The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Phase 4

Completed

• Conditions: Cellulitis
• Interventions: Drug: Daptomycin; Drug: Vancomycin

• Registration Number: NCT01626560
• Lead Sponsor: Hospital Universitario Evangelico de Curitiba

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 available

Study Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Study Start: 2012-07
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daptomicina	Daptomycin	-
Vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Cytokine levels	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)	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.

Trial Locations

Locations (1)

Hospital Universitário Evangelico de Curitiba; 🇧🇷 Curitiba, Parana, Brazil