A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings.
Background Plague is a zoonotic disease that, despite affecting humans for more than 5000 years, has historically been the subject of limited drug development activity. Drugs that are currently recommended in treatment guidelines have been approved based on animal studies alone-no pivotal clinical t...
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ftdoajarticles:oai:doaj.org/article:d1dc539a3b634e0d9f1021cae071cb65 2024-09-09T19:27:52+00:00 A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. Josephine Bourner Lovarivelo Andriamarohasina Alex Salam Nzelle Delphine Kayem Rindra Randremanana Piero Olliaro 2023-11-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0011509 https://doaj.org/article/d1dc539a3b634e0d9f1021cae071cb65 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0011509 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0011509 https://doaj.org/article/d1dc539a3b634e0d9f1021cae071cb65 PLoS Neglected Tropical Diseases, Vol 17, Iss 11, p e0011509 (2023) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2023 ftdoajarticles https://doi.org/10.1371/journal.pntd.0011509 2024-08-05T17:50:02Z Background Plague is a zoonotic disease that, despite affecting humans for more than 5000 years, has historically been the subject of limited drug development activity. Drugs that are currently recommended in treatment guidelines have been approved based on animal studies alone-no pivotal clinical trials in humans have yet been completed. As a result of the sparse clinical research attention received, there are a number of methodological challenges that need to be addressed in order to facilitate the collection of clinical trial data that can meaningfully inform clinicians and policy-makers. One such challenge is the identification of clinically-relevant endpoints, which are informed by understanding the clinical characterisation of the disease-how it presents and evolves over time, and important patient outcomes, and how these can be modified by treatment. Methodology/principal findings This systematic review aims to summarise the clinical profile of 1343 patients with bubonic plague described in 87 publications, identified by searching bibliographic databases for studies that meet pre-defined eligibility criteria. The majority of studies were individual case reports. A diverse group of signs and symptoms were reported at baseline and post-baseline timepoints-the most common of which was presence of a bubo, for which limited descriptive and longitudinal information was available. Death occurred in 15% of patients; although this varied from an average 10% in high-income countries to an average 17% in low- and middle-income countries. The median time to death was 1 day, ranging from 0 to 16 days. Conclusions/significance This systematic review elucidates the restrictions that limited disease characterisation places on clinical trials for infectious diseases such as plague, which not only impacts the definition of trial endpoints but has the knock-on effect of challenging the interpretation of a trial's results. For this reason and despite interventional trials for plague having taken place, questions around ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 17 11 e0011509 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Josephine Bourner Lovarivelo Andriamarohasina Alex Salam Nzelle Delphine Kayem Rindra Randremanana Piero Olliaro A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Background Plague is a zoonotic disease that, despite affecting humans for more than 5000 years, has historically been the subject of limited drug development activity. Drugs that are currently recommended in treatment guidelines have been approved based on animal studies alone-no pivotal clinical trials in humans have yet been completed. As a result of the sparse clinical research attention received, there are a number of methodological challenges that need to be addressed in order to facilitate the collection of clinical trial data that can meaningfully inform clinicians and policy-makers. One such challenge is the identification of clinically-relevant endpoints, which are informed by understanding the clinical characterisation of the disease-how it presents and evolves over time, and important patient outcomes, and how these can be modified by treatment. Methodology/principal findings This systematic review aims to summarise the clinical profile of 1343 patients with bubonic plague described in 87 publications, identified by searching bibliographic databases for studies that meet pre-defined eligibility criteria. The majority of studies were individual case reports. A diverse group of signs and symptoms were reported at baseline and post-baseline timepoints-the most common of which was presence of a bubo, for which limited descriptive and longitudinal information was available. Death occurred in 15% of patients; although this varied from an average 10% in high-income countries to an average 17% in low- and middle-income countries. The median time to death was 1 day, ranging from 0 to 16 days. Conclusions/significance This systematic review elucidates the restrictions that limited disease characterisation places on clinical trials for infectious diseases such as plague, which not only impacts the definition of trial endpoints but has the knock-on effect of challenging the interpretation of a trial's results. For this reason and despite interventional trials for plague having taken place, questions around ... |
format |
Article in Journal/Newspaper |
author |
Josephine Bourner Lovarivelo Andriamarohasina Alex Salam Nzelle Delphine Kayem Rindra Randremanana Piero Olliaro |
author_facet |
Josephine Bourner Lovarivelo Andriamarohasina Alex Salam Nzelle Delphine Kayem Rindra Randremanana Piero Olliaro |
author_sort |
Josephine Bourner |
title |
A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
title_short |
A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
title_full |
A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
title_fullStr |
A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
title_full_unstemmed |
A systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
title_sort |
systematic review of the clinical profile of patients with bubonic plague and the outcome measures used in research settings. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2023 |
url |
https://doi.org/10.1371/journal.pntd.0011509 https://doaj.org/article/d1dc539a3b634e0d9f1021cae071cb65 |
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Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 17, Iss 11, p e0011509 (2023) |
op_relation |
https://doi.org/10.1371/journal.pntd.0011509 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0011509 https://doaj.org/article/d1dc539a3b634e0d9f1021cae071cb65 |
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https://doi.org/10.1371/journal.pntd.0011509 |
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PLOS Neglected Tropical Diseases |
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17 |
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11 |
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e0011509 |
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