The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Cellulitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626560
• Other study ID #: daptocina
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2012
• Last updated: March 19, 2015
• Start date: July 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital Universitario Evangelico de Curitiba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cellulitis

Intervention

Drug:
• Daptomycin
daptomycin 4-6mg/kg qd 10 - 14 days
• Vancomycin
Vancomycin 1g q12h 10 - 14 days

Locations

Country	Name	City	State
Brazil	Hospital Universitário Evangelico de Curitiba	Curitiba	Parana

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Evangelico de Curitiba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes