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

NCT00405509 | Completed Results

• 1 other identifier: RC#4065
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Respiratory Infection; Common Cold

Keywords

Upper Respiratory Infection; Common Cold

Outcome Measures

Primary Outcomes (1)

• Local Leukotriene Levels

  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

Secondary Outcomes (4)

• Nasal Secretion Weights

  each day for 5 days

• Severity of Symptom Scores - COUGH

  once a day for six days and on day 30

• Severity of Symptom Score - NASAL CONGESTION

  once a day for six days and on day 30

• Severity of Symptom Score - SNEEZING

  once a day for six days and on Day 30

Study Arms (2)

Confirmed respiratory virus

Unconfirmed respiratory infection

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Penn Allegheny Health System: lead
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal brushing for genotyping

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Limitations and Caveats

Respiratory viruses were not detected in approximately 2/3 of the enrolled subjects. Future studies will need to apply more stringent inclusion/exclusion criteria to circumvent this problem.

Results Point of Contact

• Title: Deborah Gentile, MD
• Organization: Allegheny General Hospital

dgentile@wpahs.org

412-359-6654

Study Officials

• Deborah Gentile, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Allergy and Asthma Institute

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 19, 2016
• Results First Posted: September 30, 2014

Record last verified: 2016-07

Locations

US (1)