Ciprofloxacin on Burned Patients

Bayer

Status and phase: Completed; Phase 3

Conditions: Burns; Bacterial Infections

Treatments: Drug: Ciprofloxacin (BAYO9867)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668044

COB

10627

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Ciprofloxacin (BAYO9867)

Drug: Ciprofloxacin (BAYO9867)

Arm 2

Experimental group

Treatment:

Drug: Ciprofloxacin (BAYO9867)

Drug: Ciprofloxacin (BAYO9867)