Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children

NCT02225769 | Completed DMC

• 1 other identifier: IZ01Z0_146896
• Study Type: interventional
• Target: 3,192
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Febrile Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of clinical failure by day 7 compared among the 3 study arms.

  This 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).

  10 months

Secondary Outcomes (4)

• Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms.

  10 months

• Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms.

  10 months

• Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm)

  10 months

• Proportion of primarily admitted children compared among the 3 study arms.

  10 months

Other Outcomes (1)

• 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 months

Study Arms (3)

e-POCT

EXPERIMENTAL

Febrile children managed using the e-POCT tool. 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).

Other: Management of febrile children using e-POCT

ALMANACH

ACTIVE COMPARATOR

Febrile children managed using the ALMANACH algorithm. ALMANACH is an improved Integrated Management of childhood Illness (IMCI) algorithm based on mobile phones and tablets that has already been assessed for safety and efficacy.

Other: Management of febrile children using ALMANACH

Routine practice

NO INTERVENTION

Febrile children managed according to routine care such as provided by routine health facility health workers.

Interventions

Management of febrile children using e-POCT OTHER

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).

e-POCT

Management of febrile children using ALMANACH OTHER

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

ALMANACH

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Rangi tatu, Magomeni and Tandale health centers

Dar es Salaam, Dar es Salaam Region, Tanzania

Location

Related Publications (4)

• 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.

  PMID: 35893678 DERIVED

• 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.

  PMID: 33929935 DERIVED

• 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.

  PMID: 30715250 DERIVED

• 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.

  PMID: 29059253 DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie D'Acremont, MD, PhD, MiH

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

TA (1)