The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Daptomicina

Group Type OTHER

Daptomycin

Intervention Type DRUG

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

Vancomycin

Group Type OTHER

Vancomycin

Intervention Type DRUG

Vancomycin 1g q12h 10 - 14 days

Interventions

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Daptomycin

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

Intervention Type DRUG

Vancomycin

Vancomycin 1g q12h 10 - 14 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No