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Ciprofloxacin on Burned Patients

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668044
First received: April 24, 2008
Last updated: October 26, 2009
Last verified: October 2009
History of Changes

April 24, 2008
October 26, 2009
November 2002
November 2003   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668044 on ClinicalTrials.gov Archive Site
Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio [ Time Frame: >72 h post injury, 48h and 120 h after treatment ] [ Designated as safety issue: No ]
Same as current
 
 
 
Ciprofloxacin on Burned Patients
A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients

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.
 
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Burns
  • Bacterial Infections
  • Drug: Ciprofloxacin (BAYO9867)
    400 mg iv BID
  • Drug: Ciprofloxacin (BAYO9867)
    400 mg iv TID
  • Experimental: Arm 1
    Intervention: Drug: Ciprofloxacin (BAYO9867)
  • Experimental: Arm 2
    Intervention: Drug: Ciprofloxacin (BAYO9867)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2003
November 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00668044
10627, COB
No
Therapeutic Area Head, Bayer HealthCare AG
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP