The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug.

• Conditions: o medical condition specified as the purpose of this study is to describe the pharmacokinetics of moxifloxacin in children for future antibiotic treatment.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000737-40-Outside-EU/EEA
• Lead Sponsor: Bayer HealthCare Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-20
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 36

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
• Pregnancy
• Clinically relevant findings in the ECG
• Participation in another clinical study during the preceding 30 days(last treatment from previous study to first treatment of new study)
• Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety
• Patients taking another fluoroquinolone at the time of planned moxifloxacin dosing

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to describe the pharmacokinetics of moxifloxacin in children of different ages, in order to determine a dose which will provide a similar exposure as seen in adults treated with the approved therapeutic dose of 400 mg;Secondary Objective: The secondary objectives of this study are to assess the safety and tolerability of single dose intravenous moxifloxacin in children, particularly with regard to cardiovascular and musculoskeletal safety.;Primary end point(s): Pharmacokinetics (AUC)<br>Pharmacokinetics (Cmax)<br>joint assessments<br>;Timepoint(s) of evaluation of this end point: Pharmacokinetics (AUC) - Time Frame: Day 1, 2, 3, 4 <br>Pharmacokinetics (Cmax) - Time Frame: Day 1, 2, 3, 4 <br>Joint Assessments - Time Frame: Screening, Day 2, 30 day follow up, 3 month followu up, 1 year follow up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse events collection<br>;Timepoint(s) of evaluation of this end point: Adverse events collection - Time Frame: within 10 days. Joint abnormalities followed until resolution, up to 5 years.<br>