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Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Primary Purpose

Soft Tissue Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Daptomycin

Vancomycin

About this trial

This is an interventional treatment trial for Soft Tissue Infections focused on measuring cSSSI, MRSA

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
unlikely to comply with study procedures
Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment

Sites / Locations

Idaho Falls Infectious Diseases, PLLC

Outcomes

Primary Outcome Measures

Clinical Response Rate at TOC

Secondary Outcome Measures

difference between clinical response rates at EOT

microbiological eradication rates

Full Information

NCT ID

NCT00426933

First Posted

January 23, 2007

Last Updated

September 13, 2010

Sponsor

Cubist Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT00426933

Brief Title

Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Official Title

Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cubist Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Infections

Keywords

cSSSI, MRSA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Daptomycin

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Primary Outcome Measure Information:

Title

Clinical Response Rate at TOC

Secondary Outcome Measure Information:

Title

difference between clinical response rates at EOT

Title

microbiological eradication rates

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; unlikely to comply with study procedures Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Nathan, D.O.

Organizational Affiliation

Idaho Falls Infectious Diseases, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Idaho Falls Infectious Diseases, PLLC

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18662172

Citation

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.

Results Reference

derived

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Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

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