NCT00668044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

April 24, 2008

Last Update Submit

October 26, 2009

Conditions

BurnsBacterial Infections

Keywords

Ciprofloxacin regimen in compromised patientsCiprofloxacinBurned patients

Outcome Measures

Primary Outcomes (1)

  • Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model

    >72 h post injury, 48h and 120 h after treatment

Secondary Outcomes (1)

  • Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio

    >72 h post injury, 48h and 120 h after treatment

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Ciprofloxacin (BAYO9867)

Arm 2

EXPERIMENTAL
Drug: Ciprofloxacin (BAYO9867)

Interventions

Ciprofloxacin (BAYO9867)DRUG

400 mg iv BID

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating female patients
  • Previous history of tendinopathy
  • Knowing syndrome of QTc prolongation
  • Impairment renal function
  • Hepatic insufficiency
  • Convulsion
  • Limited life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Cesena, Forlì, 47023, Italy

Location

Unknown Facility

Catania, 95126, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Genova, 16149, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Palermo, 90127, Italy

Location

Unknown Facility

Roma, 00144, Italy

Location

MeSH Terms

Conditions

BurnsBacterial Infections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Wounds and InjuriesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

November 1, 2002

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

IT(7)