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Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children (e-POCT)

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ClinicalTrials.gov Identifier: NCT02225769
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Valérie D'Acremont, Swiss Tropical & Public Health Institute

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.

Condition or disease Intervention/treatment Phase
Acute Febrile Illness Other: Management of febrile children using e-POCT Other: Management of febrile children using ALMANACH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Electronic Algorithms Based on Host Biomarkers Point of Care Tests to Decide on Admission and Antibiotic Prescription in Tanzanian Febrile Children
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: e-POCT
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
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).

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

No Intervention: Routine practice
Febrile children managed according to routine care such as provided by routine health facility health workers.



Primary Outcome Measures :
  1. Proportion of clinical failure by day 7 compared among the 3 study arms. [ Time Frame: 10 months ]
    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).


Secondary Outcome Measures :
  1. Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms. [ Time Frame: 10 months ]
    This 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.

  2. Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms. [ Time Frame: 10 months ]
    This outcome is used to compare the rational use of antimicrobials in treating febrile children using e-POCT, ALMANACH and routine care.

  3. Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm) [ Time Frame: 10 months ]
    The aim is to measure the proportion of febrile children with hypoxemia, stratified by diagnostic classification (e-POCT arm only).

  4. Proportion of primarily admitted children compared among the 3 study arms. [ Time Frame: 10 months ]
    The 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 Outcome Measures:
  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). [ Time Frame: 22 months ]
    The 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02225769


Locations
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Tanzania
Rangi tatu, Magomeni and Tandale health centers
Dar es Salaam, Tanzania
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Swiss National Science Foundation
Investigators
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Principal Investigator: Valérie D'Acremont, MD, PhD, MiH Swiss Tropical & Public Health Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Valérie D'Acremont, Group leader, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT02225769     History of Changes
Other Study ID Numbers: IZ01Z0_146896
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by Valérie D'Acremont, Swiss Tropical & Public Health Institute:
fever
point-of-care tests
clinical algorithms
electronic support
host biomarkers
Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms