NCT00055198

Brief Summary

The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_3

Status
terminated

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

December 19, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2004

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

February 20, 2003

Last Update Submit

June 12, 2017

Conditions

Gram-Positive Bacterial Infections

Keywords

Gram positive bacterial infectionsexpanded access programresistant infectionsbacteremiaBacterial and fungal infectionsbacterial infections

Interventions

daptomycinDRUG

Eligibility Criteria

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

You may qualify if:

  • Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics\*\*
  • Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related).
  • Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid.
  • Unable to receive any other standard commercially available antibacterial therapy for the infection.

You may not qualify if:

  • Creatinine clearance less than 40 mL/min\*\*
  • Hemodialysis or peritoneal dialysis
  • Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections
  • Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)\*\*
  • Central nervous system infection
  • Pulmonary infection.
  • (\*\*) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gram-Positive Bacterial InfectionsBacteremiaMycosesBacterial Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsSepsisSystemic 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2003

First Posted

February 21, 2003

Study Start

December 19, 2002

Primary Completion

January 26, 2004

Study Completion

January 26, 2004

Last Updated

June 14, 2017

Record last verified: 2017-06