Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival
G Ralph Corey1, Marin H Kollef, Andrew F Shorr
1Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.
Abstract:
U.S. Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia recommends the use of diagnostic criteria according to American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines and the use of a primary endpoint of 28-day all-cause mortality. The effect of applying these guidelines on outcomes of phase III nosocomial pneumonia studies of telavancin was evaluated in a post hoc analysis. ATS/IDSA criteria were applied in a blind fashion to the original all-treated (AT) group. Clinical cure rates at final follow-up were determined in the refined AT and clinically evaluable (CE) groups (ATS/IDSA-AT and ATS/IDSA-CE, respectively). The exploratory endpoint of 28-day survival was evaluated for the ATS/IDSA-AT group. Noninferiority of telavancin versus vancomycin was demonstrated, with similar cure rates in the ATS/IDSA-AT (59% versus 59%) and ATS/IDSA-CE (83% versus 80%) groups. Cure rates favored telavancin in ATS/IDSA-CE patients where Staphylococcus aureus was the sole pathogen (86% versus 75%). Overall, 28-day survival rates were similar in the telavancin (76%) and vancomycin (77%) groups but lower in telavancin-treated patients with preexisting moderate-to-severe renal impairment (creatinine clearance [CLCR] of <50 ml/min). Telavancin should be administered to patients with moderate-to-severe renal impairment only if treatment benefit outweighs the risk or if no suitable alternatives are available.
Insights
This study evaluated telavancin for bacterial nosocomial pneumonia using new FDA guidelines. Telavancin showed noninferiority to vancomycin, with similar cure rates, but caution is advised for patients with renal impairment.
Area of Science:
- Infectious Diseases
- Clinical Pharmacology
- Regulatory Science
Background:
- U.S. FDA draft guidance recommends specific diagnostic criteria (ATS/IDSA) and endpoints (28-day mortality) for nosocomial pneumonia trials.
- Telavancin is an antibiotic used for bacterial nosocomial pneumonia.
- A post hoc analysis was conducted to assess the impact of the proposed FDA guidelines on existing Phase III telavancin trial data.
Purpose of the Study:
- To evaluate the effect of applying American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) criteria on outcomes in Phase III nosocomial pneumonia studies of telavancin.
- To assess clinical cure rates and 28-day survival using the refined criteria and endpoints.
Main Methods:
- A post hoc analysis applied ATS/IDSA criteria to the all-treated (AT) group from original telavancin Phase III studies.
- Clinical cure rates were determined for the refined ATS/IDSA-AT and clinically evaluable (ATS/IDSA-CE) groups.
- Exploratory analysis of 28-day survival was performed for the ATS/IDSA-AT group.
Main Results:
- Telavancin demonstrated noninferiority to vancomycin, with similar clinical cure rates in both ATS/IDSA-AT (59% vs. 59%) and ATS/IDSA-CE (83% vs. 80%) groups.
- Telavancin showed improved cure rates in ATS/IDSA-CE patients with *Staphylococcus aureus* as the sole pathogen (86% vs. 75%).
- Overall 28-day survival rates were comparable (76% vs. 77%), but lower in telavancin-treated patients with moderate-to-severe renal impairment (CLCR <50 ml/min).
Conclusions:
- Applying ATS/IDSA guidelines to Phase III telavancin trials confirmed noninferiority to vancomycin for bacterial nosocomial pneumonia.
- Telavancin efficacy may be particularly notable in specific patient subgroups, such as those with *S. aureus* monoinfection.
- Caution is warranted when using telavancin in patients with moderate-to-severe renal impairment, balancing potential benefits against risks.
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