Global Network for Women's and Children's Health Research Data Coordinating Center

全球妇女和儿童健康网络研究数据协调中心

• 批准号: 10474098
• 负责人: Elizabeth M McClure
• 金额: $ 50万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-09 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10474098
• 关键词: 16S ribosomal RNA sequencing; Address; Alabama; Amniotic Fluid; Anaerobic Bacteria; Anterior nares; Antibiotic Resistance; Antibiotic-resistant organism; Antibiotics; Antimicrobial Resistance; Asia; Asthma; Attention; Azithromycin; Bacterial Infections; Benefits and Risks; Biological; Breast Feeding; Budgets; Buffers; Characteristics; Child; Child Health; Chromosome Mapping; Clinical; Clinical Microbiology; Collection; Communicable Diseases; Communities; Consent; Control Groups; Country; DNA; Data; Data Coordinating Center; Data Set; Databases; Detection; Development; Diagnosis; Dose; Drug Kinetics; Dry Ice; Ecosystem; Enrollment; Enzymes; Escherichia coli; Evaluation; Exposure to; Follow-Up Studies; Freezing; Funding; Future; Gambia; Gastrointestinal Diseases; Gene Transfer; Genes; Genital; Genitalia; Genomics; Government; Half-Life; High Prevalence; Hour; Human Milk; Immune; Immune response; India; Infant; Infection; Infection prevention; Inflammatory; Intervention; Intravenous; Label; Length; Low Prevalence; Macrolide-resistance; Macrolides; Massachusetts; Measures; Mediating; Medical; Metagenomics; Methods; Methyltransferase; Microbe; Molecular; Monitor; Mothers; Mycoplasma; Nasopharynx; Neisseria gonorrhoeae; Neonatal; Neurocognitive; Newborn Infant; Niger; Obesity; Opportunistic Infections; Organism; Outcome; Output; Participant; Pathogenicity; Pattern; Perinatal; Phosphorylases; Placebos; Placenta; Plasma; Population; Population Heterogeneity; Postpartum Period; Predisposition; Pregnancy; Prevalence; Procedures; Prophylactic treatment; Protocols documentation; RNA; Randomized; Recombinant DNA; Reporting; Research; Resistance; Resources; Ribosomal RNA; Risk; Safety; Salmonella typhi; Sample Size; Sampling; Sepsis; Shipping; Ships; Shotguns; Site; Specimen; Standardization; Staphylococcus aureus; Statistical Data Interpretation; Streptococcus pneumoniae; Swab; Techniques; Testing; Time; Tissues; Trial of Labor; Umbilical Cord Blood; Universities; Ureaplasma; Visit; Walkers; Woman; Work; aged; antimicrobial; azithromycin resistance; bacterial resistance; bacteriome; base; cost; dysbiosis; efflux pump; esterase; follow-up; group intervention; host microbiome; infant gut microbiome; infant infection; insight; intervention cost; intrapartum; metagenomic sequencing; microbial; microbial community; microbiome; microbiome analysis; microbiome research; mortality; nasopharyngeal swab; neonate; nursing mothers; pathogen; pathogenic bacteria; placebo group; placental transfer; prophylactic; rRNA Genes; rectal; research clinical testing; resistance gene; sample collection; time use; transmission process; treatment arm; uptake

Supplement for the Global Network for Women’s and Children’s Health Research’s A-PLUS Antimicrobial Resistance Study Project Summary The Global Network is currently undertaking a trial of azithromycin to reduce risk of sepsis and newborns (A-PLUS). An important question to understand is the prevalence of antimicrobial resistance among women exposed to azithromycin. Thus, this supplement will be used to support the ongoing serial collection of clinical specimens from mothers and infants, and testing of these specimens for Azithromycin-resistant bacteria by culture to 3 months for all dyads (regardless of resistance at 6 weeks) and a final sample collection between 6 and 12 months post-partum for culture of maternal and infant samples (Nasopharyngeal [NP]and rectal) to also test for Azithromycin-resistant bacteria by culture. Samples from all timepoints will be used to assess the maternal and infant microbiome and to assess the effects of the single dose of prophylactic azithromycin on the resistome by identifying and determining the duration of any potential dysbiosis and presence of resistance genes in the microbial communities. Specifically, supplemental funds to the data coordinating center will support the activities of the sub-study outlined below: * Facilitating sample collection, testing for anti-microbial resistance for 3 month duration followed by final sample collection at 6 and 12 months post-partum in sub-set of mother -infant dyads * Procuring and shipping supplies for NP swabs and rectal swabs to the 8 Global Network Sites. * Providing labels, tracking and analyses of participant’s enrolled in the sub-study. * Managing the shipments of samples from the 8 sites to UAB for analyses, including: o shipping NP swabs and rectal swab specimens in stabilizing buffer on dry ice from the 8 Global Network Sites to the University of Alabama at Birmingham. o shipping bacterial isolates from routine clinical cultures on dry ice from the 8 Global Network Sites to University of Alabama at Birmingham. * Statistical data analyses of the associations with outcomes to the microbiome and resistome analyses. * maintaining the database with the participant characteristics and outcomes and make these data available for public use, as indicated. In summary, the proposed work will address the global concerns about use of azithromycin in laboring women with a comprehensive evaluation of the risk of azithromycin resistance and the changes in maternal-neonatal microbiome and resistome over time and across the diverse populations enrolled in the Global Network Trial. Without the supplemental funds and the above new studies, we will not be able to optimally determine the extent and duration of risk of antimicrobial resistance patterns in this large multi-country study of women and children who were exposed to azithromycin which may be beneficial in preventing infection/mortality and also be neuroprotective for the children. Furthermore, we will otherwise not be able to complete any of the microbiome studies on stored specimens and will not be able to conduct resistome studies which will provide molecular insights into AMR patterns and thereby provide a more complete picture of the effects of our promising intervention on the AMR and microbiome. Because of the large sample size, multi-country sites, and high quality to detail, this proposal has a unique opportunity to thoroughly answer the question of safety in this simple, low-cost intervention.

补充全球妇女和儿童健康研究网络的A-Plus 抗菌耐药性研究 项目摘要 全球网络目前正在对阿奇霉素进行试验，以降低败血症的风险 新生儿（A-Plus）。一个要理解的重要问题是抗菌抗性的流行率 在暴露于阿奇霉素的妇女中。这是该补充剂将用于支持正在进行的 来自母亲和婴儿的临床标本的系列收集，以及这些标本的测试 所有二元组培养至3个月抗霉素的抗性细菌（不管6周的耐药性如何） 以及在产后6到12个月之间的最终样本收集，用于母子和婴儿的培养物 样品（鼻咽[NP]和直肠）也通过培养物测试抗霉素抗性细菌。 来自所有时间点的样本将用于评估母体和婴儿微生物组并评估 通过识别和确定，单剂量的预防性阿奇霉素对抵抗组的影响 微生物群落中任何潜在的营养不良和耐药基因的存在的持续时间。 具体而言，数据协调中心的补充资金将支持以下概述的子研究活动： *促进样品收集，持续3个月的抗微生物抗性测试 通过最终样本收集在儿童二元组的子集中6和12个月的样本收集 *为NP拭子和直肠拭子采购和运输供应到8个全球网站。 *提供参与者参加子学的标签，跟踪和分析。 *管理从8个站点到UAB的样品运输以进行分析，包括： o运输NP拭子和直肠拭子标本，以稳定8号的干冰缓冲液 伯明翰阿拉巴马大学的全球网络站点。 o从8个全球干冰上的常规临床培养物中的运输细菌分离株 伯明翰阿拉巴马大学的网站。 *与微生物组和树脂组结果的关联的统计数据分析 分析。 *通过参与特征和结果维护数据库，并制作这些数据库 如所示，可用于公共使用的数据。 总而言之，拟议的工作将解决全球对使用阿奇霉素劳动的关注 对阿奇霉素抗性风险进行全面评估的妇女 随着时间的流逝以及参与的潜水员种群 全球网络试验。没有补充资金和上述新研究，我们将不会 可以最佳地确定抗菌抗性模式的风险程度和持续时间 大型多国研究暴露于阿奇霉素的妇女和儿童可能是 有益于预防感染/死亡率，也对儿童具有神经保护作用。此外， 否则，我们将无法完成对存储标本的任何微生物组研究，并且将 无法进行抵抗组研究，这将提供分子见解，以了解AMR模式和 因此，更完整地了解了我们承诺的干预对AMR的影响 微生物组。由于样本量较大，多国站点和高质量的细节，因此 提案有一个独特的机会，可以在这个简单的低成本中彻底回答安全问题 干涉。