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The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

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ClinicalTrials.gov Identifier: NCT01626560
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : March 20, 2015
Information provided by (Responsible Party):

March 23, 2012
June 22, 2012
March 20, 2015
July 2012
March 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01626560 on ClinicalTrials.gov Archive Site
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The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
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
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.
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Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Drug: Daptomycin
    daptomycin 4-6mg/kg qd 10 - 14 days
  • Drug: Vancomycin
    Vancomycin 1g q12h 10 - 14 days
  • Daptomicina
    Intervention: Drug: Daptomycin
  • Vancomycin
    Intervention: Drug: Vancomycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2015
March 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
Hospital Universitario Evangelico de Curitiba
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Hospital Universitario Evangelico de Curitiba
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP