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The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

This study is not yet open for participant recruitment.
Verified June 2012 by Hospital Universitario Evangelico de Curitiba
Sponsor:
Information provided by (Responsible Party):
Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
ClinicalTrials.gov Identifier:
NCT01626560
First received: March 23, 2012
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both groups according to levels of the cytokines evaluated.


Condition Intervention Phase
Cellulitis
 Drug: Daptomycin
Drug: Vancomycin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Daptomycin in the Levels of IL-1, IL-6 and TNF in Patients With Complicated Cellulitis/Erisipela in Comparison With Vancomycin or Oxacillin

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis
U.S. FDA Resources

Further study details as provided by Hospital Universitario Evangelico de Curitiba:

Primary Outcome Measures:
  • Cytokine levels [ Time Frame: AUC will be calculated with multiple time points over a period of 14 days (0, 4, 8, 12 , 16, 24, 48, 72, 96, 120 and 168 hours post‐dose) ] [ Designated as safety issue: Yes ]
    The results of cytokine levels will be evaluated after completion of antibiotic therapy, when testing will take place in the laboratory. Thus the measurement of cytokines will not be used to evaluate the clinical outcome.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Daptomicina Drug: Daptomycin
daptomycin 4-6mg/kg qd 10 - 14 days
Vancomycin Drug: Vancomycin
Vancomycin 1g q12h 10 - 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eligible patients will be age between 18 and 65 who required hospitalization and parenteral antimicrobial therapy
  2. Clinical documentation of cellulitis / erysipela
  3. Documentation of a minimal surface area 75 cm2 based on the length and / or width of the redness, swelling and / or induration
  4. Documented fever, defined as oral or tympanic temperature greater than or equal to 38 ° C

Exclusion Criteria:

  1. Infections and other minor addition of erysipelas / cellulitis
  2. Any recent use of antibacterial drug therapy (systemic or topical antibacterial drugs within 14 days of enrollment)
  3. Patients with clinical conditions that alter the interpretation of the primary outcome as patients with neutropenia or compromised immune function, as HIV infection, autoimmune disorders, use of corticosteroids.
  4. Patients with known or suspected osteomyelitis.
  5. Patients with suspected or confirmed septic arthritis.
  6. Patients with complicated skin infections, such as diabetic foot infections. 7. Chronic use of antipyretic drugs (eg, daily use of naproxen).

8. Less than 18 years of age. 9. pregnancy 10. Patients with mixed infections of Gram-negative or be deleted since the therapy of gram-negative can influence the levels of cytokines.

11. Patients with renal clearance <30 mL / min. 12. Patients who are not susceptible to daptomycin or vancomycin. 13. Allergy to study medication.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626560

Locations
Brazil
Hospital Universitário Evangelico de Curitiba Not yet recruiting
Curitiba, Parana, Brazil, 80730150
Contact: felipe f tuon, phd     554188521893     flptuon@gmail.com    
Sponsors and Collaborators
Hospital Universitario Evangelico de Curitiba
  More Information

No publications provided

Responsible Party: Felipe Francisco Bondan Tuon, PhD, Hospital Universitario Evangelico de Curitiba
ClinicalTrials.gov Identifier: NCT01626560     History of Changes
Other Study ID Numbers: daptocina
Study First Received: March 23, 2012
Last Updated: June 21, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
 Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013