In Vitro Activity of Tigecycline against Isolates from Patients Enrolled in Phase 3 Clinical Trials of Treatment for Complicated Skin and Skin‐Structure Infections and Complicated Intra‐Abdominal Infections

Abstract

The in vitro activity of tigecycline was evaluated against 4913 baseline pathogens isolated from 1986 patients enrolled in 4 pivotal phase 3 clinical trials. The trials, which were conducted in 38 countries worldwide, involved patients with complicated skin and skin-structure infections or complicated intra-abdominal infections. Tigecycline was active against the most prevalent pathogens for each infection type, including gram-positive and gram-negative strains of both aerobic and anaerobic bacteria (MICs, < or =2 microg/mL for most pathogens). The spectrum of activity of tigecycline included important pathogens, such as Staphylococcus aureus (including methicillin-resistant S. aureus), Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, and Bacteroides fragilis. A few genera, such as Pseudomonas aeruginosa and members of the tribe Proteeae, were generally less susceptible to tigecycline than were other gram-negative pathogens. The susceptibility of the pathogens to tigecycline was similar for isolates obtained from patients enrolled in the studies of complicated skin and skin-structure infection or of complicated intra-abdominal infection. For most pathogens, the susceptibility to tigecycline was similar across all geographic regions. The excellent expanded broad-spectrum activity of tigecycline demonstrated in vitro against clinical isolates confirmed its potential utility for pathogens associated with complicated skin and skin-structure infections or complicated intra-abdominal infections.

Validation and Reproducibility Assessment of Tigecycline MIC Determinations by Etest

“…Tigecycline was recently approved worldwide for use in patients with complicated skin and skin structure infections and complicated intra-abdominal infections. The broad spectrum of activity of tigecycline against gram-negative and gram-positive pathogens matched that seen with classical tetracyclines (1,4,9,13). However, in contrast to the classical tetracyclines, tigecycline was not subject to efflux through the tetracycline specific efflux pumps or affected by the ribosomal protection mechanism of tetracycline resistance (11,14,18).…”

“…However, in contrast to the classical tetracyclines, tigecycline was not subject to efflux through the tetracycline specific efflux pumps or affected by the ribosomal protection mechanism of tetracycline resistance (11,14,18). In addition, tigecycline showed a good profile against important clinical pathogens: methicillin-resistant Staphylococcus aureus, glycopeptide-intermediate resistant S. aureus (and heterogeneous glycopeptide-intermediate resistant S. aureus), vancomycin-resistant enterococci, penicillin-resistant Streptococcus pneumoniae, and resistant gram-negative aerobic bacilli producing extended-spectrum ␤-lactamases (4,(12)(13)(14)18).…”

Pharmacokinetic/pharmacodynamic (PK/PD) considerations in the management of Gram-positive bacteraemia

“…Tigecycline not only has in vitro activity against MRSA and vancomycinresistant E. faecium, but also common Gram-negative aerobes, atypical pathogens and anaerobic pathogens, with the exception of Pseudomonas aeruginosa and Proteus spp. [77][78][79][80][81]. As with other tetracycline derivatives, tigecycline binds to the 30S ribosomal subunit, inhibiting protein synthesis and bacterial growth.…”

Comparative In Vitro Antimicrobial Activity of Tigecycline, a New Glycylcycline Compound, in Freshly Prepared Medium and Quality Control

“…Bacterial isolates obtained during the clinical trials were tested and reported using freshly prepared medium which was less than 12 h old at the time of MIC tray production (6).…”