Trial Condition(s):

Burns, Bacterial Infections

Ciprofloxacin on Burned patients

Bayer Identifier:

10627

ClinicalTrials.gov Identifier:

NCT00668044

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
18
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

AUSL Cesena - Emilia Romagna

Cesena, Italy, 47023

Status
Completed
 
Locations

A.O.U. San Martino

Genova, Italy, 16132

Status
Completed
 
Locations

ASL RM/C Roma - Lazio

Roma, Italy, 00144

Status
Completed
 
Locations

Ospedale Villa Scassi

Genova, Italy, 16149

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

A.O. Cannizzaro

Catania, Italy, 95126

Status
Completed
 
Locations

A.O. Civico Benfratelli-Di Cristina-Ascoli

Palermo, Italy, 90127

Status
Completed
 

Trial Design