Micah Jacobs, MD1, Ryan Shields, PharmD, MS2, Ziba Ansari-Orlando, PharmD3, Candice Clay, PhD4, Anna Osmukhina, PhD4, Bibiana Castaneda-Ruiz, MD4, 1Romano, Pontzer and Associates; 2University of Pittsburgh; 3Marin General Hospital; 4Theravance Biopharma US, Inc.

Meeting: Hospital Medicine 2018; April 8-11; Orlando, Fla.

Abstract number: 101

Categories: Hospital Medicine 2018, Other, Research

Keywords: , ,

Background: TOUR™ is a multicenter study designed to characterize the real-world population characteristics and clinical outcomes associated with telavancin (TLV) use through retrospective medical chart review. Telavancin is a lipoglycopeptide antibacterial active against gram-positive pathogens, including methicillin-sensitive and -resistant Staphylococcus aureus (MSSA and MRSA). In the US, TLV is approved for hospital-acquired (HABP) and ventilator-associated bacterial pneumonia (VABP) when alternative treatments are not suitable. Telavancin demonstrated comparable efficacy to vancomycin in a limited number of patients with HABP/VABP and concurrent S. aureus bacteremia.

Methods: Between January 1, 2015, and March 1, 2017, 46 US sites reported data from 1058 patients. Patient demographics, antibiotic treatments, pathogens, dosage, duration of therapy, clinical outcome, and adverse events (AEs) were analyzed in the subset with lower respiratory tract infections (LRTIs). Clinical outcomes were assessed by the investigator through medical chart review.

Results: There were 98 patients treated for LRTIs, including 42 (42.9%) HABP, 34 (34.7%) unspecified pneumonia, 7 (7.1%) VABP, and 15 (15.3%) other LRTIs. Other LRTIs included community-acquired pneumonia, cystic fibrosis pulmonary exacerbation, empyema, lung abscess, and septic pulmonary emboli. Median patient age was 59 years (range 18−88) with 34 patients (35.4%) ≥65 years; 55 (56.1%) were male, 74 (75.5%) were White, and the median body mass index was 25.3 kg/m2 (range 15.6−57.9 kg/m2). Of the 91 patients (92.9%) in whom an organism was identified, MRSA was the most common pathogen (n = 52, 53.1%). The median TLV dose was 9.1 mg/kg (range, 2.9−14.2 mg/kg) and a median of 735.9 mg/day (range 250−1461.6 mg/day). The median duration of treatment was 8 days (range 1−84 days). Telavancin was initiated after failed prior therapy in 77 patients (78.6%); 15 patients (15.3%) failed 2 or more prior therapies. Overall, 52 (53.1%) patients had a positive clinical response at the end of TLV treatment (cured or improved to step-down oral therapy), 15 (15.3%) failed treatment, and 31 (31.6%) were not evaluable (indeterminate, missing data, or undocumented). Respective outcomes for patients with HABP and VABP were 23 (54.8%) and 5 (71.4%) positive clinical response, 9 (21.4%) and 1 (14.3%) failed, and 10 (23.8%) and 1 (14.3%) were not evaluable. Sixteen patients experienced at least 1 AE of interest (renal AE or AE leading to discontinuation or fatal outcome) and 9 discontinued TLV due to an AE. Of 9 patients with serious AEs of interest, 6 had a fatal outcome unrelated to TLV treatment and 3 recovered or resolved the infection.

Conclusions: These real-world data confirm the efficacy of once-daily TLV observed in clinical trials for the treatment of HABP/VABP patients. Furthermore, these results show that TLV is mainly used as a second line therapy and identify the utility of TLV in treating other types of LRTIs.

To cite this abstract:

Jacobs, M; Shields, R; Ansari-Orlando, Z; Clay, C; Osmukhina, A; Castaneda-Ruiz, B. REAL-WORLD TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS IN THE TELAVANCIN OBSERVATIONAL USE REGISTRY (TOUR™). Abstract published at Hospital Medicine 2018; April 8-11; Orlando, Fla. Abstract 101. Accessed September 19, 2019.

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