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

NCT ID: NCT01049022

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-08-31

Brief Summary

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

Conditions

Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moxifloxacin (Avelox, BAY12-8039), Cohort 1

Group Type: EXPERIMENTAL

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type: DRUG

Single intravenous (IV) infusion of moxifloxacin administered over 60 minutes, at an initial dosage of 5 milligram per kilogram per body weight (mg/kg/BW) with dose escalation to 6 mg/kg in subjects of age 6 years (yrs) to less than or equal to (\<=) 14 years.

Moxifloxacin (Avelox, BAY12-8039), Cohort 2

Group Type: EXPERIMENTAL

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type: DRUG

Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 7 mg/kg/BW with dose escalation to 8 mg/kg in subjects of age 2 years to less than (\<) 6 years; dose escalation was based on evaluations of the pharmacokinetic (PK) and safety data from the subjects in a preceding cohort.

Moxifloxacin (Avelox, BAY12-8039), Cohort 3

Group Type: EXPERIMENTAL

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type: DRUG

Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 9 mg/kg/BW with dose escalation to 10 mg/kg in subjects of age 3 months to \< 2 years; dose escalation was based on evaluations of the PK and safety data from the subjects in a preceding cohort.

Interventions

Moxifloxacin (Avelox, BAY12-8039)

Single intravenous (IV) infusion of moxifloxacin administered over 60 minutes, at an initial dosage of 5 milligram per kilogram per body weight (mg/kg/BW) with dose escalation to 6 mg/kg in subjects of age 6 years (yrs) to less than or equal to (\<=) 14 years.

Intervention Type: DRUG

Moxifloxacin (Avelox, BAY12-8039)

Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 7 mg/kg/BW with dose escalation to 8 mg/kg in subjects of age 2 years to less than (\<) 6 years; dose escalation was based on evaluations of the pharmacokinetic (PK) and safety data from the subjects in a preceding cohort.

Intervention Type: DRUG

Moxifloxacin (Avelox, BAY12-8039)

Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 9 mg/kg/BW with dose escalation to 10 mg/kg in subjects of age 3 months to \< 2 years; dose escalation was based on evaluations of the PK and safety data from the subjects in a preceding cohort.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Little Rock, Arkansas, United States

Orange, California, United States

San Diego, California, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Kansas City, Missouri, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Toledo, Ohio, United States

Salt Lake City, Utah, United States

Countries

United States

References

Wirth S, Emil SGS, Engelis A, Digtyar V, Criollo M, DiCasoli C, Stass H, Willmann S, Nkulikiyinka R, Grossmann U; MOXIPEDIA Study Group. Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study. Pediatr Infect Dis J. 2018 Aug;37(8):e207-e213. doi: 10.1097/INF.0000000000001910.

Reference Type: DERIVED

PMID: 29356761 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2012-000737-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11826

Identifier Type: -

Identifier Source: org_study_id