The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Hospital Universitario Evangelico de Curitiba

Status and phase: Completed; Phase 4

Conditions: Cellulitis

Treatments: Drug: Daptomycin; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01626560

daptocina

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

7. 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.

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Daptomicina

Other group

Treatment:

Drug: Daptomycin

Vancomycin

Other group

Treatment:

Drug: Vancomycin