A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects with Saphylococcus aureus Bacteremia including infective Endocarditis

Not Applicable

• Conditions: -A490 Staphylococcal infection, unspecified site; Staphylococcal infection, unspecified site; A490

• Registration Number: PER-045-16
• Lead Sponsor: Theravance Biopharma Antibiotics, Inc. c/o Theravance Biopharma US, Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-03
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Male or female at least 18 years old at the time of consent
2. Subject has signed an informed consent form. If a subject is unable to give consent, when legally permitted, consent must be obtained from the subject’s legally acceptable representative.
3. At least one blood culture positive for S. aureus obtained within 48 hours before
randomization, referred to as the qualifying blood culture (QBC)
4. In addition to the QBC, subject must have at least one of the following signs or symptoms of bacteremia:
• Temperature ≥ 38.0°C
• White blood cell (WBC) count > 10,000 or < 4,000 cells/μL, or > 10% immature neutrophils (bands) regardless of total peripheral WBC count
• Tachycardia (heart rate > 90 bpm)
• Tachypnea (respiratory rate >20 breaths/min)
• Hypotension (systolic blood pressure <90 mmHg)
• Signs and symptoms of localized catheter-related infection (tenderness and/or pain, erythema, swelling, purulent exudate within 2 cm of entry site)

Exclusion Criteria

1. Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 48 hours within 7 days before randomization
EXCEPTION: Documented resistance to the prior systemic antibacterial therapy, confirmed by a microbiological laboratory report (pathogens non-susceptible to telavancin, or non-susceptible to daptomycin and a vancomycin MIC >1 mcg/mL are not permitted)
2. Requirement or anticipated requirement of potentially effective (anti-staphylococcal) non-study systemic antibiotics during the study
3. Presence of an infection source (eg, intravascular line, abscess, infected prosthetic material, wound) that will not be managed or controlled (eg, removal of line, drainage of abscess, removal of infected prosthesis, or debridement of wound) within the first 3 days of study drug treatment
4. Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring)

Study & Design

• Study Type: Interventional
• Study Design: Not specified