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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Cipro (Ciprofloxacin, BAY Q3939)
  • 400mg three times a day i.v.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a

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

Secondary Measures

• Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
  • Time Frame: >72 h post injury, 48h and 120 h after treatment
    Safety Issue?: 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

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

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

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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