Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years

20. juli 2016 opdateret af: Deborah Gentile, West Penn Allegheny Health System

The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years

This study examines the cold processes of children aged 6 to less than 14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Leukotrienes are chemicals that are naturally made by your body. Leukotrienes are increased in the bodies of adults and children with asthma and allergies and cause some of the symptoms of these diseases. Leukotrienes are increased in the bodies of adults who have common colds and are believed to cause some of the symptoms of the common cold. It is not known if increases in leukotrienes are related to the symptoms of the common cold in children. There are also genes that may control levels of leukotrienes and other chemicals in your body during the common cold. If you enroll your child in this study, he/she will be tested for allergies and for genes that may control the levels of leukotrienes and other chemicals.

STUDY DESIGN:

There will be 40 subjects enrolled into the study between the ages of 6 to < 14 years of age. However, approximately 80 participants may have to sign the consent form and undergo screening activities in order enroll these 40 subjects. The study will last approximately 1 month and will require you and your child to return to our clinic approximately 7 times over the study duration. You and your child will be required to return to our clinic six days in a row for testing.

Testing will include skin testing for allergies, nasal secretion collection, and skin cell collection.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

33

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 13 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Male and Female subjects ages 6 to under 14 years with common cold symptoms of less than 24 hours in duration.

Beskrivelse

Inclusion Criteria:

  • Children 6 to < 14 years of age.
  • Common cold symptoms for less than 24 hours.
  • At least 2 of the following 8 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, and sneezing.

Exclusion Criteria:

  • Investigational medication in past 30 days.
  • History of persistent asthma or other chronic diseases.
  • Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
  • Patients with evidence of significant nasal septal deviation.
  • Patients with a positive rapid antigen test for streptococcal infection.
  • Common cold symptoms for more than 24 hours.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Confirmed respiratory virus
Unconfirmed respiratory infection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Local Leukotriene Levels
Tidsramme: once a day for 6 days and on day 30
nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels
once a day for 6 days and on day 30

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nasal Secretion Weights
Tidsramme: each day for 5 days
Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
each day for 5 days
Severity of Symptom Scores - COUGH
Tidsramme: once a day for six days and on day 30
Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
once a day for six days and on day 30
Severity of Symptom Score - NASAL CONGESTION
Tidsramme: once a day for six days and on day 30
nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
once a day for six days and on day 30
Severity of Symptom Score - SNEEZING
Tidsramme: once a day for six days and on Day 30
Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
once a day for six days and on Day 30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

West Penn Allegheny Health System

Samarbejdspartnere

Merck Sharp & Dohme LLC
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2006

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

28. november 2006

Først indsendt, der opfyldte QC-kriterier

28. november 2006

Først opslået (Skøn)

30. november 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC#4065

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forkølelse

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner