EUCTR2015-002778-19-Outside-EU/EEA进行中（未招募）不适用
An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens
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
- 389
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
- •Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care
- •Written participant assent (as appropriate)
- •Male or female between the ages of 1 and 17 years old, inclusive
- •If female of childbearing potential (defined as post-menarche), not lactating or pregnant, documented negative pregnancy test result within 48 hours prior to study medication administration and willing to practice reliable birth control measures (at the discretion of the Principal Investigator) during study treatment and for at least 28 days after study completion
- •Able to comply with the protocol for the duration of the study
- •Skin and skin structure infections of a complicated nature known or suspected to be caused by Gram-positive pathogen(s) that require IV antibiotic treatment. Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (such as, infected ulcers, burns, and major abscesses) or infections in which the participant has a significant underlying disease state that complicates the response to treatment. The Investigator may contact the Medical Monitor to discuss infections not meeting this definition but which otherwise appear appropriate for inclusion
- •At least three of the following clinical signs and symptoms associated with the cSSSI: pain; tenderness to palpation; temperature >37.5 degrees Celsius (C) (99.5 degrees Fahrenheit [F]) oral or >38 degrees C (100.4 degrees F) rectal; white blood count (WBC) >12,000/cubic millimeter (mm^3) or =10% bands; swelling and/or induration; erythema (>1 centimeter [cm] beyond edge of wound or abscess); or pus formation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 389
- •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
- •Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry
- •Known allergy/hypersensitivity to daptomycin
- •Known infection caused solely by Gram-negative pathogen(s), fungus(i), or virus(es)
- •Previous systemic antimicrobial therapy exceeding 24 hours in duration administered anytime during the 48 hours prior to the first dose of study drug (exception: a participant is eligible if on previous antibiotics without any clinical improvement and/or a wound culture is available and the pathogen is not sensitive to prior therapy)
- •Known or suspected pneumonia, osteomyelitis, meningitis, or endocarditis
- •Known bacteremia (exception: any participant enrolled in the study that is subsequently found to have a blood culture positive for bacteremia may be continued)
- •Participant with current or known clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]) that would expose the participant to unacceptable risk as determined by Investigator
- •History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological, autoimmune disease, or primary immune deficiency (unless the Investigator considers that the subject would not be at risk by participating in the study [Note: human immunodeficiency virus-infected participants must not be enrolled])
- •History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system, or seizure disorder
- •Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre syndrome or spinal cord injury
- •Known or suspected renal insufficiency (that is, estimated creatinine clearance rate [CLcr]<80 mL/min/1.73 squared meter [m^2]
- •History of or current rhabdomyolysis
- •History of (within 1 year prior to first dose of study drug) or current myositis
- •Current septic shock
- •Known or suspected creatine phosphokinase (CPK) elevation
研究者
相似试验
未知
不适用
A-L03-L088 Other specified local infections of skin and subcutaneous tissue-L02Other specified local infections of skin and subcutaneous tissueL02L03L088PER-006-13Cubist Pharmaceuticals, Inc,
招募中
2 期
A Phase II Study of FYU-981 in Hyperuricemic Pediatric Patients with or without GoutHyperuricemic pediatric patients with or without goutJPRN-jRCT2031220036Masahiko Fushimi30
招募中
4 期
To evaluate the efficacy, safety and pharmacoeconomics of Shiwei Longdanhua capsule in the treatment of acute tracheo-bronchitis (phlegm-heat obstructing lung syndrome)Acute tracheobronchitisITMCTR2200006863The Second Affiliated Hospital of Tianjin University of Chinese Medicine
已完成
不适用
Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Harvest Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic UlcersISRCTN28965380Harvest Technologies Corp. (USA)59
进行中（未招募）
不适用
Clinical Evaluation of the AqueSys Implant for the Treatment of ocular hypertension and open angle glaucomaOcular hypertension and open angle glaucomaEye - Diseases / disorders of the eyeACTRN12610000021077Aquesys Inc20