PK Analysis in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Trimethoprim-Sulfamethoxazole

PK Analysis Data
Study Description
Aim: Characterize the pharmacokinetics (PK) of enteral TMP and SMX administered to children per standard of care (SOC) as prescribed by their treating caregiver.

Methods: The PK analyses include plasma TMP-SMX data following enteral administration from NICHD-2011-POP01, a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who received drugs per SOC, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including TMP-SMX, and is actively enrolling participants for other DOIs.

Results: A one-compartment model with first-order absorption and elimination described the PK data for both TMP and SMX. No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to TMP-SMX were reported. Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver; who provided consent/assent and were not pregnant were enrolled. 188 enrolled, and 153 were in the PK population.

药代动力学（Pharmacokinetics，PK）分析数据集
研究概况
研究目的：明确按照治疗医师处方的标准治疗方案（Standard of Care，SOC）给予儿童肠内给药甲氧苄啶（Trimethoprim，TMP）与磺胺甲噁唑（Sulfamethoxazole，SMX）的药代动力学特征。
研究方法：本次药代动力学分析纳入了来自NICHD-2011-POP01研究的肠内给药后血浆TMP-SMX检测数据。该研究为多中心前瞻性机会性药代动力学研究，针对21岁以下、遵循治疗医师处方按标准治疗方案给药的儿童群体，对尚未被充分研究的药物开展研究。NICHD-2011-POP01研究目前已纳入包括TMP-SMX在内的多种目标研究药物（Drug of Interest，DOI）队列，且仍在积极招募其他目标研究药物的受试者。
研究结果：采用一级吸收与消除的单房室模型，可良好拟合TMP与SMX的药代动力学数据。本研究未报告与研究流程相关的不良事件（Adverse Event，AE）或严重不良事件（Serious Adverse Event，SAE），亦未报告与TMP-SMX相关的严重、意外、疑似不良反应。本研究纳入标准为：21岁以下、按照治疗医师处方接受标准治疗方案给药且使用尚未被充分研究的目标研究药物、已签署知情同意/儿童同意书且未妊娠的儿童。本次研究共招募188名受试者，其中153名被纳入药代动力学分析人群。