Ciprofloxacin on Burned Patients
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: November 2003
Intervention(s) in this Clinical Trial
- Drug: Ciprofloxacin (BAYO9867)
- 400 mg iv BID
- Drug: Ciprofloxacin (BAYO9867)
- 400 mg iv TID
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Arm 1
- Experimental: Arm 2
Outcome Measures for this Clinical Trial
Primary Measures
- Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
- Time Frame: >72 h post injury, 48h and 120 h after treatment
Safety Issue?: No
- Time Frame: >72 h post injury, 48h and 120 h after treatment
Secondary Measures
- Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
- Time Frame: >72 h post injury, 48h and 120 h after treatment
Safety Issue?: No
- Time Frame: >72 h post injury, 48h and 120 h after treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668044
Study ID Number: 10627
ClinicalTrials.gov Identifier: NCT00668044
Health Authority: Italy: Ethics Committee
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00668044
