Cubicin(R) for Complicated Post-surgical Wound Infections | NCT00651131

Studies
Cubicin(R) for Complicated Post-surgical Wound Infections

NCT00651131

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status

Terminated

Last Update Posted

Aug 30, 2017Actual

Enrollment

69Actual

Phase

Phase 4

Conditions

Wound Infections

Interventions

daptomycin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DAP-4PSW-03-03	Other Identifier	Cubist Study Number

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated due to slow enrollment

Expanded Access Info

Start Date

Jun 1, 2004Actual

Primary Completion Date

Mar 1, 2005Actual

Completion Date

Mar 1, 2005Actual

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2017

Last Update Posted Date

Aug 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections

Detailed Description

A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Name	Type	Description	Arm Group Labels	Other Names
daptomycin	Drug	daptomycin i.v. 4 mg/kg q24h for 7-14 days		Cubicin daptomycin for injection Cubicin (daptomycin for injection)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigator's assessment of clinical response based on improvement of signs and symptoms		End of Therapy

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events		first dose to end of therapy
eradication of pathogens isolated at admission		End of Therapy
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Read and signed informed consent form
female of childbearing potential, negative pregnancy test result
Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
Onset of surgical wound infection within 30 days after surgery
At least three clinical signs and symptoms of skin infection

Exclusion Criteria:

previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
Uncomplicated surgical infections (eg, stitch abscesses)
osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
Any type of space infection
Conditions requiring surgical removal of wound infection
necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
Foreign material involved in the post-surgical wound infection
Known to be allergic or intolerant to study medication
Creatinine Clearance (CLCR) <30 mL/min
history of neurological disease (eg, Guillain-Barré, multiple sclerosis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014946	Wound Infection

ID	Term
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D017576	Daptomycin
D007267	Injections

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D055666	Lipopeptides

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