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OpenTrials
Completed

NCT Number: NCT01626560

The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitário Evangelico de Curitiba

Curitiba, Paraná, 80730150, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

daptomycin

Drug

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

Vancomycin

Drug

Vancomycin 1g q12h 10 - 14 days

Primary outcomes

  1. Cytokine levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Evangelico de Curitiba

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2012
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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