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临床试验/NCT02868541
NCT02868541已完成不适用

Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 905 人开始时间: 2017年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
905
试验地点
1
主要终点
The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj

研究概览

简要总结

The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management.

This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All travelers presenting during the study period in the service of international vaccination for mandatory meningococcal ACYW135 vaccination ,
  • Affiliated to a social security insurance regime
  • Male or Female
  • Aged over 18 years
  • Having signed informed consent form
  • able to understand and answer the study questions
  • Exclusion Criteria
  • Patients aged under 18
  • Patient whose protocol compliance seems unlikely to investigator
  • Participant in another clinical trial or in exclusion period of a previous clinical trial,
  • Unable to understand the nature and objectives of the study,
  • Refusing to sign the informed consent form.

排除标准

  • 未提供

结局指标

主要结局

The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj

时间窗: up to 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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