Ciprofloxacin on Burned Patients
- Registration Number
- NCT00668044
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Ciprofloxacin (BAYO9867) - Arm 2 Ciprofloxacin (BAYO9867) -
- Primary Outcome Measures
Name Time Method Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model >72 h post injury, 48h and 120 h after treatment
- Secondary Outcome Measures
Name Time Method Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio >72 h post injury, 48h and 120 h after treatment