MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE THE SAFETY AND EFFICACY OF TIGECICLINE WITH VANCOMYCIN / AZTREONAM IN THE TREATMENT OF COMPLICATED INFECTIONS OF SKIN AND SKIN STRUCTURE.

Phase 1

• Conditions: -L08; L08

• Registration Number: PER-003-03
• Lead Sponsor: ABORATORIOS WYETH S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-02-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>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.<br>Timepoints:14 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>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.<br>Measure:Microbiological efficacy between the treatment arms.<br>Timepoints:14 days<br>