BacteremiaPhase 3NCT02208063

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

A Phase 3 study testing Telavancin, Vancomycin and Daptomycin in people with Bacteremia, run by Cumberland Pharmaceuticals at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bacteremia
What is being tested?: Telavancin, Vancomycin and Daptomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited States
Study dates: Dec 2014to 12 Apr 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 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)

Show all 9Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Remington-Davis Clinical Research
Columbus, Ohio, 43215

Other trials in United States

About this study

Official title: A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including Infective Endocarditis

Conditions: Bacteremia
Being tested: Telavancin, Vancomycin, Daptomycin, Synthetic penicillin, Cefazolin
Keywords: Bacteremia, Staphylococcus aureus
Medical subject headings: Bacteremia, Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelavancinDrug
VancomycinDrug
DaptomycinDrug
Also called Cubicin
Synthetic penicillinDrug
Also called Nafcillin, Oxacillin, Cloxacillin
CefazolinDrug

Study groups in NCT02208063
Study group	Role	What they receive
Telavancin	Experimental	7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes Receives: Drug: Telavancin
Standard of care	Active comparator	Vancomycin, Daptomycin, synthetic penicillin or Cefazolin Receives: Drug: Vancomycin; Drug: Daptomycin; Drug: Synthetic penicillin; Drug: Cefazolin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:
1. Subject alive at TOC
2. Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)
3. No evidence of microbiological persistence or relapse
4. No new foci of metastatic S. aureus infection after Day 8
Measured: Up to 8 weeks
Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response
Measured: 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
After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection
Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201412 Apr 2018

First posted4 Aug 2014 (estimated)
Study startDec 2014
Primary completion12 Apr 2018
Study completion12 Apr 2018

Why it stopped: Halted due to lack of statistical power. No safety concerns identified.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BacteremiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02208063
Sponsor's protocol ID: 0112
Status last verified: Feb 2020
First submitted: 31 Jul 2014
Last updated: 17 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Oral Switch in Pediatric Bloodstream Infections
Bloodstream Infection, Bacteremia Sepsis
Recruiting
From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis
Infective Endocarditis (IE)
RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
Not yet recruitingPhase 2
THiamine for Recovery In Vulnerable Early-life Infections
Meningitis, Bacteremia
RecruitingObservational study
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Blood Stream Infection, Blood Stream Infections

All Bacteremia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including Infective Endocarditis
ClinicalTrials.gov ID: NCT02208063
Acronym / sponsor ID: 0112
Conditions: Bacteremia
Keywords: Bacteremia, Staphylococcus aureus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Halted due to lack of statistical power. No safety concerns identified.
Enrolment: 121 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2014 (actual)
Primary completion: 12 Apr 2018 (actual)
Study completion: 12 Apr 2018 (actual)
First posted: 4 Aug 2014 (estimated)
Results: Posted 17 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Telavancin	Experimental	Drug: Telavancin7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
Standard of care	Active comparator	Drug: Vancomycin, Drug: Daptomycin, Drug: Synthetic penicillin, Drug: CefazolinVancomycin, Daptomycin, synthetic penicillin or Cefazolin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

18 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:
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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telavancin	Drug	Telavancin
Vancomycin	Drug	Standard of care
DaptomycinAlso: Cubicin	Drug	Standard of care
Synthetic penicillinAlso: Nafcillin, Oxacillin, Cloxacillin	Drug	Standard of care
Cefazolin	Drug	Standard of care

Primary outcome

Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
Time frame: Up to 8 weeks
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

3 secondary outcomes

Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
Time frame: Up to 8 weeks
Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
Time frame: 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
Time frame: Day 8

Results and safety

Results posted to the registry on 17 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telavancin	60	48
Standard of Care	61	50

Primary outcome: Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)

Time frame: Up to 8 weeks. Count of participants. Unit: Participants

Measure	Telavancin n = 47	Standard of Care n = 52
Cure	22	27
Failure	19	21
Indeterminate	6	4

Population analysed: One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 38 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telavancin	16 of 58 (27.6%)	29 of 58 (50%)	3 of 58
Standard of Care	13 of 60 (21.7%)	25 of 60 (41.7%)	5 of 60

Limitations and caveats (from the sponsor): At the interim analysis, study was deemed to be inadequately powered \& terminated prematurely.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bacteremia

RecruitingPhase 4
Oral Switch in Pediatric Bloodstream Infections
Bloodstream Infection, Bacteremia Sepsis
Recruiting
From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis
Infective Endocarditis (IE)
RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
Not yet recruitingPhase 2
THiamine for Recovery In Vulnerable Early-life Infections
Meningitis, Bacteremia
RecruitingObservational study
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Blood Stream Infection, Blood Stream Infections

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Cumberland Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telavancin, Vancomycin and Daptomycin in people with Bacteremia, run by Cumberland Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC) (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02208063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020; AzTrials last refreshed its copy on 26 Oct 2026.