The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01626560
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : March 20, 2015
Information provided by (Responsible Party):
Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba

Brief Summary:
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 or disease Intervention/treatment Phase
Cellulitis Drug: Daptomycin Drug: Vancomycin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis
U.S. FDA Resources

Arm Intervention/treatment
Daptomicina Drug: Daptomycin
daptomycin 4-6mg/kg qd 10 - 14 days
Vancomycin Drug: Vancomycin
Vancomycin 1g q12h 10 - 14 days

Primary Outcome Measures :
  1. 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) ]
    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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01626560

Hospital Universitário Evangelico de Curitiba
Curitiba, Parana, Brazil, 80730150
Sponsors and Collaborators
Hospital Universitario Evangelico de Curitiba

Responsible Party: Felipe Francisco Bondan Tuon, PhD, Hospital Universitario Evangelico de Curitiba Identifier: NCT01626560     History of Changes
Other Study ID Numbers: daptocina
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents