always help since the distinction between infection and disease and between mild or severe disease is not straightforward. Overprescription of antibiotics is therefore widespread and leads to the development of drug resistance. To address these challenges, decision charts for the management of febrile illness will be developed and include i) few clinical parameters simple to assess, and ii) POCTs results based on specific host markers that can discriminate between mild and severe disease, pneumonia and upper respiratory tract infections, and unspecific fevers of bacterial and of viral origin. This algorithm combining clinical and bedside laboratory tests will be built on an electronic support (android tablet). The first objective of the study is to assess the safety of new electronic decision trees that integrate simple clinical assessment and POCTs results (oxygen saturation and a combination of specific biomarkers of inflammation) as a triage tool to decide on admitting febrile children; the second objective is to assess the usefulness and safety of new electronic decision trees that integrate simple clinical assessment and POCT results (a combination of specific biomarkers of inflammation) as decision-making tool to prescribe antibiotics to non-severe febrile children. The development of such a tool will decrease mortality due to delayed admission, At the same time, it will decrease irrational use of antibiotics, and hence drug pressure and emergence of drug resistance, which represents one of the most important public health threat our world is facing today. This project has the potential of huge applicability since it is specifically designed for end-users with limited medical skills and low resources, as it is the case in most areas of developing countries.

Interventions

OTHERManagement of febrile children using e-POCT

Use of the e-POCT tool by study clinicians for the clinical management of febrile episodes. The e-POCT tool is an electronic algorithm that integrates key clinical elements with the results of malaria and host biomarkers point-of-care test results (including oximetry).

OTHERManagement of febrile children using ALMANACH

Management of febrile children by study clinicians using ALMANACH. ALMANACH is an improved IMCI algorithm on mobile phone or tablet

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
Swiss Tropical & Public Health Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 59 Months
Healthy volunteers
No

Inclusion criteria

* Age ≥2 months and \<60 months of age * Written informed consent from the child's parent or caregiver * Axillary temperature ≥37.5°C and/or tympanic temperature ≥38.0°C * History of fever for ≤7 days * First consultation for the current illness * Live in the catchment area of the health facility

Exclusion criteria

* Age 60 months or greater * Age less than 2 months * Weight less than 2.5kg * Chief health problem is an injury, trauma or acute poisoning

Design outcomes

Primary

MeasureTime frameDescription
Proportion of clinical failure by day 7 compared among the 3 study arms.10 monthsThis outcome measure is used to compare the clinical outcome of febrile children 2-59 months of age managed using e-POCT (intervention arm), ALMANACH (reference control arm) and routine practice (routine control arm).

Secondary

MeasureTime frameDescription
Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms.10 monthsThis outcome measure is also used to compare the clinical outcome of febrile children 2-59 months of age managed using e-POCT (intervention arm), ALMANACH (reference control arm) and routine practice (routine control arm). This type of event is however too rare to be used as primary endpoint.
Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms.10 monthsThis outcome is used to compare the rational use of antimicrobials in treating febrile children using e-POCT, ALMANACH and routine care.
Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm)10 monthsThe aim is to measure the proportion of febrile children with hypoxemia, stratified by diagnostic classification (e-POCT arm only).
Proportion of primarily admitted children compared among the 3 study arms.10 monthsThe objective is to compare the performance of e-POCT, ALMANACH and routine care in identifying children at risk for life-threatening infection among febrile children.

Other

MeasureTime frameDescription
Diagnostic performance of combinations of host biomarkers in identifying children at risk for life-threatening infections and for clinical failure among children presenting with fever (e-POCT and ALMANACH arms).22 monthsThe objective is to explore the performance of combinations of host biomarkers in identifying children in need for antibiotic treatment, by type of infection (ALMANACH arm).

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026