search
Back to results

Ciprofloxacin on Burned Patients

Primary Purpose

Burns, Bacterial Infections

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ciprofloxacin (BAYO9867)
Ciprofloxacin (BAYO9867)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Ciprofloxacin regimen in compromised patients, Ciprofloxacin, Burned patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model

Secondary Outcome Measures

Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio

Full Information

First Posted
April 24, 2008
Last Updated
October 26, 2009
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00668044
Brief Title
Ciprofloxacin on Burned Patients
Official Title
A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Bacterial Infections
Keywords
Ciprofloxacin regimen in compromised patients, Ciprofloxacin, Burned patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin (BAYO9867)
Intervention Description
400 mg iv BID
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin (BAYO9867)
Intervention Description
400 mg iv TID
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
Time Frame
>72 h post injury, 48h and 120 h after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Cesena
State/Province
Forlì
ZIP/Postal Code
47023
Country
Italy
City
Catania
ZIP/Postal Code
95126
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Genova
ZIP/Postal Code
16149
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Roma
ZIP/Postal Code
00144
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Ciprofloxacin on Burned Patients

We'll reach out to this number within 24 hrs