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

NCT ID: NCT00426933

Last Updated: 2010-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-09-30

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

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.

The main criteria for evaluation will be:

• Efficacy
• Safety
• Microbiologic eradication

Conditions

Soft Tissue Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Daptomycin

Intervention Type: DRUG

Vancomycin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Informed consent obtained

2. Male or female ≥18 years of age

3. If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test

4. Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment

5. Gram-positive infecting pathogen

6. Physician determination that vancomycin would be the initial treatment of choice

7. 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;

8. Creatinine clearance of ≥50 mL/min.

Exclusion Criteria

1. MSSA

2. Known or suspected bacteremia, osteomyelitis, or endocarditis

3. 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;

4. Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);

5. Necrotizing infections or concomitant gangrene;

6. Myositis with or without skin and skin structure infections;

7. Hemodialysis or peritoneal dialysis;

8. BMI ≥40 kg/m2;

9. Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug

10. Patients admitted for rhabdomyolysis including drug overdose

11. Neutropenic patients with absolute neutrophil count ≤500 cells/mm3

12. Known HIV-infected patients with CD4 count ≤200 cells/ mm3;

13. Baseline CPK values ≥2 X ULN (upper limit of normal);

14. Has received an investigational drug within 30 days of study entry;

15. Known to be allergic or intolerant to study medications;

16. unlikely to comply with study procedures

17. Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Cubist Pharmaceuticals, Inc.

Principal Investigators

Richard Nathan, D.O.

Role: PRINCIPAL_INVESTIGATOR

Idaho Falls Infectious Diseases, PLLC

Locations

Idaho Falls Infectious Diseases, PLLC

Idaho Falls, Idaho, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 18662172 (View on PubMed)

Other Identifiers

DAP-HDSD-06-01

Identifier Type: -

Identifier Source: org_study_id