Edinburgh & Lothian Virus Intervention Study in Kids

Status Completed

Clinical Trial Summary

ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of Hypertonic Saline (HS) nose drops (~2.6% NaCl) vs. standard care in children <7 years of age with symptoms of an Upper Respiratory Tract Infection (URTI).

Clinical Trial Description

The study will run over ~30 months. Children are recruited prior to, or within 48 hours of developing URTI symptoms by advertising in areas such as local schools, nurseries, health centres and workplaces as well as social media. For the purposes of this study an URTI is defined as: at least two respiratory symptoms (nasal stuffiness, runny nose, cough, sore throat, or sneezing) OR one respiratory symptoms and at least one systemic symptom (lethargy, muscle pain, headache, pyrexia ≥38°C). Willing parents/guardians, of children <7 years of age, will be directed by the study advertising to contact the research team at their local research site if they are interested in participating. Children will be randomised to either a Control arm of standard symptomatic care, or an Intervention arm of 3 drops each nostril of HS at least 4 times a day until 24 hours after asymptomatic or maximum of 28 days. All participants will be requested to obtain a mid-turbinate nasal swab prior to first nasal HS drops (repeated daily for 5 days), a daily symptom diary (CARIFS, a valid illness measure in the UK), and an end of illness questionnaire (healthcare use, adverse events, acceptability, infection in household contacts, parental time taken off usual activities). Parent/guardian of the children allocated to the intervention arm will be taught how to prepare the HS. Parent/guardian of children who are asymptomatic at recruitment are requested to inform CCRF when the child develops an URTI (within 48 hours) and follow the instructions already provided to them when given the go-ahead to start the trial. On day 28, parents/guardians will be contacted to determine if their child suffered from wheeze either during the illness or at any point until day 28. Participation in the study will end on day 28. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03463694
Study type	Interventional
Source	University of Edinburgh
Contact
Status	Completed
Phase	N/A
Start date	November 2, 2018
Completion date	September 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Edinburgh and Lothian Virus Intervention Study in Kids — ELVIS Kids

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms