EUCTR2012-000737-40-Outside-EU/EEA
Active, not recruiting
Not Applicable
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- o medical condition specified as the purpose of this study is to describe the pharmacokinetics of moxifloxacin in children for future antibiotic treatment.
- Sponsor
- Bayer HealthCare Pharmaceuticals
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The informed consent must be signed before any study specific tests or procedures are done
- •Males or females, ages 3 months through 14 years inclusive
- •Receiving antibiotics for suspected or proven infection
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Body weight greater than 45 kg
- •Patients taking anti\-seizure medications within 30 days of moxifloxacin dosing
- •Known or suspected allergy to quinolones
- •History of tendon disease/disorder related to quinolone treatment
- •Severe, life\-threatening disease with a life expectancy of less than 48 hours and/or known rapidly fatal underlying disease (death expected within 2 months)
- •Abnormal musculoskeletal evaluation at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
- •Cardiac arrhythmia
- •Evidence of renal or hepatic disease, based on laboratory findings (serum creatinine, total bilirubin \>1\.5 or ALT \> 3 times upper limit of normal) and physical exam
- •Patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents
- •Patients taking any medication known to increase the QT interval, eg, amiodarone, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, disopyuramide, dofetilide, droperidol, halofantrine, haloperidol, ibutilide, levomethadyl, mesoradazine, methadone, pimozide, procainamide, quinidine, sotalol, terfenadine
Outcomes
Primary Outcomes
Not specified
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