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

摘要

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.