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临床试验/NCT04812847
NCT04812847已完成不适用

Infecciones Por patógenos Gramnegativos Con Multirresistencia a Drogas en Neonatos de Alto Riesgo en el Noreste de México

Instituto Tecnologico y de Estudios Superiores de Monterey1 个研究点 分布在 1 个国家目标入组 597 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
597
试验地点
1
主要终点
Burden of Gram Negative organisms infections

研究概览

简要总结

The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates from these subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates).

详细描述

The investigators propose a mixed design approach, a cohort´s study with a nested case-control analysis. Study subjects will be the gram-negative isolates at the study hospital clinical laboratory. The cohort´s exposure factor will be the presence or absence of a multidrug resistance gram-negative bacterial isolate.

The prospective cohort will allow the estimation of Gram-negative infection burden in the study population, and the characterization of all microorganisms isolates from study subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates); the cohort will be formed by each neonate, from the admission to special care, the isolation date and then follow-up until the resolution, being it discharge either alive, dead or by transfer to another facility. Risk ratios for each of these outcomes will be calculated.

Cases-controls analysis will allow the research team to identify main risk factors present in those individuals who further had or did not have a gram-negative MDR isolate, by calculation of associated odds ratios for concurrent perinatal factors. Another project goal, to establish correlations and measure risk factors (Odds ratios) between Gram-negative infection with MDR organisms and concurrent illness and treatments offered in the special care nursery (medical [antibiotics, non-steroid anti-inflammatory drugs, steroids, others], surgical, and clinical procedures) in neonates under special care, will also be attained through the nested cases and controls study approach.

Finally, a derivative from this project will be the establishment of the North-East Mexico Regional Repository of bacterial isolates in Neonates under special care. At the first stage, this repository will preserve specimens of bacteria, both Gram-negative and Gram-positive, along with a specially developed anonymous database of the individuals hosting those infections. In the near future, the focus of this repository may expand to fungus, parasites and perhaps viral isolates preservation.

The research team has also proposed an exploratory objective, subject to budget availability, and that is the characterization and comparison of the immuno-phenotype of those individuals affected of Gram-negative infection with MDR resistant organisms, those with infection with other organisms and those not affected by infectious complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 180 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates of either sex, and any gestational age, admitted to the special care nursery of Hospital Regional Materno Infantil (Includes also out-born and transferred babies),
  • Treating physician´s order to draw any biological sample and send it for culture at the hospital´s clinical laboratory.
  • A culture with an isolate of Gram-negative bacteria.

排除标准

  • Any culture negative for bacterial growth
  • Any culture with Gram-positive bacteria, or fungus growth.

结局指标

主要结局

Burden of Gram Negative organisms infections

时间窗: Through study completion, an average of three months

The isolation of a gram-negative organism, from any clinical site, in neonates under clinical care in special care nursery; Incidence = New cases during the study period, Prevalence = Total cases during the study period.

次要结局

  • Odds ratio for the occurrence of Gram-negative MDR infections(Through study completion, an average of three months)
  • Risk factors for the occurrence of Gram-negative MDR infections.(Through study completion, an average of three months)

研究者

发起方
Instituto Tecnologico y de Estudios Superiores de Monterey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victor Javier Lara-Diaz, M.D., Ph.D.

Professor-Researcher

Instituto Tecnologico y de Estudios Superiores de Monterey

研究点 (1)

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