Trial Condition(s):
Burns, Bacterial Infections
Ciprofloxacin on Burned patients
Bayer Identifier:
10627
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations AUSL Cesena - Emilia Romagna Cesena, Italy, 47023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Martino Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL RM/C Roma - Lazio Roma, Italy, 00144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Villa Scassi Genova, Italy, 16149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Cannizzaro Catania, Italy, 95126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Civico Benfratelli-Di Cristina-Ascoli Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A population pharmacokinetics study of plasma levels of ciprofloxacin following a regimen of repeated dose I.V. administration (400 mg TID) on burn patients
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk modelTimeframe: >72 h post injury, 48h and 120 h after treatment
Secondary Outcome
- Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration RatioTimeframe: >72 h post injury, 48h and 120 h after treatment
Additional Information
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