NCT00093067

Brief Summary

The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2002

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

September 30, 2004

Last Update Submit

February 9, 2017

Conditions

Bacterial EndocarditisBacteremia

Keywords

Gram-positive bacterial infectionsStaph AureusendocarditisbacteremiaCubist

Outcome Measures

Primary Outcomes (1)

  • To demonstrate that daptomycin is not inferior to comparator in the treatment of S. aureus bacteremia and IE as assessed by the Independent External Adjudication Committee (IEAC) Outcome at Test of Cure (TOC) in the Intention-to-Treat (ITT) population.

Secondary Outcomes (9)

  • To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome at End of Treatment (EOT) in the ITT population.

  • To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome at EOT and TOC in the Per Protocol (PP) population.

  • To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome for each of the diagnoses defined by the IEAC at EOT in the ITT population.

  • To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome for each of the diagnoses defined by the Investigator at EOT in the ITT population.

  • To compare microbiologic eradication rates between daptomycin and comparator.

  • +4 more secondary outcomes

Interventions

daptomycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented S. aureus bacteremia within 2 calendar days of the first dose of study medication

You may not qualify if:

  • Subjects with a creatinine clearance of less than 30 ml/min
  • Subjects with pneumonia
  • Pregnant, nursing, or lactating
  • Documented history of allergy or intolerance to penicillin or vancomycin
  • Subjects with osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fowler VG Jr, Boucher HW, Corey GR, Abrutyn E, Karchmer AW, Rupp ME, Levine DP, Chambers HF, Tally FP, Vigliani GA, Cabell CH, Link AS, DeMeyer I, Filler SG, Zervos M, Cook P, Parsonnet J, Bernstein JM, Price CS, Forrest GN, Fatkenheuer G, Gareca M, Rehm SJ, Brodt HR, Tice A, Cosgrove SE; S. aureus Endocarditis and Bacteremia Study Group. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med. 2006 Aug 17;355(7):653-65. doi: 10.1056/NEJMoa053783.

    PMID: 16914701RESULT

  • Bhavnani SM, Rubino CM, Ambrose PG, Drusano GL. Daptomycin exposure and the probability of elevations in the creatine phosphokinase level: data from a randomized trial of patients with bacteremia and endocarditis. Clin Infect Dis. 2010 Jun 15;50(12):1568-74. doi: 10.1086/652767.

    PMID: 20462352DERIVED

MeSH Terms

Conditions

Endocarditis, BacterialBacteremiaGram-Positive Bacterial InfectionsStaphylococcal InfectionsEndocarditis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsCardiovascular InfectionsCardiovascular DiseasesHeart DiseasesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and Proteins

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

September 30, 2004

First Posted

October 1, 2004

Study Start

March 1, 2002

Primary Completion

November 1, 2004

Study Completion

February 1, 2005

Last Updated

February 13, 2017

Record last verified: 2017-02