Indications of a new antibiotic in clinical practice: results of the tigecycline initial use registry

Abstract

Tigecycline is the first of a new class of antibiotics named glycylcyclines and it was approved for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Notwithstanding this, tigecycline's pharmacological and microbiological profile which includes multidrug-resistant pathogens encourages physicians' use of the drug in other infections. We analyzed, during the first months after its launch, the tigecycline prescriptions for 113 patients in 12 institutions. Twenty-five patients (22%) received tigecycline for approved indications, and 88 (78%) for "off label" indications (56% with scientific support and 22% with limited or without any scientific support). The most frequent "off label" use was ventilator associated pneumonia (VAP) (63 patients). The etiology of infections was established in 105 patients (93%). MDR-Acinetobacter spp. was the microorganism most frequently isolated (50% of the cases). Overall, attending physicians reported clinical success in 86 of the 113 patients (76%). Our study shows that the "off label" use of tigecycline is frequent, especially in VAP. due to MDRAcinetobacter spp., where the therapeutic options are limited (eg: colistin). Physicians must evaluate the benefits/ risks of using this antibiotic for indications that lack rigorous scientific support.

Clinical experience with tigecycline as treatment for serious infections in elderly and critically ill patients

“…Similarly in Argentina, 78% of the tigecycline prescriptions were for off-label use during its first month of commercial use, especially for VAP (61%) due to MDR Acinetobacter spp infection. 14 In our study, cases with HAP were older (mean age 78 years), were more frequently admitted to the intensive care unit (76.3%), and had higher SOFA score (mean 8.6). Prior antibiotic use was found in almost all cases.…”

In Vivo Pharmacodynamic Profile of Tigecycline against Phenotypically Diverse Escherichia coli and Klebsiella pneumoniae Isolates

“…Currently, tigecycline is FDA approved for complicated intraabdominal infections (cIAI) and complicated skin-skin structure infections (15). With high susceptibilities demonstrated in surveillance studies (2) and positive clinical outcomes shown in trial data from subpopulations infected with ESBL-producing Enterobacteriaceae (6,23), tigecycline has been increasingly utilized as a treatment option. Given these occurrences and the few available studies describing the exposure-response relationship for the treatment of gram-negative organisms (15,19,21), it seems reasonable to uncover the pharmacodynamics of tigecycline.…”

Diagnosis and antimicrobial treatment of invasive infections due to multidrug-resistant Enterobacteriaceae. Guidelines of the Spanish Society of Infectious Diseases and Clinical Microbiology

“…Four studies including 118 patients with infections caused by ESBLproducing enterobacteria provided some additional data. [244][245][246][247] The most frequent infections were cIAI, cSSTI and HAP. Clinical response rates ranged between 63% and 81%, but the percentage of patients receiving combination therapy was not always specified.…”