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

NCT01049022 | Completed Phase 1

• 2 other identifiers: 118262012-000737-40
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 11

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

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Area under the Concentration-Time Curve (AUC) of Moxifloxacin and its Metabolites

  The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

  Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)

• Maximum Observed Drug Concentration in Plasma (Cmax) of Moxifloxacin and its Metabolites

  Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

  Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)

• Number of Subjects With Treatment Emergent Findings on Joint Assessment: Baseline

  Joint assessment included formal physical examination of all joints with special care and attention to the weight-bearing joints (such as, knees, hips, and ankles) and to the shoulder girdle. All joints were examined for pain/tenderness, evidence of inflammation (i.e., redness, warmth, deformity, swelling or ballotable fluid), loss of function (to the extent this could be assessed in younger children and infants), and any restrictions to expected active/passive range of motion. An incidence count was reported as the number of subjects with at least one finding at baseline, regardless of side.

  Baseline

• Number of Subjects With Treatment Emergent Findings on Joint Assessment : At any Time During Treatment

  Joint assessment included formal physical examination of all joints with special care and attention to the weight-bearing joints (such as, knees, hips, and ankles) and to the shoulder girdle. An incidence count was reported as the number of subjects with at least one finding at any time during treatment, regardless of side.

  Day 1 up to Year 5 (follow-up)

Secondary Outcomes (7)

• Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin and its Metabolites

  Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)

• Half Life Associated With Terminal Slope (t1/2) of Moxifloxacin and its Metabolites

  Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)

• Total Amount Excreted in the Urine (Aeur) of Moxifloxacin and its Metabolites

  Baseline up to 36 hour post-infusion

• Volume of Distribution at Steady State (Vss) of Moxifloxacin and its Metabolites

  Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)

• Plasma Clearance (CL) of Moxifloxacin and its Metabolites

  Pre-dose, 1 hour (end of infusion), 1.5, 4, 8, 12 and 24 hours (Day 2) after start of infusion (samples at 36 h and 48 h were optional)

Study Arms (3)

Moxifloxacin (Avelox, BAY12-8039), Cohort 1

EXPERIMENTAL

Drug: Moxifloxacin (Avelox, BAY12-8039)

Moxifloxacin (Avelox, BAY12-8039), Cohort 2

EXPERIMENTAL

Drug: Moxifloxacin (Avelox, BAY12-8039)

Moxifloxacin (Avelox, BAY12-8039), Cohort 3

EXPERIMENTAL

Drug: Moxifloxacin (Avelox, BAY12-8039)

Interventions

Moxifloxacin (Avelox, BAY12-8039) 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 1

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females, ages 3 months through 14 years inclusive
• Receiving antibiotics for suspected or proven infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (11)

Unknown Facility

Little Rock, Arkansas, 72202, United States

Location

Unknown Facility

Orange, California, 92868-3974, United States

Location

Unknown Facility

San Diego, California, 92123-4282, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

New Orleans, Louisiana, 70118-5799, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Kansas City, Missouri, 64108-9898, United States

Location

Unknown Facility

Cincinnati, Ohio, 45229-3039, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Toledo, Ohio, 43606, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 29356761 DERIVED

Related Links

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

MeSH Terms

Conditions

Infections

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

US (11)