Trial | NCT01626560  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
Study Started
Jul 31
2012
Primary Completion
Mar 31
2015
Study Completion
Mar 31
2015
Last Update
Mar 20
2015
Estimate

Drug Daptomycin

daptomycin 4-6mg/kg qd 10 - 14 days

Drug Vancomycin

Vancomycin 1g q12h 10 - 14 days

Daptomicina Other

Vancomycin Other

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Infections and other minor addition of erysipelas / cellulitis
Any recent use of antibacterial drug therapy (systemic or topical antibacterial drugs within 14 days of enrollment)
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.
Patients with known or suspected osteomyelitis.
Patients with suspected or confirmed septic arthritis.
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.
No Results Posted