The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
This study has been completed.
Information provided by (Responsible Party):
Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
First received: March 23, 2012
Last updated: March 19, 2015
Last verified: March 2015
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||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 Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
daptomycin 4-6mg/kg qd 10 - 14 days
Vancomycin 1g q12h 10 - 14 days
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01626560
|Hospital Universitário Evangelico de Curitiba
|Curitiba, Parana, Brazil, 80730150 |
Hospital Universitario Evangelico de Curitiba
No publications provided
||Felipe Francisco Bondan Tuon, PhD, Hospital Universitario Evangelico de Curitiba
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 23, 2012
||March 19, 2015
||Brazil: National Health Surveillance Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 23, 2015
Connective Tissue Diseases
Skin Diseases, Infectious