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Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection (ChikVIH)

2016年7月25日 更新者:University Hospital Center of Martinique

Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak.

During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. The most active period was three months.

In this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.

As the chikungunya virus had never circulated in the Caribbean, determining the seroconversion rate can be achieved by realizing a seroprevalence survey among the general population at the end of the outbreak. Another simple method is to estimate the rate in a cohort of patients followed regularly and whose habitat is distributed throughout the territory studied.

The follow up of patients infected by the human immunodeficiency virus (HIV) in the French West Indies is almost exclusively performed in hospitals in department of Infectious and Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected patients on all of our territories, allow to hypothesize that the risk of transmission of arboviruses by exposure to mosquito bites is comparable to the general population. This patient cohort is well suited to study the emergence of Chikungunya in the French West Indie .

Primary objective :

To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the French West Indies by estimating the prevalence of specific antibodies of chikungunya virus in a sample (randomly constituted) from patients infected by HIV and representative of the general population of Martinique and Guadeloupe

Secondary objective :

To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population To estimate the frequency of chronic forms of chikungunya in the studied population

研究概览

研究类型

观察性的

注册 (实际的)

388

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guadeloupe
      • Pointe-à-Pitre、Guadeloupe、法国、97159
        • CHU de Guadeloupe
    • Martinique
      • Fort-de-France、Martinique、法国、97200
        • Centre Hospitalier Universitaire de Fort-de-France

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

patient followed for HIV infection at the 2 investigator centers.

描述

Inclusion Criteria:

  • Adult (> 18 years old)
  • Followed for HIV infection at the 2 investigators centers (1 located at Martinique and 1 at Guadeloupe)
  • resident in Martinique /Guadeloupe ( French West Indies)
  • informed consent signed by the patient

Exclusion Criteria:

  • patient who lived more than 6 month in an risk area for chikungunya virus infection
  • patient with or documented chronic rheumatism
  • patient who has received a blood transfusion during year 2013 or patient who is supposed to receive a blood transfusion during the study
  • patient who has planned to live outside French West Indies during the follow up period

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Enrolled patients
Patient randomly enrolled in the study within a cohort of patient followed for HIV infection.
A blood sample is collected during a follow up visit for HIV infection.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Presence or not of chikungunya virus-specific immunoglobulin G antibodies (Elisa test)
大体时间:1 day
Presence or not of chikungunya virus-specific immunoglobulin G antibodies
1 day

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Pain
大体时间:6 , 12 , 18 months after the first symptoms of chikungunya virus infection
Score range from 0 (No pain) to 10 (worst possible pain)
6 , 12 , 18 months after the first symptoms of chikungunya virus infection

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2015年9月14日

首先提交符合 QC 标准的

2015年9月16日

首次发布 (估计)

2015年9月17日

研究记录更新

最后更新发布 (估计)

2016年7月26日

上次提交的符合 QC 标准的更新

2016年7月25日

最后验证

2016年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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