check_circleStudy Completed
Burns, Bacterial Infections
Bayer Identifier:
10627
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Ciprofloxacin on Burned patients
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
18Trial Dates
November 2002 - November 2003Phase
Phase 3Could I Receive a placebo
NoProducts
Cipro IV (Ciprofloxacin, BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | AUSL Cesena - Emilia Romagna | Cesena, 47023, Italy |
Completed | A.O.U. San Martino | Genova, 16132, Italy |
Completed | ASL RM/C Roma - Lazio | Roma, 00144, Italy |
Completed | Ospedale Villa Scassi | Genova, 16149, Italy |
Completed | A.O. di Padova | Padova, 35128, Italy |
Completed | A.O. Cannizzaro | Catania, 95126, Italy |
Completed | A.O. Civico Benfratelli-Di Cristina-Ascoli | Palermo, 90127, Italy |
Primary Outcome
- Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk modeldate_rangeTime Frame:>72 h post injury, 48h and 120 h after treatmentenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratiodate_rangeTime Frame:>72 h post injury, 48h and 120 h after treatmentenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2