The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

This study is not yet open for participant recruitment.

Verified June 2012 by Hospital Universitario Evangelico de Curitiba

Sponsor:

Information provided by (Responsible Party):

Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba

ClinicalTrials.gov Identifier:

NCT01626560

First received: March 23, 2012

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2012
Last Updated Date	June 21, 2012
Start Date ^ICMJE	July 2012
Estimated Primary Completion Date	July 2013 (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) ] [ 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.
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 Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 Arm (s)	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	Not yet recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	September 2013
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01626560
Other Study ID Numbers ^ICMJE	daptocina
Has Data Monitoring Committee	No
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
Information Provided By	Hospital Universitario Evangelico de Curitiba
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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