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临床试验/NCT07150871
NCT07150871进行中(未招募)不适用

Impact of the COVID-19 Pandemic on Syphilis: Epidemiological Changes and Interaction With HIV

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
240
试验地点
1
主要终点
Trend of syphilis

研究概览

简要总结

Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV transmission. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022.

详细描述

Syphilis is a chronic infectious disease with a prolonged course, characterized by considerable clinical variability, so much so that it is referred to as the great imitator, due to its ability to manifest itself with symptoms that can mimic numerous other diseases. The clinical picture develops through alternating phases of activity, with obvious symptomatic manifestations, and latency, in which the infection remains silent in the body. It is a globally widespread infection, transmitted mainly through sexual contact, although it can also be transmitted congenitally or through direct contact with infected lesions. The relationship between syphilis and HIV is of growing clinical importance due to increasing rates of co-infection and the particular interaction between these two STIs. Syphilis facilitates the transmission and acquisition of HIV, while HIV infection accelerates the natural progression of syphilis. In addition, HIV has been associated with false positive and false negative results in serological tests for syphilis, complicating the diagnosis and management of the disease. A study conducted by the Department of Medicine in Toronto and the Ministry of Health showed that, in individuals with latent syphilis, the prevalence of HIV remained stable between 1991 and 2012, but increased approximately fivefold from 2012 to 2020, reaching a peak of 52.6%. In 2022, the Ministry of Health reported that syphilis cases had doubled compared to 2018, with incidence rising from 2.5 to 4.3 cases per 100,000 inhabitants. Gonorrhea increased from 1.5 to 3.3 cases per 100,000 inhabitants during the same period. Chlamydia, although less documented than in other European countries, also showed an upward trend, with 1,396 cases per 100,000 inhabitants in 2022. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022. A study published in BMJ Open in 2021 analyzed the impact of the pandemic on healthcare services compared to previous years. The systematic review highlighted a 37% reduction in access to care, with decreases of 42% for outpatient visits, 28% for hospitalizations, 31% for diagnostics, and 30% for therapies. The pandemic has therefore significantly reduced the use of healthcare services, with a greater impact on people with non-serious conditions.

研究设计

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

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

  • Patients aged ≥18 years
  • Patients with microbiological and/or clinical diagnosis of syphilis
  • Patients treated by the Infectious Diseases Department of the University Hospital of Alessandria
  • Signature of informed consent form

排除标准

  • Patients for whom the data required for the study are not available in medical records or electronic filing systems

结局指标

主要结局

Trend of syphilis

时间窗: Baseline

Analyze the trend of syphilis before and after the COVID-19 pandemic

次要结局

  • Characteristics of affected patients(Baseline)
  • Interaction between syphilis and HIV(Baseline)
  • Infection Recurrence Rate(Baseline)

研究者

发起方
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
申办方类型
Other
责任方
Sponsor

研究点 (1)

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