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

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-045-16
• Date of registration: 03/03/2017
• Prospective Registration: Yes
• Primary sponsor: Theravance Biopharma Antibiotics, Inc. c/o Theravance Biopharma US, Inc,
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 07/04/2017
• Target sample size: 15
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=045-16
• Study type: Interventional
• Study design: This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (ie, vancomycin, daptomycin, or a β-lactam antibiotic with anti-staphylococcal activity [eg, nafcillin, oxacillin, cefazolin]) in the treatment of subjects with complicated S. aureus bacteremia and SA-RIE. The primary efficacy variable is clinical outcome at test of cure (TOC) in the microbiological intention-to-treat (mITT) analysis set, as assessed by a blinded independent efficacy adjudication committee (IEAC). Safety will be monitored by an independent data monitoring committee (IDMC).; Eligible subjects with confirmed S. aureus bacteremia will be randomized to receive open-label telavancin or standard IV therapy, in a ratio of 1:1 stratified by geographic region and a block variable created for conducting the interim analysis. Standard IV therapy, depending on the antibacterial susceptibility of the causative pathogen, will include vancomy
• Phase: III

Countries of recruitment

Argentina, Colombia, Czech Republic, Georgia, Germany, Hungary, Italy, Latvia, Mexico, Peru, Poland, Romania, Spain, United States

Contacts

• Name: Narda Lozada Malpartida
• Affiliation: SYNEOS HEALTH PERU S.R.L.

• Name: Narda Lozada Malpartida
• Affiliation: SYNEOS HEALTH PERU S.R.L.

Key inclusion & exclusion 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 < 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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Staphylococcal infection, unspecified site

-A490 Staphylococcal infection, unspecified site
Staphylococcal infection, unspecified site

A490

Intervention(s)

For subjects with normal renal function: Telavancin, 7.5 mg/kg, intravenously (IV) in either 5% dextrose injection (D5W); sterile water for injection; 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 function, 560 mg for those with moderate renal impairment, and 380 mg for subjects with severe renal impairment (see dosing table).
For subjects undergoing chronic hemodialysis, telavancin should be administered intravenously at a dose of 3.8 mg/kg (maximum dose of 380 mg) once daily by infusion over 60 minutes (following hemodialysis on hemodialysis days).

Secondary ID(s)

2014-004372-27

NCT02208063

Source(s) of Monetary Support

THERAVANCE BIOPHARMA ANTIBIOTICS, INC. C/O THERAVANCE BIOPHARMA US, INC

Ethics review

Status: Approved
Approval date: 22/09/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 29/11/2016
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 01/12/2016
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 02/05/2017
Contact:

[e-mail]

Hospital Nacional Arzobispo Loayza

88339014 - 3301677

[e-mail]

Status: Approved
Approval date: 22/06/2017
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]