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Ciprofloxacin on Burned Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00668044
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Burns Bacterial Infections Drug: Ciprofloxacin (BAYO9867) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2002
Primary Completion Date : November 2003
Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: Ciprofloxacin (BAYO9867)
400 mg iv BID
Experimental: Arm 2 Drug: Ciprofloxacin (BAYO9867)
400 mg iv TID


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio [ Time Frame: >72 h post injury, 48h and 120 h after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668044


Locations
Italy
Cesena, Forlì, Italy, 47023
Catania, Italy, 95126
Genova, Italy, 16132
Genova, Italy, 16149
Padova, Italy, 35128
Palermo, Italy, 90127
Roma, Italy, 00144
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00668044     History of Changes
Other Study ID Numbers: 10627
COB
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by Bayer:
Ciprofloxacin regimen in compromised patients
Ciprofloxacin
Burned patients

Additional relevant MeSH terms:
Bacterial Infections
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors