None listed
Conditions
Interventions
For subjects with normal renal function: Telavancin, 7.5 mg/kg, intravenously (IV) in either 5% dextrose injection (D5W)
or 0.9% sodium chloride
in 100 to 250 mL over 60 (+/- 10) minutes, once every 24 hours for 2 to 6 weeks. For subjects weighing more than 100 kg, the daily telavancin dose should not exceed 750 mg for those with normal renal
Sponsors
Theravance Biopharma Antibiotics, Inc. c/o Theravance Biopharma US, Inc,
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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)
Countries
Argentina, Colombia, Czech Republic, Georgia, Germany, Hungary, Italy, Latvia, Mexico, Peru, Poland, Romania, Spain, United States
Contacts
Public ContactNarda Malpartida
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed