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Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials

BACKGROUND: Acinetobacter infections, especially multidrug-resistant (MDR) Acinetobacter infections, are a global health problem. This study aimed to describe clinical outcomes in patients with confirmed Acinetobacter spp. isolates who were treated with tigecycline in randomized clinical trials. MAT...

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Autores principales: Tucker, Hal, Wible, Michele, Gandhi, Ashesh, Quintana, Alvaro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5679678/
https://www.ncbi.nlm.nih.gov/pubmed/29138583
http://dx.doi.org/10.2147/IDR.S143306
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author Tucker, Hal
Wible, Michele
Gandhi, Ashesh
Quintana, Alvaro
author_facet Tucker, Hal
Wible, Michele
Gandhi, Ashesh
Quintana, Alvaro
author_sort Tucker, Hal
collection PubMed
description BACKGROUND: Acinetobacter infections, especially multidrug-resistant (MDR) Acinetobacter infections, are a global health problem. This study aimed to describe clinical outcomes in patients with confirmed Acinetobacter spp. isolates who were treated with tigecycline in randomized clinical trials. MATERIALS AND METHODS: Data from 14 multinational, randomized (open-label or double-blind), and active-controlled (except one) Phase III and IV studies were analyzed using descriptive statistics. RESULTS: A total of 174 microbiologically evaluable patients with Acinetobacter spp. infections (including MDR infections) were identified, and 95 received tigecycline to treat community-acquired pneumonia (CAP), diabetic foot infections (DFIs), hospital-acquired pneumonia (HAP), complicated intra-abdominal infections (cIAIs), infections with resistant pathogens (RPs), or complicated skin and skin-structure infections. The rate of cure of tigecycline for most indications was 70%–80%, with the highest (88.2%) in cIAIs. The rate of cure of the comparators was generally higher than tigecycline, but within each indication the 95% CIs for clinical cure for each treatment group overlapped. For most Acinetobacter isolates, the minimum inhibitory concentration of tigecycline was 0.12–2 μg/mL, with seven at 4 μg/mL and one at 8 μg/mL. The cure rate by tigecycline was 50% (95% CI 12.5%–87.5% in CAP) to 88.2% (95% CI 66.2%–97.1% in cIAIs) for all Acinetobacter, and 72.7% (95% CI 54.5%–93.2% in HAP) to 100% (95% CI 25%–100.0% in cIAIs) for MDR Acinetobacter. For the comparators, it was 83.8% (95% CI 62.8%–95.9% in HAP) to 100% (95% CI 75%–100% in cIAIs and 25%–100.0% in RPs) and 88% (95% CI 66%–97% in HAP) to 100% (95% CI 25%–100% in cIAIs and 75%–100% in DFIs), respectively. CONCLUSION: These findings suggest that with appropriate monitoring, tigecycline may be a useful consideration for Acinetobacter infections alone or in combination with other anti-infective agents when other therapies are not suitable.
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spelling pubmed-56796782017-11-14 Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials Tucker, Hal Wible, Michele Gandhi, Ashesh Quintana, Alvaro Infect Drug Resist Original Research BACKGROUND: Acinetobacter infections, especially multidrug-resistant (MDR) Acinetobacter infections, are a global health problem. This study aimed to describe clinical outcomes in patients with confirmed Acinetobacter spp. isolates who were treated with tigecycline in randomized clinical trials. MATERIALS AND METHODS: Data from 14 multinational, randomized (open-label or double-blind), and active-controlled (except one) Phase III and IV studies were analyzed using descriptive statistics. RESULTS: A total of 174 microbiologically evaluable patients with Acinetobacter spp. infections (including MDR infections) were identified, and 95 received tigecycline to treat community-acquired pneumonia (CAP), diabetic foot infections (DFIs), hospital-acquired pneumonia (HAP), complicated intra-abdominal infections (cIAIs), infections with resistant pathogens (RPs), or complicated skin and skin-structure infections. The rate of cure of tigecycline for most indications was 70%–80%, with the highest (88.2%) in cIAIs. The rate of cure of the comparators was generally higher than tigecycline, but within each indication the 95% CIs for clinical cure for each treatment group overlapped. For most Acinetobacter isolates, the minimum inhibitory concentration of tigecycline was 0.12–2 μg/mL, with seven at 4 μg/mL and one at 8 μg/mL. The cure rate by tigecycline was 50% (95% CI 12.5%–87.5% in CAP) to 88.2% (95% CI 66.2%–97.1% in cIAIs) for all Acinetobacter, and 72.7% (95% CI 54.5%–93.2% in HAP) to 100% (95% CI 25%–100.0% in cIAIs) for MDR Acinetobacter. For the comparators, it was 83.8% (95% CI 62.8%–95.9% in HAP) to 100% (95% CI 75%–100% in cIAIs and 25%–100.0% in RPs) and 88% (95% CI 66%–97% in HAP) to 100% (95% CI 25%–100% in cIAIs and 75%–100% in DFIs), respectively. CONCLUSION: These findings suggest that with appropriate monitoring, tigecycline may be a useful consideration for Acinetobacter infections alone or in combination with other anti-infective agents when other therapies are not suitable. Dove Medical Press 2017-11-03 /pmc/articles/PMC5679678/ /pubmed/29138583 http://dx.doi.org/10.2147/IDR.S143306 Text en © 2017 Tucker et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Tucker, Hal
Wible, Michele
Gandhi, Ashesh
Quintana, Alvaro
Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
title Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
title_full Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
title_fullStr Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
title_full_unstemmed Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
title_short Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
title_sort efficacy of intravenous tigecycline in patients with acinetobacter complex infections: results from 14 phase iii and phase iv clinical trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5679678/
https://www.ncbi.nlm.nih.gov/pubmed/29138583
http://dx.doi.org/10.2147/IDR.S143306
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