Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children

Acute Febrile Illness Clinical Trial

— e-POCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225769
• Other study ID #: IZ01Z0_146896
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: October 11, 2016
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3192
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Febrile Illness
• Fever

Intervention

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).
• 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

Locations

Country	Name	City	State
Tanzania	Rangi tatu, Magomeni and Tandale health centers	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Swiss National Science Foundation

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	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).	22 months	No
Primary	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	Yes
Secondary	Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms.	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.	10 months	Yes
Secondary	Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms.	This outcome is used to compare the rational use of antimicrobials in treating febrile children using e-POCT, ALMANACH and routine care.	10 months	No
Secondary	Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm)	The aim is to measure the proportion of febrile children with hypoxemia, stratified by diagnostic classification (e-POCT arm only).	10 months	No
Secondary	Proportion of primarily admitted children compared among the 3 study arms.	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.	10 months	Yes