Clinical trial NCT01049022: Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
Official title: Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections
Keywords: Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Area under the Concentration-Time Curve (AUC) of Moxifloxacin and its Metabolites
timeFrame: 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)
measure: Maximum Observed Drug Concentration in Plasma (Cmax) of Moxifloxacin and its Metabolites
timeFrame: 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)
measure: Number of Subjects With Treatment Emergent Findings on Joint Assessment: Baseline
timeFrame: Baseline
measure: Number of Subjects With Treatment Emergent Findings on Joint Assessment : At any Time During Treatment
timeFrame: Day 1 up to Year 5 (follow-up)
Secondary outcomes:
measure: Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin and its Metabolites
timeFrame: 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)
measure: Half Life Associated With Terminal Slope (t1/2) of Moxifloxacin and its Metabolites
timeFrame: 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)
measure: Total Amount Excreted in the Urine (Aeur) of Moxifloxacin and its Metabolites
timeFrame: Baseline up to 36 hour post-infusion
measure: Volume of Distribution at Steady State (Vss) of Moxifloxacin and its Metabolites
timeFrame: 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)
measure: Plasma Clearance (CL) of Moxifloxacin and its Metabolites
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Maximum Observed Plasma Concentration Divided by Dose Per kilogram Body Weight (Cmax,Norm) of Moxifloxacin and its Metabolites
timeFrame: 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)
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.