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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01049022
First received: January 13, 2010
Last updated: February 7, 2014
Last verified: February 2014
  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


Condition Intervention Phase
Infections
Drug: Moxifloxacin (Avelox, BAY12-8039)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics (AUC) [ Time Frame: Day 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (Cmax) [ Time Frame: Day 1, 2, 3, 4 ] [ Designated as safety issue: No ]
  • joint assessments [ Time Frame: Screening, Day 2, 30 day follow up, 3 month followu up, 1 year follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: May 2010
Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
Single intravenous infusion of moxifloxacin administered over 60 minutes. The initial dose to be studied is 5 mg/kg body weight

  Eligibility

Ages Eligible for Study:   3 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049022

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
Orange, California, United States, 92868-3974
San Diego, California, United States, 92123-4282
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70118-5799
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
Kansas City, Missouri, United States, 64108-9898
United States, Ohio
Cincinnati, Ohio, United States, 45229-3039
Cleveland, Ohio, United States, 44106
Toledo, Ohio, United States, 43606
United States, Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01049022     History of Changes
Other Study ID Numbers: 11826, 2012-000737-40
Study First Received: January 13, 2010
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Pharmacokinetics

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014