A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

NCT02208063 | Terminated Phase 3 Results DMC

• 1 other identifier: 0112
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).

Conditions

Bacteremia

Keywords

Bacteremia; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)

  The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC). 1. Alive at TOC 2. Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC 3. No evidence of microbiological persistence of relapse 4. No new foci of metastatic S. aureus infection after Day 8

  Up to 8 weeks

Secondary Outcomes (3)

• Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population

  Up to 8 weeks

• Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population

  Up to 8 weeks

• Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations

  Day 8

Study Arms (2)

Telavancin

EXPERIMENTAL

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Drug: Telavancin

Standard of care

ACTIVE COMPARATOR

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Drug: Vancomycin; Drug: Daptomycin; Drug: Synthetic penicillin; Drug: Cefazolin

Interventions

Telavancin DRUG

Telavancin

Vancomycin DRUG

Standard of care

Daptomycin DRUG

Also known as: Cubicin

Standard of care

Synthetic penicillin DRUG

Also known as: Nafcillin, Oxacillin, Cloxacillin

Standard of care

Cefazolin DRUG

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization
• 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)
• Tachycardia (heart rate \> 90 bpm)
• Tachypnea (respiratory rate \> 20 breaths/min)
• Hypotension (systolic blood pressure \< 90 mmHg)
• Signs or symptoms of localized catheter-related infection
• At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia.

You may not qualify if:

• Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy
• Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment
• Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator \[ICD\]), permanent pacemaker, or cardiac valve support ring)
• Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted
• Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted
• Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

Remington-Davis Clinical Research

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Bacteremia; Staphylococcal Infections

Interventions

telavancin; Vancomycin; Daptomycin; Nafcillin; Oxacillin; Cloxacillin; Cefazolin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; Thiazines

Limitations and Caveats

At the interim analysis, study was deemed to be inadequately powered \& terminated prematurely.

Results Point of Contact

• Title: Senior Director of Clinical and Regulatory Affairs
• Organization: Cumberland Pharmaceuticals Inc.

ahaeberle@cumberlandpharma.com

615-255-0068

Study Officials

• Medical Monitor

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: December 1, 2014
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)