The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

NCT01626560 | Completed Phase 4

• 1 other identifier: daptocina
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Study Arms (2)

Daptomicina

OTHER

Drug: Daptomycin

Vancomycin

OTHER

Drug: Vancomycin

Interventions

Daptomycin DRUG

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

Daptomicina

Vancomycin DRUG

Vancomycin 1g q12h 10 - 14 days

Vancomycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• \. 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.
• \. Patients with renal clearance \<30 mL / min. 12. Patients who are not susceptible to daptomycin or vancomycin. 13. Allergy to study medication.

Sponsors & Collaborators

• Hospital Universitario Evangelico de Curitiba: lead

Study Sites (1)

Hospital Universitário Evangelico de Curitiba

Curitiba, Paraná, 80730150, Brazil

Location

MeSH Terms

Conditions

Cellulitis

Interventions

Daptomycin; Vancomycin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: June 22, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

BR (1)