Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

Skin Diseases, Infectious Clinical Trial

Official title:

A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00430937
• Other study ID #: CCBC134A2402
• Status: Terminated
• Phase: Phase 3
• First received: February 1, 2007
• Last updated: July 10, 2012
• Start date: April 2006

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsFrance: French Health Products Safety Agency
• Study type: Interventional

Clinical Trial Summary

This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 194
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Subjects with a diagnosis of cSSTI

• Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria.

• Hospitalised subjects with clinical evidence of at least one of the following:I infected ulcers , major abscess. deep or extensive cellulitis, post-surgical / post-traumatic wound infection

• Presence of at least two of the following: drainage and/or discharge from the infection site, redness, swelling and/or hardened skin, heat and/or localised warmth, pain and/or tenderness to touch, presence of pus.

Exclusion criteria:

• cSSTIs of the following categories:

• Infected burns,

• Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely),

• Decubitus ulcers,

• Infected diabetic foot ulcers associated with osteomyelitis,

• Infected human or animal bites, superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess),

• Necrotising fasciitis or gangrene,

• cSSTI expected to require more than 14 days of intravenous antimicrobial therapy,

• Skin and/or skin structure infection that can be treated by surgery alone,

• Infections associated with a permanent prosthetic device that will not be removed within 2 days of study randomisation

• Subjects with documented bacteraemia at Baseline or those with shock or hypotension

• Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol

• Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours.

• Subjects admitted to the hospital for conditions associated with rhabdomyolysis or those with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin.

• Previously diagnosed disease of immune function. Human Immunodeficiency Virus (HIV) infected subjects without Acquired Immune Deficiency Syndrome (AIDS) may be enrolled.

• Subjects receiving oral steroids or receiving immunosuppressant drugs after organ transplant.

• Absence of purulent material for initial culture and Gram's stain. Subjects with cellulitis may be enrolled in the absence of purulent material, provided that infection with a Gram-positive organism is suspected.

• Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site with activity against Gram-positive pathogens, unless there is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy.

• cSSTI suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiology or on direct examination of a Gram-stained specimen.

• Subjects diagnosed with pneumonia or those with severe renal impairment or hepatic disease

• Previous history of hearing loss. Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Diseases
• Skin Diseases, Infectious
• Soft Tissue Infections

Intervention

Drug:
• Daptomycin
4 mg/kg intravenous once daily
• Vancomycin
1 g intravenous twice daily
• Teicoplanin
400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population.	Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).; Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.	Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks	No
Secondary	Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.	Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.; Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation.	Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks	No