Ciprofloxacin on Burned Patients

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Ciprofloxacin

Criteria

Inclusion Criteria:

• Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,

• Hospitalization for burning injury since at least 72h during hyper metabolic phase

• Active infections microbiological confirmed

• Signed informed consent

Exclusion Criteria:

• Pregnant or lactating female patients

• Previous history of tendinopathy

• Knowing syndrome of QTc prolongation

• Impairment renal function

• Hepatic insufficiency

• Convulsion

• Limited life expectancy