None listed
Conditions
Interventions
TIGECICLINE Type of group
An initial intravenous dose of tigecycline 100 mg followed by.50 mg every 12 hours thereafter. After each infusion of tigecycline, patients will receive 100 ml of a placebo in the form of a normal saline solution.
Group name:vancomycin with aztreonam Type of group
1 g of vancomycin will be administered intravenously, followed by 2 g of aztreonam, every 12 hours.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Interned subjects of male and female sex, of> 18 years of age. The presumption of the need to institute intravenous antibiotic therapy for a period> 5 days. Patients in whom the existence of a complicated cutaneous and / or structural skin infection has been confirmed or suspected.
Exclusion criteria
Exclusion criteria: Those subjects who present a concomitant condition that, at the discretion of the researcher, could prevent an evaluation of the response or take a highly The possibility of completing the contemplated course of therapy is unlikely. Patients with some severe disorder that affects arterial blood circulation or a degree of insufficiency such that there is a probability of requiring amputation of the infected anatomical area within a period of one month. The presence of chronic infected diabetic ulcers of the foot or decubitus ulcers with a duration that lasts beyond the period of one week. Gangrene or necrotizing fasciitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Presence or absence of the following parameters: temperature, drainage and / or discharge, erythema, inflammation and / or hardening, localized heat, pain and / or sensitivity with palpation, degree of infection (width, length and depth), and heat. Measure:Evaluation of the clinical efficacy of tigecycline with vancomycin and aztreonam in the treatment of patients hospitalized with complicated cutaneous and / or structural skin infections. Timepoints:14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The observed result in the microbiological response at the level of the pathogen with respect to the pathogens of the basal level will be described according to the following definitions of bacteriological efficacy: eradication, persistence, superinfection and uncertainty. Measure:Microbiological efficacy between the treatment arms. Timepoints:14 days | — |
Countries
Canada, Peru, United States
Outcome results
None listed