Endocarditis, BacterialPhase 4NCT00401960

Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.

A Phase 4 study testing Daptomycin in people with Endocarditis, Bacterial, run by Weill Medical College of Cornell University at 1 site in United States.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Endocarditis, Bacterial
What is being tested?: Daptomycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Oct 2008
Phase: Phase 4
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

Age 18 or over
Definite Enterococcal endocarditis, as defined by modified Duke criteria
Able to complete follow-up 3 and 6 weeks following completion of intravenous antibiotic therapy

Who cannot join

Pregnancy or breast feeding
Creatine phosphokinase levels over two times the upper limit of normal
Renal insufficiency or dialysis requirement.
Presence of chronic indwelling bloodstream catheters or foreign body devices suspected as primary or secondary sites of enterococcal infection unamenable to removal or replacement
Inability to discontinue or abstain from use of a HMG CoA reductase inhibitor during the study period.
Hypersensitivity to any of the study medications.
Any condition that, in the investigator's opinion, may interfere with protocol compliance including, but not limited to, active substance abuse and/or dementia.
Prosthetic valve endocarditis

Trial locations and contacts

1 site in 1 country.

United States1 site

NewYork-Presbyterian Hospital, Weill Cornell Campus
New York, New York, 10021

Other trials in United States

About this study

Official title: Open Label Study to Assess the Efficacy and Safety of Daptomycin in Combination With Anti-Cell Wall Active Therapy in the Treatment of Enterococcal Endocarditis

The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious.

Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes:

Safety.
The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.
Efficacy.
Clinical efficacy.

Time to clearance of bacteremia
Cure at 6 weeks following completion of antibiotic therapy
Mortality at 6 weeks following completion of antibiotic therapy

Microbiologic efficacy.

Peak and trough serum bactericidal titers
The minimum bactericidal concentration of Enterococci to daptomycin

We expect to enroll 40 patients over 2 years.

Conditions: Endocarditis, Bacterial
Being tested: Daptomycin
Keywords: Enterococcus, Daptomycin, Endocarditis
Medical subject headings: Endocarditis, Bacterial, Endocarditis

What participants receive

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

DaptomycinDrug
Also called Cubicin
daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis

Study groups in NCT00401960
Study group	Role	What they receive
Daptomycin adjunctive group	Experimental	Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving Receives: Drug: Daptomycin
standard of care	No intervention	Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician

What is being measured

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

Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
Measured: weekly
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria
Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline
Measured: weekly

Timeline

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

Sep 2006Oct 2008

First posted22 Nov 2006 (estimated)
Study startSep 2006
Primary completionOct 2008
Study completionOct 2008

Why it stopped: inadequate enrollment

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 Endocarditis, BacterialStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00401960
Sponsor's protocol ID: 0507008023
Status last verified: Apr 2017
First submitted: 20 Nov 2006
Last updated: 3 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: This was a pilot single arm study, for which IPD are not pertinent

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

Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
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Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
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Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
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RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
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All Endocarditis, Bacterial trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Study to Assess the Efficacy and Safety of Daptomycin in Combination With Anti-Cell Wall Active Therapy in the Treatment of Enterococcal Endocarditis
ClinicalTrials.gov ID: NCT00401960
Acronym / sponsor ID: 0507008023
Conditions: Endocarditis, Bacterial
Keywords: Enterococcus, Daptomycin, Endocarditis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: inadequate enrollment
Enrolment: 6 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: Sep 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 3 May 2017

Clinical summary

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

Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes:

Safety.
The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.
Efficacy.
Clinical efficacy.

Time to clearance of bacteremia
Cure at 6 weeks following completion of antibiotic therapy
Mortality at 6 weeks following completion of antibiotic therapy

Microbiologic efficacy.

Peak and trough serum bactericidal titers
The minimum bactericidal concentration of Enterococci to daptomycin

We expect to enroll 40 patients over 2 years.

Study design

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

Arm	Type	Receives
Daptomycin adjunctive group	Experimental	Drug: DaptomycinPatients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving
standard of care	No intervention	–Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician

Who may qualify

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

Key inclusion criteria (3 listed)

Age 18 or over
Definite Enterococcal endocarditis, as defined by modified Duke criteria
Able to complete follow-up 3 and 6 weeks following completion of intravenous antibiotic therapy

Key exclusion criteria (8 listed)

Pregnancy or breast feeding
Creatine phosphokinase levels over two times the upper limit of normal
Renal insufficiency or dialysis requirement.
Presence of chronic indwelling bloodstream catheters or foreign body devices suspected as primary or secondary sites of enterococcal infection unamenable to removal or replacement
Inability to discontinue or abstain from use of a HMG CoA reductase inhibitor during the study period.

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
DaptomycinAlso: Cubicindaptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis	Drug	Daptomycin adjunctive group

Primary outcome

Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)
Time frame: weekly
Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria
Time frame: weekly
Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline

Results and safety

Results posted to the registry on 3 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adjunctive Daptomycin Group	5	0
Standard of Care Group	1	1

Primary outcome: Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)

Time frame: weekly. Count of participants. Unit: Participants

Measure	Adjunctive Daptomycin Group n = 5	Standard of Care Group n = 1
Value	4	0

Population analysed: Study terminated due to insufficient enrollment; therefore data not sufficient for planned analysis

Primary outcome: Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria

Time frame: weekly. Count of participants. Unit: Participants

Measure	Daptomycin Adjunctive Group n = 5	Standard of Care n = 1
Elevated serum creatinine >= 30% above baseline	1	1
Elevate serum creatine kinase > 3X ULN	0	0

Population analysed: study terminated due to inadequate enrollment; therefore data not sufficient for planned analysis

Adverse events

Time frame: 2 years; however, study terminated due to lack of eligible study participants. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adjunctive Daptomycin Group	5 of 5 (100%)	0 of 5 (0%)	Not reported
Standard of Care Group	0 of 1 (0%)	0 of 1 (0%)	Not reported

Limitations and caveats (from the sponsor): study terminated due to insufficient enrollment; data therefore not analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. This was a pilot single arm study, for which IPD are not pertinent

Related trials for Endocarditis, Bacterial

Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis

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.

Kyu Y Rhee, MD, PhD principal investigator

Weill Medical College of Cornell University

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Daptomycin in people with Endocarditis, Bacterial, run by Weill Medical College of Cornell University 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 3 inclusion and 8 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 3 May 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 3 May 2017). 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 Any Grade 3 or 4 Toxicity (DAIDS Scale) (time frame: weekly). The study lists 2 primary outcomes in all. 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 NCT00401960.

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 3 May 2017.