Phase 3 N=761 Randomized Quadruple-blind Treatment

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Bacterial Pneumonia

Bottom Line

View on ClinicalTrials.gov: NCT00107952 ↗

Enrolled (actual)

761

Serious AEs

28.8%

Results posted

Dec 2009

Primary outcome: Primary: Clinical Response — 214; 221; 46; 68 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Telavancin (Drug); Vancomycin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cumberland Pharmaceuticals
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Response	214; 221; 46; 68; 56; 41	—

Summary

Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Eligibility Criteria

Inclusion Criteria

Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria

Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00107952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.