Overview

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