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
  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.


Condition Intervention Phase
Burns
Bacterial Infections
Drug: Ciprofloxacin (BAYO9867)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio [ Time Frame: >72 h post injury, 48h and 120 h after treatment ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ciprofloxacin (BAYO9867)
400 mg iv BID
Experimental: Arm 2 Drug: Ciprofloxacin (BAYO9867)
400 mg iv TID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00668044     History of Changes
Other Study ID Numbers: 10627, COB
Study First Received: April 24, 2008
Last Updated: October 26, 2009
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Bacterial Infections
Burns
Wounds and Injuries
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014