check_circleStudy Completed

Infections

Bayer Identifier:

11826

ClinicalTrials.gov Identifier:

NCT01049022

EudraCT Number:

2012-000737-40

EU CT Number:

Not Available
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients

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

Key Participants Requirements

Sex

Both

Age

3 - 14 Years
  • - Males or females, ages 3 months through 14 years inclusive
    - Receiving antibiotics for suspected or proven infection
  • - 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
May 2010 - August 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University Hospitals Case Medical CenterCleveland, 44106, United States
Terminated
Children's Hospital of New OrleansNew Orleans, 70118-5799, United States
Completed
Arkansas Children's HospitalLittle Rock, 72202, United States
Completed
University of LouisvilleLouisville, 40202, United States
Terminated
Children's Hospital BostonBoston, 02115, United States
Terminated
Children's Mercy HospitalKansas City, 64108-9898, United States
Completed
Children's Hospital of Orange CountyOrange, 92868-3974, United States
Completed
Rady Children's Hospital–San DiegoSan Diego, 92123-4282, United States
Completed
Toledo Children's HospitalToledo, 43606, United States
Terminated
University of Utah Medical CenterSalt Lake City, 84132, United States
Terminated
Cincinnati Children's Hospital Medical CenterCincinnati, 45229-3039, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    no
  • 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.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    no
  • 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.
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Day 1 up to Year 5 (follow-up)
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin and its Metabolites
    tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • Half Life Associated With Terminal Slope (t1/2) of Moxifloxacin and its Metabolites
    Half life associated with terminal slope refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in hours (h) and derived from the terminal slope of the concentration versus time curve.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • Total Amount Excreted in the Urine (Aeur) of Moxifloxacin and its Metabolites
    Aeur refers to the total amount of moxifloxacin excreted in urine.
    date_rangeTime Frame:
    Baseline up to 36 hour post-infusion
    enhanced_encryption
    Safety Issue:
    No
  • Volume of Distribution at Steady State (Vss) of Moxifloxacin and its Metabolites
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • Plasma Clearance (CL) of Moxifloxacin and its Metabolites
    Total body clearance of drug in plasma is expressed in litres per hour.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kilogram Body Weight (AUCnorm) of Moxifloxacin and its Metabolites
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCnorm is defined as AUC divided by dose per kg body weight.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Plasma Concentration Divided by Dose Per kilogram Body Weight (Cmax,Norm) 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. Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.
    date_rangeTime Frame:
    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)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
3

Additional Information

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