Efficacy of intravenous tigecycline in patients with Acinetobacter complex infections: results from 14 Phase III and Phase IV clinical trials
Authors Tucker H, Wible M, Gandhi A, Quintana A
Received 6 June 2017
Accepted for publication 6 September 2017
Published 3 November 2017 Volume 2017:10 Pages 401—417
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Professor Suresh Antony
Hal Tucker, Michele Wible, Ashesh Gandhi, Alvaro Quintana
Pfizer Inc, Collegeville, PA, USA
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.
Keywords: tigecycline, Acinetobacter, community-acquired pneumonia, complicated intra-abdominal infections, complicated skin and skin-structure infections
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. 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. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]