Ciprofloxacin on Burned Patients

This study has been completed.
Information provided by:
Bayer Identifier:
First received: April 24, 2008
Last updated: October 26, 2009
Last verified: October 2009
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
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00668044

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG 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
Burned patients

Additional relevant MeSH terms:
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on November 27, 2015