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

Soft Tissue Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426933
• Other study ID #: DAP-HDSD-06-01
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2007
• Last updated: September 13, 2010
• Start date: January 2007
• Est. completion date: September 2007

Study information

• Verified date: September 2010
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Soft Tissue Infections

Intervention

Drug:
• Daptomycin

• Vancomycin

Locations

Country	Name	City	State
United States	Idaho Falls Infectious Diseases, PLLC	Idaho Falls	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response Rate at TOC
Secondary	difference between clinical response rates at EOT
Secondary	microbiological eradication rates