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

BACKGROUND

infections, especially multidrug-resistant (MDR) infections, are a global health problem. This study aimed to describe clinical outcomes in patients with confirmed 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 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 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 , and 72.7% (95% CI 54.5%-93.2% in HAP) to 100% (95% CI 25%-100.0% in cIAIs) for MDR . 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 infections alone or in combination with other anti-infective agents when other therapies are not suitable.