check_circleStudy Completed

Burns, Bacterial Infections

Bayer Identifier:

10627

ClinicalTrials.gov Identifier:

NCT00668044

EudraCT Number:

Not Available

EU CT Number:

Not Available
Ciprofloxacin on Burned patients

Trial 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.

Key Participants Requirements

Sex

Both

Age

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

Trial summary

Enrollment Goal
18
Trial Dates
November 2002 - November 2003
Phase
Phase 3
Could I Receive a placebo
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
AUSL Cesena - Emilia RomagnaCesena, 47023, Italy
Completed
A.O.U. San MartinoGenova, 16132, Italy
Completed
ASL RM/C Roma - LazioRoma, 00144, Italy
Completed
Ospedale Villa ScassiGenova, 16149, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
A.O. CannizzaroCatania, 95126, Italy
Completed
A.O. Civico Benfratelli-Di Cristina-AscoliPalermo, 90127, Italy

Primary Outcome

  • Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
    date_rangeTime Frame:
    >72 h post injury, 48h and 120 h after treatment
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    Safety Issue:
    no

Secondary Outcome

  • Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
    date_rangeTime Frame:
    >72 h post injury, 48h and 120 h after treatment
    enhanced_encryption
    Safety Issue:
    no

Trial design

A population pharmacokinetics study of plasma levels of ciprofloxacin following a regimen of repeated dose I.V. administration (400 mg TID) on burn patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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