Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Hospital Universitario Evangelico de Curitiba.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba Identifier:
First received: March 23, 2012
Last updated: June 21, 2012
Last verified: June 2012

March 23, 2012
June 21, 2012
July 2012
July 2013   (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) ] [ 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.
Same as current
Complete list of historical versions of study NCT01626560 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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.

Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not yet recruiting
September 2013
July 2013   (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.

18 Years to 80 Years
Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
Hospital Universitario Evangelico de Curitiba
Not Provided
Not Provided
Hospital Universitario Evangelico de Curitiba
June 2012

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