CTRI/2009/091/000725已完成4 期
Study DAP-PEDS-07-03: An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Seven to Seventeen Years with Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 subject assent (as appropriate);
- •Male or female between the ages of 7 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 intravenous antibiotic treatment. Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (e.g. infected ulcers, burns, and major abscesses) or infections in which the subject 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 C (99.5 degrees F) oral or >38 degrees C (100.4 degrees F) rectal; white blood count (WBC) >12,000/mm3 or ≥10% bands; swelling and/or induration;erythema (>1 cm beyond edge of wound or abscess); pus formation
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 duration administered anytime during the 48 hours prior to the first dose of study drug (exception: a subject 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 subject enrolled in the study that is subsequently found to have a blood culture positive for bacteremia may be continued as described in section 10.4.4);
- •Subjects with current or known clinically significant abnormal laboratory test results (including ECGs) that would expose the subject 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: HIV infected subjects 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 or spinal cord injury;
- •Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection through TOC/Safety visit;
- •Suspected or known renal insufficiency;
- •History of or current rhabdomyolysis;
- •History of (within one year prior to first dose of study drug) or current myositis;
- •Current septic shock;
- •Known or suspected CPK elevation
研究者
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