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

Phase 2

Completed

• Conditions: Soft Tissue Infections

• Registration Number: NCT00426933
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-25
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-13
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Response Rate at TOC

Secondary Outcome Measures

Name	Time	Method
difference between clinical response rates at EOT
microbiological eradication rates

Trial Locations

Locations (1)

Idaho Falls Infectious Diseases, PLLC; 🇺🇸 Idaho Falls, Idaho, United States