Trial Condition(s):

Infections

Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients

Bayer Identifier:

11826

ClinicalTrials.gov Identifier:

NCT01049022

EudraCT Number:

2012-000737-40

Study Completed

Trial Purpose

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. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children

Inclusion Criteria
- Males or females, ages 3 months through 14 years inclusive
 - Receiving antibiotics for suspected or proven infection
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, or ALT, > 1.5 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 days1 (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

Trial Summary

Enrollment Goal
31
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

University Hospitals Case Medical Center

Cleveland, United States, 44106

Status
Completed
 
Locations

Children's Hospital of New Orleans

New Orleans, United States, 70118-5799

Status
Terminated
 
Locations

Arkansas Children's Hospital

Little Rock, United States, 72202

Status
Completed
 
Locations

University of Louisville

Louisville, United States, 40202

Status
Completed
 
Locations

Children's Hospital Boston

Boston, United States, 02115

Status
Terminated
 
Locations

Children's Mercy Hospital

Kansas City, United States, 64108-9898

Status
Terminated
 
Locations

Children's Hospital of Orange County

Orange, United States, 92868-3974

Status
Completed
 
Locations

Rady Children's Hospital–San Diego

San Diego, United States, 92123-4282

Status
Completed
 
Locations

Toledo Children's Hospital

Toledo, United States, 43606

Status
Completed
 
Locations

University of Utah Medical Center

Salt Lake City, United States, 84132

Status
Terminated
 
Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, United States, 45229-3039

Status
Terminated
 

Trial Design