Edinburgh and Lothian Virus Intervention Study in Kids

Pediatric ALL Clinical Trial

— ELVIS Kids  

Official title:

Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids): A Randomised Controlled Trial of Hypertonic Saline Nose Drops in Children With Upper Respiratory Tract Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03463694
• Other study ID #: ELVIS Kids
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2022
• Source: University of Edinburgh
• Contact: Sandeep Ramalingham
• Phone: 0131 242 6014
• Email: Sandeep.Ramalingam[@]nhslothian.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Weeks to 7 Years

Eligibility

INCLUSION CRITERIA

1. Children between corrected gestational age of =40 weeks and <7 years of age

2. Children without URTI OR =48 hours of URTI* starting.

• A URTI being defined as at least two respiratory symptoms (nasal congestion (i.e. stuffy nose), runny nose, cough, sore throat) OR one respiratory symptom + at least one systemic symptom (Low energy/tired, muscle aches/pains, headache, fever =38°C). EXCLUSION CRITERIA

1. Children needing immediate medical attention

2. Children using saline drops/sprays at the time of randomisation

3. Children on immunosuppressive medication, regular oral/inhaled steroids, regular antibiotics (use of antibiotics is allowed as long as the child does not need regular antibiotics)

4. Children with a known chronic illness (e.g. cystic fibrosis, cardiac, renal, liver, lung, neurological conditions) apart from wheeze or asthma which are not exclusions if the child is otherwise well and not on regular steroids)

5. Children being followed up for developmental delay

6. Children receiving the nasal flu vaccine =14 days ago

7. Children taking part in another interventional trial

8. If parents/guardians indicating that they are unable to comply with the study protocol prior to randomisation

9. If parents/guardians are unable to understand written or spoken English

10. Children randomised to ELVIS KIDS on a previous episode of URTI

11. Children with a concurrently participating sibling

Related Conditions & MeSH terms

• Infections
• Pediatric ALL
• Respiratory Tract Infections
• Upper Respiratory Tract Infections
• Virus
• Virus Diseases
• Virus Shedding

Intervention

Other:
• Na Cl solution
~2.6% NaCl solution prepared from sea salt

Locations

Country	Name	City	State
United Kingdom	Childrens' Clinical Research Facility	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first report that the child is "not unwell".	Time until child not unwell	Maximum of 28days
Secondary	Severity of all symptoms	Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable	1-28 days (or until child is well)
Secondary	The length of time for individual symptoms to resolve	Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable	1-28 days (or until child is well)
Secondary	Severity of individual symptoms	Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable	1-28 days (or until child is well)
Secondary	Contacting healthcare (NHS 24, OOH, GP) -Number of participants	Number of participants	1-28 days (or until child is well)
Secondary	Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts	Number of contacts	1-28 days (or until child is well)
Secondary	Participants needing GP appointments- Number of participants	Number of appointments	1-28 days (or until child is well)
Secondary	Participants needing GP appointments- Frequency of contacts	Number of appointments	1-28 days (or until child is well)
Secondary	Number of participants attending hospital and diagnosis - Number of participants	Number of participants	1-28 days (or until child is well)
Secondary	Number of participants attending hospital and diagnosis - Frequency of contacts	Number of attendances	1-28 days (or until child is well)
Secondary	Length of stay in hospital if admitted	Length in Days	1-28 days (or until child is well)
Secondary	Number of participants reporting wheeze during illness and between end of illness to 28 days	Number reporting wheeze	Day 28
Secondary	Number of participants reporting over the counter medication use	Number of participants	1-28 days (or until child is well)
Secondary	Duration of viral shedding	Viral shedding duration in days	Days 1-5
Secondary	Reduction in viral shedding	Log conversion of each positive result will be done using the following formula: (40-CT of specimen)/3.3 to estimate change in shedding.	Days 1-5
Secondary	Rate of reduction in viral shedding	Rate of viral shedding duration in days	Days 1-5
Secondary	Reduction in transmission to household contacts	Questionnaire - reported number of adults and children catching URTI	1-28 days (or until child is well)
Secondary	Number of participants reporting side effects of nasal drops	Side effects reported	1-28 days (or until child is well)
Secondary	Types and severity of side effects reported	Side effects reported	1-28 days (or until child is well)
Secondary	Number of days lost from school/nursery for child	Number of days	1-28 days (or until child is well)
Secondary	Number of days lost from work for parent/guardian	Number of days	1-28 days (or until child is well)
Secondary	Cost of over the counter medication used	Cost of medicine used.	1-28 days (or until child is well)