Development and Evaluation of an Electronic Algorithm Using a Combination of a Two-step Malaria RDT, and Other Rapid Diagnostic Tools for the Management of Febrile Illness in Children Under 5 Attending Outpatient Facilities in Burkina Faso.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,176
- Locations
- 2
- Primary Endpoint
- Determine the rate acute febrile cases with favorable outcome at Day 7 visit
Study Overview
Brief Summary
In Sub-Saharan Africa (SSA), fever remains a major public health problem in children. The introduction of malaria rapid diagnostic tests (RDTs) in routine healthcare has greatly improved the management of malaria. However, despite the good attitude of healthcare workers to adhere to malaria RDT test results, persisting hrp2antigen and low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescriptions practices. This is one of the main causes of antimicrobial resistance (AMR) and inappropriate management of febrile diseases. To improve the diagnosis of febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH supported by point-of-care tests (POCTs) for C-reactive protein, oximetry, and bacterial infection such as Group A Streptococcus, and Salmonella/Shigella, will significantly improve the management of febrile diseases and thereby tackling AMR.
To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children under 5 years is proposed.
- In the control arm, febrile children will benefit from a complete clinical examination. Treatment will be done according to the national guideline.
- In RDTs decisional algorithm (RDT-DA) arm (intervention), the complete clinical examination will be supported by two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers.
- In e-algorithm arm (intervention), the complete clinical examination and the outcomes of RDTs (malaria and bacterial infections) will be digitalized. Diagnostic and prescription will be done by the algorithm.
A final follow-up visit (day7) will be scheduled for all participants. Patients will be asked to return to the health facilities in case of no improvement.
Primary study outcomes will be the proportion of curative case and antimicrobial(s) prescribed in each arm. Secondary outcomes include: (i) adherence of healthcare workers to the algorithm; (ii) adherence of parents/guardian to treatment; (iii) accuracy of the algorithm for the diagnostic of malaria.
This project will serve as a path of policy change in the management of febrile diseases and AMR. By relying on existing RDTs available, the implementation of this algorithm will tackle AMR and provide better care. If successful, the project will equip the lead applicant to establish himself as an independent researcher with ability to further build his own research team. The project will also offer training opportunities to young scientists, and further strengthen already existing capacities of the home institute.
Detailed Description
Background In Sub-Saharan Africa (SSA), febrile illnesses remains a major public health problem in children. The introduction of malaria rapid diagnostic tests (RDTs) in routine healthcare has greatly improved the management of malaria. However, despite the good attitude of healthcare workers to adhere to malaria RDT test results, persisting hrp2 antigen and low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescriptions practices. These limitations of the RDTs lead to poor management of febrile diseases and antimicrobial resistance (AMR). To improve the diagnosis of these febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH supported by point-of-care tests (POCTs) for C-reactive protein, white blood cells (WBC) count, urine dipstick, oximetry, and bacterial infection such as Group A Streptococcus, and Salmonella/Shigella, will significantly improve the management of febrile diseases and thereby tackling AMR.
Methodology To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children from 2 to 59 months is proposed.
- In the control arm, febrile children will be managed according to the IMCI (integrative management of childhood illnesses) and the guideline of diagnostic and treatment (GDT), which are part of the routine system existing in Burkina Faso. Treatment will be done according to the national guideline.
- In RDTs decisional algorithm (RDT-DA) arm (intervention), the clinical examination based on IMIC will be supported by two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers.
- In e-algorithm arm (intervention), artificial intelligence integrating multiple layers of clinical information such as clinical examination, signs/symptoms and medical history, and laboratory information such as outcomes of biomarkers (CRP and WBC) and pathogen specific POCT (malaria and bacterial infections) and oximetry will be developed. The e-algorithm will serve to guide the diagnostic and management of febrile infections in children from 2 to 59 months.
In the 3 arms, the supports of data collection will be digitalized. A final follow-up visit (day7) will be scheduled for all participants. Patients will be asked to come back to the health facilities before scheduled visit if the symptoms persist or health condition worsening.
Study Duration This is estimated to be 36 months from the start of the study. The first 12 months will be reserved for the development of the algorithm (artificial intelligence) of e-Algorithm arm and the study CRFs for RDT-DA and control arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 2 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children from 2 to 59 months of age;
- •Acute fever (axillary temperature over or equal to 37.5°) or history of fever within the past 7 days;
- •Available to return for the follow-up visit at the health facility on day 7 (±2).
- •Written informed consent obtained from parents/legal guardian.
Exclusion Criteria
- •Children less than 2 months or over 59 months;
- •Presence of signs and symptoms of severe infections;
- •Children with chronic febrile infections.
Arms & Interventions
Control Arm
Febrile children will be managed according to the IMCI (integrative management of childhood illnesses) and the guideline of diagnostic and treatment (GDT), which are part of the routine system existing in Burkina Faso. Treatment will be done according to the national guideline.
RDTs decisional Arm
The clinical examination based on IMIC will be supported by two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers.
Intervention: Two-step malaria RDT detecting PfHRP2/pLDH (SD Ag Bioline Malaria Ag P.f/Pan: Standard Diagnostics, Hagal-Dong, Korea) (Diagnostic Test)
e-algorithm Arm
Artificial intelligence integrating multiple layers of clinical information such as clinical examination, signs/symptoms and medical history, and laboratory information such as outcomes of biomarkers (CRP and WBC) and pathogen specific POCT (malaria and bacterial infections) and oximetry will be developed. The e-algorithm will serve to guide the diagnostic and management of febrile infections in children from 2 to 59 months.
Intervention: Two-step malaria RDT detecting PfHRP2/pLDH (SD Ag Bioline Malaria Ag P.f/Pan: Standard Diagnostics, Hagal-Dong, Korea) (Diagnostic Test)
Outcomes
Primary Outcomes
Determine the rate acute febrile cases with favorable outcome at Day 7 visit
Time Frame: 7 days follow-up
Favorable outcome is defined as being alive and absence of symptoms
Determine the proportion of antibiotic and antimalarial prescriptions in acute febrile cases.
Time Frame: 7 days follow-up
Proportion of antibiotic prescription for acute febrile cases at the health facility.
Secondary Outcomes
- Determine the proportion of participants who adhered to antimalarial and antibiotic prescription(7 days follow-up)
- Determine the accuracy of the algorithm for the diagnostic of malaria(Enrollment (Day 0))