Ciprofloxacin on Burned Patients - Full Text View

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:

MedlinePlus related topics: Bacterial Infections Burns

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

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

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:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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
Nucleic Acid Synthesis Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013