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. 2017 Nov 3:10:401-417.
doi: 10.2147/IDR.S143306. eCollection 2017.

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

Hal Tucker  1 , Michele Wible  1 , Ashesh Gandhi  1 , Alvaro Quintana  1
Affiliations

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

Hal Tucker et al. Infect Drug Resist. .

Abstract

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: Acinetobacter; community-acquired pneumonia; complicated intra-abdominal infections; complicated skin and skin-structure infections; tigecycline.

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Conflict of interest statement

Disclosure HT, MW, and AQ are employees of Pfizer. AG was an employee of Pfizer at the time the study was conducted. This study used data from clinical trials that have been published previously. Information related to trial registration can be found in the original publications cited as references. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Clinical response in patients with Acinetobacter infections in the ME population. Notes: (A) Overall population; (B) by presence of MDR Acinetobacter; (C) by presence of bacteremia; (D) by prior antibiotic failure. Abbreviations: CAP, community-acquired pneumonia; cIAIs, complicated intra-abdominal infections; cSSSIs, complicated skin and skin-structure infections; DFIs, diabetic foot infections; HAP, hospital-acquired pneumonia; MDR, multidrug-resistant; ME, microbiologically evaluable; RPs, resistant pathogens; ROC, rate of cure.
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