DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Diseases, Infectious; Soft Tissue Infections

Intervention: Daptomycin (Drug); Vancomycin (Drug); Teicoplanin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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

Clinical Details

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)

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

Primary outcome: 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.

Secondary outcome: Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: April 2006
Last updated: July 10, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017