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Acute Otitis Media and Nasopharyngeal Colonization Caused by Vaccine Serotypes of Strep Pneumoniae in Healthy Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02591563
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : April 4, 2019
Information provided by (Responsible Party):
Michael Pichichero, Rochester General Hospital

Brief Summary:
The purpose of this study is to assess the effectiveness of Prevnar 13 against pneumococcal acute otitis media.

Condition or disease Intervention/treatment
Acute Otitis Media Other: procedures

Detailed Description:
A prospective evaluation of the serotypes and antibiotic susceptibility of pneumococci colonizing the nasopharynx and causing acute otitis media in the years 2015-2019. The goal will be to recruit children into a prospective group beginning at 6 months of age and followed to 36 months of age in suburban Rochester, New York. Nasopharyngeal and oropharyngeal swabs will be obtained at each well child visit and at acute otitis media episodes. Middle ear fluid will be obtained from every child with every acute otitis media episode. Children who are otitis prone will be invited to join the prospective group thereafter (our experience to date suggests about 60% will continue in the prospective follow up). All of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 5 potential otopathogens (S. pneumoniae, nontypeable Haemophilus influenzae, M. catarrhalis, and Alloiococcus otitidis. All S. pneumoniae will undergo antibiotic susceptibility testing. All samples that are culture negative will be evaluated with a multi-locus PCR test to examine for presence of the 5 potential otopathogens.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study Evaluating Acute Otitis Media and Nasopharyngeal Colonization Caused by Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Children
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Healthy children
6-36 months of age who will have the following study procedures: Venipuncture, Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis
Other: procedures
Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture

Primary Outcome Measures :
  1. The changes in distribution of serotypes expressed by pneumococci causing acute otitis media. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
middle ear fluid, nasal swabs, blood

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy 6-36 month old children

Inclusion Criteria:

  • Male or female aged < 407 days or less than/equal to 36 months old and meets recurrent acute otitis media criteria
  • Child has received full ( 3 dose ) infant series of Prevnar 13
  • Parent/guardian willing to bring to all study visits

Exclusion Criteria:

  • Any major illness/condition that in investigator opinion would put subject at risk during study.
  • Participation in another investigational/interventional trial within 28 days prior or during study. ( Observational study is permitted )
  • Direct descendant of study site personnel.

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 identifier (NCT number): NCT02591563

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Contact: Michael E Pichichero, MD 585-922-5959

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United States, New York
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Shelley L Secor-Socha, MS, CCRA    585-233-2127   
Sponsors and Collaborators
Rochester General Hospital
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Principal Investigator: Michael E Pichichero, MD Rochester General Hospital

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Responsible Party: Michael Pichichero, MD, Director, Rochester General Hospital Research Institute, Rochester General Hospital Identifier: NCT02591563     History of Changes
Other Study ID Numbers: CIC 1610-A-15
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Otitis Media
Respiratory Tract Infections
Ear Diseases
Lung Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Immunologic Factors
Physiological Effects of Drugs