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Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids)

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ClinicalTrials.gov Identifier: NCT03463694
Recruitment Status : Unknown
Verified April 2019 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : March 13, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Brief 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).

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Virus Virus Shedding Pediatric ALL Other: Na Cl solution Not Applicable

Detailed 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 the Children's Clinical Research Facility (CCRF) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of HS nose drops (~2.6% NaCl) vs. standard care in children <7 years of age with symptoms of an URTI.
Masking: Single (Outcomes Assessor)
Masking Description: The team in the virology lab carrying out the analysis of the nasal swabs will be blinded to the allocation of the participant.
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypertonic Saline ~2.6% NaCl
3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
Other: Na Cl solution
~2.6% NaCl solution prepared from sea salt

No Intervention: Standard Care
Control arm of standard symptomatic care only



Primary Outcome Measures :
  1. Time to the first report that the child is "not unwell". [ Time Frame: Maximum of 28days ]
    Time until child not unwell


Secondary Outcome Measures :
  1. Severity of all symptoms [ Time Frame: 1-28 days (or until child is well) ]
    Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable

  2. The length of time for individual symptoms to resolve [ Time Frame: 1-28 days (or until child is well) ]
    Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable

  3. Severity of individual symptoms [ Time Frame: 1-28 days (or until child is well) ]
    Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable

  4. Contacting healthcare (NHS 24, OOH, GP) -Number of participants [ Time Frame: 1-28 days (or until child is well) ]
    Number of participants

  5. Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts [ Time Frame: 1-28 days (or until child is well) ]
    Number of contacts

  6. Participants needing GP appointments- Number of participants [ Time Frame: 1-28 days (or until child is well) ]
    Number of appointments

  7. Participants needing GP appointments- Frequency of contacts [ Time Frame: 1-28 days (or until child is well) ]
    Number of appointments

  8. Number of participants attending hospital and diagnosis - Number of participants [ Time Frame: 1-28 days (or until child is well) ]
    Number of participants

  9. Number of participants attending hospital and diagnosis - Frequency of contacts [ Time Frame: 1-28 days (or until child is well) ]
    Number of attendances

  10. Length of stay in hospital if admitted [ Time Frame: 1-28 days (or until child is well) ]
    Length in Days

  11. Number of participants reporting wheeze during illness and between end of illness to 28 days [ Time Frame: Day 28 ]
    Number reporting wheeze

  12. Number of participants reporting over the counter medication use [ Time Frame: 1-28 days (or until child is well) ]
    Number of participants

  13. Duration of viral shedding [ Time Frame: Days 1-5 ]
    Viral shedding duration in days

  14. Reduction in viral shedding [ Time Frame: Days 1-5 ]
    Log conversion of each positive result will be done using the following formula: (40-CT of specimen)/3.3 to estimate change in shedding.

  15. Rate of reduction in viral shedding [ Time Frame: Days 1-5 ]
    Rate of viral shedding duration in days

  16. Reduction in transmission to household contacts [ Time Frame: 1-28 days (or until child is well) ]
    Questionnaire - reported number of adults and children catching URTI

  17. Number of participants reporting side effects of nasal drops [ Time Frame: 1-28 days (or until child is well) ]
    Side effects reported

  18. Types and severity of side effects reported [ Time Frame: 1-28 days (or until child is well) ]
    Side effects reported

  19. Number of days lost from school/nursery for child [ Time Frame: 1-28 days (or until child is well) ]
    Number of days

  20. Number of days lost from work for parent/guardian [ Time Frame: 1-28 days (or until child is well) ]
    Number of days

  21. Cost of over the counter medication used [ Time Frame: 1-28 days (or until child is well) ]
    Cost of medicine used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Weeks to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Otherwise healthy children between corrected gestational age of 40 weeks and <7 years of age without URTI OR ≤48 hours of URTI* starting.

*A URTI being defined as at least two respiratory symptoms (nasal stuffiness , 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 on 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 are unable to comply with the study protocol
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463694


Contacts
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Contact: Sandeep Ramalingham 0131 242 6014 Sandeep.Ramalingam@nhslothian.scot.nhs.uk
Contact: Kat Oatey 0131 651 9913 elvis.kids@ed.ac.uk

Locations
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United Kingdom
Childrens' Clinical Research Facility Recruiting
Edinburgh, United Kingdom, EH9 1LF
Contact: Sandeep Ramalingam         
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Sandeep Ramalingham NHS Lothian
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03463694    
Other Study ID Numbers: ELVIS Kids
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases