Ciprofloxacin on Burned Patients

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668044
• Other study ID #: 10627
• Secondary ID: COB
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: October 26, 2009
• Start date: November 2002
• Est. completion date: November 2003

Study information

• Verified date: October 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Burns

Intervention

Drug:
• Ciprofloxacin (BAYO9867)
400 mg iv BID
• Ciprofloxacin (BAYO9867)
400 mg iv TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio		>72 h post injury, 48h and 120 h after treatment	No

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