MULTIPLE DOSE PHARMACOKINETIC STUDY OF MEROPENEM IN YOUNG INFANTS (<91 DAYS)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 美罗培南是一种碳青霉烯类抗生素，具有现有的最广泛的抗微生物活性，包括大多数导致幼儿(91天)发生的严重、危及生命的感染的细菌病原体。美罗培南对大多数超广谱β-内酰胺酶和AmpC染色体β-内酰胺酶的水解稳定，突显了药物S对许多耐药革兰氏阳性菌(如耐青霉素肺炎链球菌)和革兰氏阴性菌(如铜绿假单胞菌)的活性。 美罗培南的重要适应症包括多重耐药病原体和多菌败血症引起的感染。美罗培南是FDA标记的，适用于从三个月大到青春期的儿科受试者，作为细菌性脑膜炎和复杂的腹内感染的单药抗菌疗法。美罗培南在新生儿和三个月以下的婴儿中有大量的标签外使用。尽管缺乏针对这一脆弱受试者群体的足够的美罗培南PK、剂量、耐受性和安全性数据，这种标签外使用仍会发生。本提案旨在确定美罗培南用于治疗疑似和复杂的新生儿和小于3个月的婴儿的腹内感染的PK和安全性。 美罗培南将是一种安全和可耐受的治疗方法，用于治疗91天以下婴儿的疑似或有记录的复杂性腹内感染。 美罗培南(MPods)的多中心前瞻性剂量递增PK研究： 这项研究将评估美罗培南在91天大的疑似和复杂的腹内感染婴儿中的安全性、耐受性和PK-PD。 这项试验的具体目的是： 1.美罗培南单剂和多剂PK在疑似和疑似腹内感染患者中的应用特征 2.评价美罗培南治疗疑似及疑似腹内感染的安全性。 3.评估收集的美罗培南治疗疑似和复杂的腹内感染的疗效数据。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Meropenem, a carbapenem, belongs to an antibiotic class that possesses one of the broadest spectra of antimicrobial activity available, including most of the bacterial pathogens responsible for serious, life-threatening infections occurring in young (<91 days) infants. Meropenem is stable against hydrolysis by most extended spectrum beta-lactamases and AmpC chromosomal beta-lactamases underscoring the drug s activity against many antibiotic resistant Gram positive (e.g., penicillin-resistant S. pneumoniae) and Gram negative (e.g., P. aeruginosa) bacteria. Important indications for meropenem involve infections due to multi-drug resistant pathogens and polymicrobial sepsis. Meropenem is FDA-labeled for pediatric subjects from three months of age through adolescence as single agent antimicrobial therapy for bacterial meningitis and complicated intra-abdominal infections. There is substantial off-label use of meropenem in neonates and infants younger than three months of age. This off-label use occurs despite the lack of adequate meropenem PK, dosing, tolerability and safety data for this vulnerable subject group. The present proposal aims to determine PK and safety of meropenem for the treatment of suspected and complicated intra-abdominal in neonates and infants younger than three months of age. Meropenem will be a safe and tolerable treatment of suspected or documented complicated intra-abdominal infections in infants less than 91 days of age. Multicenter, Prospective, Dose Escalating PK Study of Meropenem (MPODS): This study will evaluate the safety, tolerability and PK-PD of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections. The specific aims of this trial are: 1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections. 2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections. 3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.