Clinical trial NCT02225769: Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children
Official title: Electronic Algorithms Based on Host Biomarkers Point of Care Tests to Decide on Admission and Antibiotic Prescription in Tanzanian Febrile Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Febrile Illness
Keywords: fever
point-of-care tests
clinical algorithms
electronic support
host biomarkers
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-08-26
Enrollment: 3192
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of clinical failure by day 7 compared among the 3 study arms.
timeFrame: 10 months
Secondary outcomes:
measure: Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms.
timeFrame: 10 months
measure: Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms.
timeFrame: 10 months
measure: Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm)
timeFrame: 10 months
measure: Proportion of primarily admitted children compared among the 3 study arms.
timeFrame: 10 months
Other outcomes:
measure: 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).
timeFrame: 22 months
Locations:
city: Dar es Salaam
country: Tanzania
facility: Rangi tatu, Magomeni and Tandale health centers
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Valérie D'Acremont, MD, PhD, MiH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laubscher F, Hartley MA, Kaiser L, Cordey S. Genomic Diversity of Torque Teno Virus in Blood Samples from Febrile Paediatric Outpatients in Tanzania: A Descriptive Cohort Study. Viruses. 2022 Jul 23;14(8):1612. doi: 10.3390/v14081612.
citation: Cordey S, Laubscher F, Hartley MA, Junier T, Keitel K, Docquier M, Guex N, Iseli C, Vieille G, Le Mercier P, Gleizes A, Samaka J, Mlaganile T, Kagoro F, Masimba J, Said Z, Temba H, Elbanna GH, Tapparel C, Zanella MC, Xenarios I, Fellay J, D'Acremont V, Kaiser L. Blood virosphere in febrile Tanzanian children. Emerg Microbes Infect. 2021 Dec;10(1):982-993. doi: 10.1080/22221751.2021.1925161.
citation: Keitel K, Samaka J, Masimba J, Temba H, Said Z, Kagoro F, Mlaganile T, Sangu W, Genton B, D'Acremont V. Safety and Efficacy of C-reactive Protein-guided Antibiotic Use to Treat Acute Respiratory Infections in Tanzanian Children: A Planned Subgroup Analysis of a Randomized Controlled Noninferiority Trial Evaluating a Novel Electronic Clinical Decision Algorithm (ePOCT). Clin Infect Dis. 2019 Nov 13;69(11):1926-1934. doi: 10.1093/cid/ciz080.
citation: Keitel K, Kagoro F, Samaka J, Masimba J, Said Z, Temba H, Mlaganile T, Sangu W, Rambaud-Althaus C, Gervaix A, Genton B, D'Acremont V. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT): A randomized, controlled non-inferiority trial. PLoS Med. 2017 Oct 23;14(10):e1002411. doi: 10.1371/journal.pmed.1002411. eCollection 2017 Oct.