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

基本信息

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
项目类别：
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

项目摘要

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.

全球妇女和儿童健康研究网络 A-PLUS 增刊抗菌素耐药性研究项目概要全球网络目前正在进行一项阿奇霉素试验，以降低败血症和新生儿 (A-PLUS) 需要了解的一个重要问题是抗菌药物耐药性的普遍程度。因此，该补充剂将用于支持正在进行的治疗。连续采集母亲和婴儿的临床样本，并对这些样本进行检测所有二联体培养至 3 个月时出现阿奇霉素耐药细菌（无论 6 周时的耐药情况如何）产后 6 至 12 个月内采集最终样本，用于母婴培养样本（鼻咽 [NP] 和直肠）还可以通过培养检测阿奇霉素耐药细菌。所有时间点的样本将用于评估母婴微生物组并评估通过识别和测定单剂量预防性阿奇霉素对耐药组的影响微生物群落中任何潜在生态失调和抗性基因存在的持续时间。具体来说，数据协调中心的补充资金将支持下述子研究的活动： * 促进样本采集，随后进行为期 3 个月的抗菌耐药性测试根据产后 6 个月和 12 个月母婴二人子组的最终样本采集 * 采购 NP 拭子和直肠拭子用品并将其运送到 8 个全球网络站点。 * 提供子研究参与者的标签、跟踪和分析。 * 管理从 8 个地点到 UAB 进行分析的样品运输，包括： o 将 NP 拭子和直肠拭子样本放在干冰上的稳定缓冲液中从 8 运输阿拉巴马大学伯明翰分校的全球网站。 o 使用干冰从 8 全球运输常规临床培养物中分离的细菌阿拉巴马大学伯明翰分校的网站。 * 与微生物组和耐药组结果关联的统计数据分析分析。 * 维护参与者特征和结果的数据库，并使这些如所示，可供公众使用的数据。总之，拟议的工作将解决全球对在分娩中使用阿奇霉素的担忧综合评估女性阿奇霉素耐药风险及变化随着时间的推移以及参与研究的不同人群的孕产妇-新生儿微生物组和耐药组如果没有补充资金和上述新研究，我们就不会进行全球网络试验。能够最佳地确定该领域抗菌素耐药性模式风险的程度和持续时间对接触阿奇霉素的妇女和儿童进行的大型多国研究可能有益于预防感染/死亡，并且还可以保护儿童的神经。否则我们将无法完成对储存样本的任何微生物组研究，并将无法进行抗药性研究，这将提供对 AMR 模式的分子见解，更全面地了解我们有希望的干预措施对抗菌素耐药性的影响，从而由于样本量大、地点多、细节质量高，这使得微生物组成为可能。该提案有一个独特的机会以这种简单、低成本的方式彻底回答安全问题干涉。