Ciprofloxacin on Burned Patients

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.

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Key information

Conditions

Burns Bacterial Infections Bacterial Infections and Mycoses Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cesena, Forlì, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciprofloxacin (BAYO9867)

Drug

400 mg iv BID

Primary outcomes

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

Secondary outcomes

Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio

Time frame: >72 h post injury, 48h and 120 h after treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Apr 28, 2008
Registry last updated: Oct 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed