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

نویسندگان

  • Hal Tucker
  • Michele Wible
  • Ashesh Gandhi
  • Alvaro Quintana
چکیده

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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Rapid decrease in the prevalence of macrolide-resistant group A streptococci due to the appearance of two epidemic clones in Cantabria (Spain).

after launch, 61% of the tigecycline prescriptions were ’off label’, especially for patients with ventilator-associated pneumonia (VAP) due to MDR Acinetobacter spp. (D. Curcio, F. Fernández and F. Duret, unpublished data). The high concentration in alveolar cells (77.5-fold higher than serum), the increase in carbapenem-resistant Acinetobacter spp. in Argentina (54%), the lack of medical evide...

متن کامل

In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for hospital acquired pneumonia

The in vitro activity of tigecycline was evaluated against 819 baseline pathogens isolated from 383 patients enrolled in the phase 3 clinical trial investigating the efficacy of tigecycline in hospital acquired pneumonia (HAP). The trials were global, enrolling patients in 27 countries. Tigecycline was active against the most prevalent pathogens in HAP, including gram-positive and gram-negative...

متن کامل

Relative Gene Expression of RND-Type Efflux Pumps in Tigecycline Resistant Acinetobacter Baumannii Isolated from Training Hospitals in Tehran, Iran

Background: Appearance of multi-drug resistance (MDR) Acinetobacter baumannii imposes limitation on antibiotic therapy in patients. Detection of MDR A. baumannii can play a crucial role to prevent MDR strains spreading in hospitals. The aim of this study was determination the efflux pumps gene expression in tigecyclin resistance strains in collected isolates from selected training hospitals in ...

متن کامل

In vitro activity of tigecycline as a therapeutic option against multidrug-resistant Acinetobacter spp.

The study was performed to detect the in vitro activity of tigecycline in multidrug-resistant Acinetobacter isolates from patients in Hacettepe University Adult Hospital, Turkey. The microorganisms were isolated from clinical specimens of patients with respiratory and bloodstream infections. Thirty (66.7%) of the 45 inpatients were in ICUs. In vitro activity of imipenem, meropenem, ceftazidime,...

متن کامل

Population pharmacokinetics of tigecycline in patients with complicated intra-abdominal or skin and skin structure infections.

Tigecycline, a first-in-class expanded glycylcycline antimicrobial agent, has demonstrated efficacy in the treatment of complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal (cIAI) infections. A population pharmacokinetic (PK) model for tigecycline was developed for patients with cSSSI or cIAI enrolled in two phase 2 clinical trials, and the influence of selecte...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 10  شماره 

صفحات  -

تاریخ انتشار 2017