European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC): Paediatric Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,000
- 主要终点
- CD4 count in adulthood of young people with HIV assessed using routine clinical data
研究概览
简要总结
Across Europe and worldwide, there are many studies following groups (cohorts) of children living with human immunodeficiency virus (HIV) and other infections over time, to monitor their long-term health. Some of these infections are rare: for example, few children in Western Europe are living with HIV, so the studies often have fairly small numbers of participants. This can make it difficult to answer research questions in these cohorts and means that doctors and researchers working with these patients in different countries need to work together. This is particularly important as children are not often included in clinical trials of treatments and other interventions.
The European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) is an international network of researchers working together in this way. Researchers in the network represent cohort studies of pregnant women and children with, or at risk of, infections from across Europe and Thailand. The research focuses on infections in pregnant women and children, particularly HIV, hepatitis B and C virus, and tuberculosis, and, from 2020, novel coronavirus (COVID-19). By combining data from many cohorts, the researchers aim to answer questions that could not be answered by one study individually (for example, because a large number of pregnant women or children are needed to answer the question).
This protocol focuses on the paediatric component of EPPICC's research, which focuses on the treatment of children at risk of and living with infections. For example, what medicines are used most often and how do they affect children's health? EPPICC is an observational study, which means that children do not receive any extra treatment as part of the study. Instead, children are "observed" during their routine medical care. Each cohort keeps records of the children's health collected at routine clinic visits, including information such as date of birth and sex, results of diagnostic tests, treatments received, and any illnesses or other events that the children have had. The EPPICC study combines and analyses data from all of the cohorts that take part, to answer questions about the risks and benefits of different diagnosis or treatment strategies, the long-term effects of infection and treatment during childhood and young adulthood, and regional variations (e.g. between Western and Eastern Europe) in the risk and management of infections.
All of the data collected through the EPPICC Paediatric Protocol are stored securely at the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. Data collection and storage are governed by the General Data Protection Regulation. A Steering Committee guides the research to make sure it is relevant and of high quality. Public and patient involvement (PPI) may be provided by individual cohorts' own groups, as well as by the interlinked Penta organisation, which is a network of paediatricians and researchers working in infections in Europe and globally. The PPI groups help with release of the results of the research. The results are also published on the Penta Foundation's public website (https://penta-id.org/), and presented at conferences and published in Open Access scientific journals.
详细描述
MAIN AIM OF THE STUDY The overall aim of the EPPICC Paediatric Protocol is to analyse individual patient data from across collaborating European and international cohorts on infections in children and young people, to inform optimal prevention and treatment strategies.
MAIN AREAS OF FOCUS HIV: prevalence and incidence of immunological and virological failure, HIV resistance, AIDS and non-AIDS events, mortality, cascade of care, engagement in care (including after transfer to adult care); antiretroviral therapy status and toxicities (adverse events, serious adverse events and discontinuation of drug) HCV: disease progression, uptake and outcome (effectiveness and safety) of HCV treatment in HCV mono- and HCV-HIV co-infected patients TB: incidence (including exploration of different diagnostic/screening strategies across regions) of LTBI and TB disease; outcomes of TB treatment including treatment of LTBI COVID-19: prevalence and incidence of infection and disease among both the general population and specifically among children and adolescents living with HIV; admission to hospital/ICU; outcomes (including resolution, death, sequelae (e.g. paediatric inflammatory syndrome temporally associated with SARS-CoV-2)) COHORT / INVESTIGATOR INCLUSION CRITERIA The study Sponsor has overall responsibility for site and investigator selection.
The Principal Investigators of cohorts which have participated in previous EPPICC data mergers will be approached to ascertain their interest in participating in future data mergers. New cohorts may also be identified and may be invited to participate. The key inclusion criterion for a cohort to participate is enrolment of children and adolescents with the infection of interest. All cohorts who are able to commit to submitting and cleaning data, obtaining any ethical, regulatory or other approvals required locally, and completion of data sharing agreements in accordance with the project timelines will be included.
DATA COLLECTION Collected data are pseudonymised: no names, initials, hospital numbers, national ID or addresses of patients are collected. Core data items included in most EPPICC paediatric data mergers include the following; Demographic: Date of birth, sex, ethnicity/country of origin, country of residence Therapeutic: Prophylaxis and treatment data (HIV, HCV, TB and COVID-19 treatments) including start and stop dates, drug names, doses and frequency of administration, and reasons for change/discontinuation Diagnostic: Diagnostic tests for infections undertaken, including dates and results Concurrent treatments: Other medications Clinical Infection status: (HIV, TB, HCV, HBV, SARS-CoV-2, other infection of interest), mode of acquisition of infection, date of diagnosis, disease stage Clinical (other events): Adverse events (e.g. severity, causal relation to drugs), AIDS- and non-AIDS- defining malignancies, COVID-19 sequelae, weight, height, death, causes of death, pregnancy, hospitalisations Laboratory: Absolute CD4 counts and percentage, HIV RNA, HCV RNA measurements, other lab markers Other Follow-up status, reason for study drop-out, transfer to adult care
For certain analyses, additional data items may be requested, and may include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
CD4 count in adulthood of young people with HIV assessed using routine clinical data
时间窗: through study completion, an average of 5 year
CD4 change from drug start up to 144 weeks
时间窗: up to 144 weeks
Cumulative incidence of virological failure (>1000 copies/mL)
时间窗: through study completion, an average of 5 years
Viral suppression defined as <50 copies, <400 copies and 1000 copies/mL) upto 144 weeks.
时间窗: up to 144 weeks
From start of novel drug of interest through to earliest date of the following: death, loss to follow-up, discontinuation of drug or last visit
时间窗: From date of novel drug initiation until earliest date of death, loss to follow-up, discontinuation of drug or last visit assessed up to 36 months
2. Viral suppression in adulthood of young people with HIV assessed using routine clinical data
时间窗: through study completion, an average of 5 year
次要结局
未报告次要终点