EUCTR2012-000737-40-Outside-EU/EEA进行中（未招募）不适用
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The informed consent must be signed before any study specific tests or procedures are done
- •Males or females, ages 3 months through 14 years inclusive
- •Receiving antibiotics for suspected or proven infection
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 >1.5 or ALT > 3 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 days(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
研究者
相似试验
暂停
1 期
A study in healthy Japanese men to test how different doses of BI 894416 are toleratedJPRN-jRCT2080225328ippon Boehringer Ingelheim Co., Ltd.24
招募中
1 期
A study in healthy Japanese men to test how well different dosesof BI 1569912 are toleratedMajor Dipressive DisorderJPRN-jRCT2071210037Furuichi Takumi44
尚未招募
1 期
A study in healthy Japanese men to test how well different doses of BI 764198 are toleratedAJPRN-jRCT2071200055Ogawa Shintaro44
已完成
1 期
A study in healthy Japanese men to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the bloodJPRN-jRCT2071200056Katakabe Tetsuya74
进行中（未招募）
1 期
A study to test different doses of BI 836880 in patients with an eye disease called wet age-related macular degeneration (wAMD)wet age-related macular degeneration (wAMD)MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: LLTClassification code 10075718Term: Exudative age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2017-001221-40-DEBoehringer Ingelheim Pharma GmbH & Co. KG42