Additional Clinical Experience
Experience with tigecycline outside of clinical trial data is currently limited. However, utilization for off-label indications has been reported in two small retrospective case series.[38,49] The first report described 25 patients who received tigecycline alone (n = 5) or in combination with other agents (n = 20) for MDR A. baumannii ventilator-associated pneumonia and/or bacteremia. A total of 21 out of 25 had clinical success, while 12 of 15 patients demonstrated microbial eradication. One patient with MDR A. baumannii pneumonia and bacteremia developed resistance to tigecycline during therapy and experienced clinical failure.
A separate study reported experience with tigecycline in 18 total cases of various infections with A. baumannii (n = 10) and other MDR Gram-negative bacilli (n = 8). Although many A. baumannii isolates remained susceptible to other antibiotics, greater than 50% demonstrated intermediate susceptibility to tigecycline. Among non- A. baumannii infections, six were ESBL positive (five Klebsiella pneumonia and one Escherichia coli), two of which were KPC enzymes (one confirmed and one inferred). The remaining two non- A. baumannii isolates were AmpC-producing Enterobacter cloacae.
The majority of patients (four out of five) in this analysis with A. baumannii intermediately resistant to tigecycline had death related to their infection, whereas none of four with susceptible isolates died. A similar trend was not found in patients with non- A. baumannii infections. Also, as has been experienced previously, one patient with A. baumannii developed resistance to tigecycline during therapy.
In addition to the above experiences, several cases of prolonged tigecycline therapy for serious infections due to MDR pathogens have been reported.[50,51,52,53,54] Two of these describe the management of bone infections with tigecycline in conjunction with surgical interventions.[50,51] Both cases of osteomyelitis were due to MDR pathogens ( A. baumanii and MBL-producing K. pneumoniae). The first occurred in a contract worker who sustained a grenade blast injury to the hip and femur while transporting soldiers in Iraq; the second case patient developed post-surgical mediastinitis following coronary artery bypass grafting. Both cases received prolonged courses of tigecycline (43 and 65 days, respectively) in conjunction with surgery, resulting in reported clinical cures.
Expert Rev Anti Infect Ther. 2008;6(5):557-567. © 2008 Expert Reviews Ltd.
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Cite this: Establishing the Role of Tigecycline in an era of Antimicrobial Resistance - Medscape - Oct 01, 2008.