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
Abstract Background In Sub-Saharan Africa (SSA), febrile illnesses remain a major public health problem in children. However, the persistence of hrp2 antigen and the low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescription practices. These limitations lead to poor man...
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06717-8 |
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| author | Francois Kiemde Adelaide Compaore Fla Koueta Athanase M. Some Berenger Kabore Daniel Valia Toussaint Rouamba Fadima Yaya Bocoum Seydou Sawadogo Macaire Nana Diane Y. Some Nadine A. Kone Valentin Pagbeleguem Inoussa Sangare Antonia W. Bere Massa dit Achille Bonko Gautier Tougri Sylvie Yeri Youl Henk Schallig Halidou Tinto |
| author_facet | Francois Kiemde Adelaide Compaore Fla Koueta Athanase M. Some Berenger Kabore Daniel Valia Toussaint Rouamba Fadima Yaya Bocoum Seydou Sawadogo Macaire Nana Diane Y. Some Nadine A. Kone Valentin Pagbeleguem Inoussa Sangare Antonia W. Bere Massa dit Achille Bonko Gautier Tougri Sylvie Yeri Youl Henk Schallig Halidou Tinto |
| author_sort | Francois Kiemde |
| collection | DOAJ |
| description | Abstract Background In Sub-Saharan Africa (SSA), febrile illnesses remain a major public health problem in children. However, the persistence of hrp2 antigen and the low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescription practices. These limitations 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 (PoC) tests for bacterial infections could significantly improve the management of febrile diseases and thereby tackling AMR. Methods To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children from 6 to 59 months is proposed. In the control arm, febrile children will be managed according to the Integrated Management of Childhood Illnesses (IMCI), which is part of the standard of care in Burkina Faso. Treatment will be done according to national guidelines. In the RDT decisional algorithm (RDT-DA) arm (intervention), the clinical examination based on IMIC will be supported by a two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers based on clinical examination and PoC test results. In the e-algorithm arm (intervention), artificial intelligence integrating multiple layers of clinical information such as clinical examination, signs/symptoms and medical history, and biological information such as biomarkers (CRP and WBC) and pathogen-specific PoC tests, and oximetry will be developed. The e-algorithm will serve to guide the diagnostic and management of febrile infections in children. In the 3 arms, the case report forms will be digitalized. A final follow-up visit (day 7) will be scheduled for all participants. Patients will be asked to come back to the health facilities before the scheduled visit if the symptoms persist or in case of health condition worsening. Discussion If successful, this study could contribute to improve the management of febrile diseases and reduce inappropriate use of antimicrobials. Trial registration The trial is registered at ClinicalTrial.gov, NCT05285657. Enrolment started on 4 March 2022 with long-term outcome being assessed completely by 2023. |
| first_indexed | 2024-04-14T08:20:24Z |
| format | Article |
| id | doaj.art-c8c0fcbd1e234797b71d75d923c4db63 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-14T08:20:24Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c8c0fcbd1e234797b71d75d923c4db632022-12-22T02:04:14ZengBMCTrials1745-62152022-09-0123111610.1186/s13063-022-06717-8Development 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 FasoFrancois Kiemde0Adelaide Compaore1Fla Koueta2Athanase M. Some3Berenger Kabore4Daniel Valia5Toussaint Rouamba6Fadima Yaya Bocoum7Seydou Sawadogo8Macaire Nana9Diane Y. Some10Nadine A. Kone11Valentin Pagbeleguem12Inoussa Sangare13Antonia W. Bere14Massa dit Achille Bonko15Gautier Tougri16Sylvie Yeri Youl17Henk Schallig18Halidou Tinto19Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Department of Pediatrics – CHU Yalgado OuedraogoInstitut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Health District of Nanoro, Ministry of HealthInstitut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)National Malaria Control Program, Ministry of HealthNational Agency for Primary Healthcare, Ministry of HealthAmsterdam University Medical Centers, Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Amsterdam Institute for Infection and ImmunityInstitut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Abstract Background In Sub-Saharan Africa (SSA), febrile illnesses remain a major public health problem in children. However, the persistence of hrp2 antigen and the low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescription practices. These limitations 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 (PoC) tests for bacterial infections could significantly improve the management of febrile diseases and thereby tackling AMR. Methods To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children from 6 to 59 months is proposed. In the control arm, febrile children will be managed according to the Integrated Management of Childhood Illnesses (IMCI), which is part of the standard of care in Burkina Faso. Treatment will be done according to national guidelines. In the RDT decisional algorithm (RDT-DA) arm (intervention), the clinical examination based on IMIC will be supported by a two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers based on clinical examination and PoC test results. In the e-algorithm arm (intervention), artificial intelligence integrating multiple layers of clinical information such as clinical examination, signs/symptoms and medical history, and biological information such as biomarkers (CRP and WBC) and pathogen-specific PoC tests, and oximetry will be developed. The e-algorithm will serve to guide the diagnostic and management of febrile infections in children. In the 3 arms, the case report forms will be digitalized. A final follow-up visit (day 7) will be scheduled for all participants. Patients will be asked to come back to the health facilities before the scheduled visit if the symptoms persist or in case of health condition worsening. Discussion If successful, this study could contribute to improve the management of febrile diseases and reduce inappropriate use of antimicrobials. Trial registration The trial is registered at ClinicalTrial.gov, NCT05285657. Enrolment started on 4 March 2022 with long-term outcome being assessed completely by 2023.https://doi.org/10.1186/s13063-022-06717-8FeverRapid diagnostic teste-AlgorithmPrescriptionArtificial intelligence |
| spellingShingle | Francois Kiemde Adelaide Compaore Fla Koueta Athanase M. Some Berenger Kabore Daniel Valia Toussaint Rouamba Fadima Yaya Bocoum Seydou Sawadogo Macaire Nana Diane Y. Some Nadine A. Kone Valentin Pagbeleguem Inoussa Sangare Antonia W. Bere Massa dit Achille Bonko Gautier Tougri Sylvie Yeri Youl Henk Schallig Halidou Tinto 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 Trials Fever Rapid diagnostic test e-Algorithm Prescription Artificial intelligence |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Fever Rapid diagnostic test e-Algorithm Prescription Artificial intelligence |
| url | https://doi.org/10.1186/s13063-022-06717-8 |
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