Ciprofloxacin on Burned Patients

Bayer18 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns Bacterial Infections

Interventions

Ciprofloxacin (BAYO9867)DRUG

400 mg iv BID

Ciprofloxacin (BAYO9867)DRUG

400 mg iv TID

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (7)

Unnamed facility

Cesena, Forlì, Italy

Unnamed facility

Catania, Italy

Unnamed facility

Genova, Italy

Unnamed facility

Genova, Italy

Unnamed facility

Padova, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio

Time frame: >72 h post injury, 48h and 120 h after treatment

Data from ClinicalTrials.gov

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