NCT00426933

Brief Summary

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

8 months

First QC Date

January 23, 2007

Last Update Submit

September 13, 2010

Conditions

Soft Tissue Infections

Keywords

cSSSIMRSA

Outcome Measures

Primary Outcomes (1)

  • Clinical Response Rate at TOC

Secondary Outcomes (2)

  • difference between clinical response rates at EOT

  • microbiological eradication rates

Interventions

DaptomycinDRUG
VancomycinDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained
  • Male or female ≥18 years of age
  • If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
  • Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
  • Gram-positive infecting pathogen
  • Physician determination that vancomycin would be the initial treatment of choice
  • At least three clinical signs and symptoms associated with the cSSSI:
  • Pain;
  • Tenderness to palpation;
  • Elevated Temperature;
  • Elevated White blood count;
  • Swelling and/or induration;
  • Erythema (\>1 cm beyond edge of wound or abscess);
  • Pus formation;
  • Creatinine clearance of ≥50 mL/min.

You may not qualify if:

  • MSSA
  • Known or suspected bacteremia, osteomyelitis, or endocarditis
  • Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
  • Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
  • Necrotizing infections or concomitant gangrene;
  • Myositis with or without skin and skin structure infections;
  • Hemodialysis or peritoneal dialysis;
  • BMI ≥40 kg/m2;
  • Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug
  • Patients admitted for rhabdomyolysis including drug overdose
  • Neutropenic patients with absolute neutrophil count ≤500 cells/mm3
  • Known HIV-infected patients with CD4 count ≤200 cells/ mm3;
  • Baseline CPK values ≥2 X ULN (upper limit of normal);
  • Has received an investigational drug within 30 days of study entry;
  • Known to be allergic or intolerant to study medications;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idaho Falls Infectious Diseases, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Related Publications (1)

  • Katz DE, Lindfield KC, Steenbergen JN, Benziger DP, Blackerby KJ, Knapp AG, Martone WJ. A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria. Int J Clin Pract. 2008 Sep;62(9):1455-64. doi: 10.1111/j.1742-1241.2008.01854.x. Epub 2008 Jul 25.

    PMID: 18662172DERIVED

MeSH Terms

Conditions

Soft Tissue Infections

Interventions

DaptomycinVancomycin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsGlycopeptidesGlycoconjugatesCarbohydrates

Study Officials

  • Richard Nathan, D.O.

    Idaho Falls Infectious Diseases, PLLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 25, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

US(1)