Bacterial Infections, Burns
Conditions
Keywords
Ciprofloxacin regimen in compromised patients, Ciprofloxacin, Burned patients
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.
Interventions
400 mg iv BID
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio | >72 h post injury, 48h and 120 h after treatment |
Countries
Italy
Outcome results
None listed