check_circleStudy Completed
Infections
Bayer Identifier:
11826
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
3 - 14 YearsTrial summary
Enrollment Goal
31Trial Dates
May 2010 - August 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | University Hospitals Case Medical Center | Cleveland, 44106, United States |
Terminated | Children's Hospital of New Orleans | New Orleans, 70118-5799, United States |
Completed | Arkansas Children's Hospital | Little Rock, 72202, United States |
Completed | University of Louisville | Louisville, 40202, United States |
Terminated | Children's Hospital Boston | Boston, 02115, United States |
Terminated | Children's Mercy Hospital | Kansas City, 64108-9898, United States |
Completed | Children's Hospital of Orange County | Orange, 92868-3974, United States |
Completed | Rady Children's Hospital–San Diego | San Diego, 92123-4282, United States |
Completed | Toledo Children's Hospital | Toledo, 43606, United States |
Terminated | University of Utah Medical Center | Salt Lake City, 84132, United States |
Terminated | Cincinnati Children's Hospital Medical Center | Cincinnati, 45229-3039, United States |
Primary Outcome
- Area under the Concentration-Time Curve (AUC) of Moxifloxacin and its MetabolitesThe 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_encryptionnoSafety Issue:
- Maximum Observed Drug Concentration in Plasma (Cmax) of Moxifloxacin and its MetabolitesCmax 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_encryptionnoSafety Issue:
- Number of Subjects With Treatment Emergent Findings on Joint Assessment: BaselineJoint 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:Baselineenhanced_encryptionYesSafety Issue:
- Number of Subjects With Treatment Emergent Findings on Joint Assessment : At any Time During TreatmentJoint 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_encryptionYesSafety Issue:
Secondary Outcome
- Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin and its Metabolitestmax 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_encryptionNoSafety Issue:
- Half Life Associated With Terminal Slope (t1/2) of Moxifloxacin and its MetabolitesHalf 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_encryptionNoSafety Issue:
- Total Amount Excreted in the Urine (Aeur) of Moxifloxacin and its MetabolitesAeur refers to the total amount of moxifloxacin excreted in urine.date_rangeTime Frame:Baseline up to 36 hour post-infusionenhanced_encryptionNoSafety Issue:
- Volume of Distribution at Steady State (Vss) of Moxifloxacin and its MetabolitesVolume 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_encryptionNoSafety Issue:
- Plasma Clearance (CL) of Moxifloxacin and its MetabolitesTotal 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_encryptionNoSafety Issue:
- Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kilogram Body Weight (AUCnorm) of Moxifloxacin and its MetabolitesAUC 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_encryptionNoSafety Issue:
- Maximum Observed Plasma Concentration Divided by Dose Per kilogram Body Weight (Cmax,Norm) of Moxifloxacin and its MetabolitesCmax 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_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
3Additional Information
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