NCT04677842: EPPICC

European Pregnancy and Paediatric Infections Cohort Collaboration: Paediatric Protocol

Status unknown Last updated 21 December 2020

What this trial tests

trial testing ART Therapy in HIV Infections in 10,000 participants. Status unknown.

Timeline

1 January 2013

Primary endpoint
11 November 2020

1 January 2025

Quick facts

Lead sponsor	PENTA Foundation
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	1 January 2013
Primary completion	11 November 2020
Estimated completion	1 January 2025

Drugs / interventions tested

• ART Therapy — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Tuberculosis Infection — all drugs for Tuberculosis Infection →
• Hepatitis C — all drugs for Hepatitis C →
• Covid19 — all drugs for Covid19 →

Sponsor

PENTA Foundation

Who can join

Under 17, any sex, with HIV Infections or Tuberculosis Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral Suppression, Viral Failure, and Safety Outcomes in Children and Adolescents With HIV on Dolutegravir in Europe and Thailand.
   Scott K, O'Rourke J, Jackson C, Ene L, et al · · 2025 · cited 2× · PMID 40215206 · DOI 10.1093/cid/ciaf191
2. Changes in Body Mass Index in Children and Adolescents Living With Human Immunodeficiency Virus in Europe and Thailand Starting Dolutegravir.
   Epidemiology of Pregnancy and Paediatric Infections International Cohort Collaboration (EPPICC) Study Group . · · 2025 · PMID 41426260 · DOI 10.1093/ofid/ofaf640