Ciprofloxacin on Burn Patients
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns
Intervention: Cipro (Ciprofloxacin, BAY Q3939) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
Secondary outcome: Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Catania 95126, Italy
Genova 16132, Italy
Roma 00144, Italy
Genova 16149, Italy
Padova 35128, Italy
Palermo 90127, Italy
Cesena, Forlì 47023, Italy
Additional Information
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Starting date: November 2002
Ending date: November 2003
Last updated: April 27, 2008
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