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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
Sponsor:
Information provided by (Responsible Party):
Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba

Tracking Information
First Submitted Date  ICMJE March 23, 2012
First Posted Date  ICMJE June 22, 2012
Last Update Posted Date March 20, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01626560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cellulitis
Intervention  ICMJE
  • Drug: Daptomycin
    daptomycin 4-6mg/kg qd 10 - 14 days
  • Drug: Vancomycin
    Vancomycin 1g q12h 10 - 14 days
Study Arms  ICMJE
  • Daptomicina
    Intervention: Drug: Daptomycin
  • Vancomycin
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01626560
Other Study ID Numbers  ICMJE daptocina
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
Study Sponsor  ICMJE Hospital Universitario Evangelico de Curitiba
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Evangelico de Curitiba
Verification Date March 2015

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