Back to resultsThe Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
Primary Purpose
Cellulitis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Daptomycin
Vancomycin
Sponsored by
About this trial
This is an interventional basic science trial for Cellulitis
Eligibility 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.
Sites / Locations
- Hospital Universitário Evangelico de Curitiba
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Daptomicina
Vancomycin
Arm Description
Outcomes
Primary Outcome Measures
Cytokine levels
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01626560
First Posted
March 23, 2012
Last Updated
March 19, 2015
Sponsor
Hospital Universitario Evangelico de Curitiba
1. Study Identification
Unique Protocol Identification Number
NCT01626560
Brief Title
The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Evangelico de Curitiba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomicina
Arm Type
Other
Arm Title
Vancomycin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Description
daptomycin 4-6mg/kg qd 10 - 14 days
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 1g q12h 10 - 14 days
Primary Outcome Measure Information:
Title
Cytokine levels
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital Universitário Evangelico de Curitiba
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80730150
Country
Brazil
12. IPD Sharing Statement
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The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
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