Trial Summary
What is the purpose of this trial?
The investigators seek to conduct a prospective, longitudinal study to identify the dynamic changes in nasopharyngeal (NP) colonization patterns and acute otitis media (AOM) etiology involving antibiotic-resistant Streptococcus pneumoniae (Spn) and Haemophilus influenzae (Hflu).
Research Team
MP
Michael Pichichero, MD
Principal Investigator
Rochester General Hospital Research Institute
Eligibility Criteria
This trial is for healthy kids aged 6-12 months or those up to 36 months with an ear infection, who've had their full infant series of the PCV vaccine. They must be able to attend all study visits. Kids with major illnesses or in other trials within the last 28 days can't join.Inclusion Criteria
I am a healthy baby aged 6 to 12 months or up to 36 months old with an ear infection.
I have received all 3 doses of the pneumonia vaccine as a baby.
Parent/legal guardian must be able and willing to bring subject to all study visits
Exclusion Criteria
Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study
Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.
Treatment Details
Interventions
- Blood Draw (Other)
- Nasal Phalangeal Swab and Wash (Other)
- Tympanocentesis (Procedure)
Trial OverviewResearchers are studying how bacteria that cause ear infections change over time in young children's noses and ears. They're doing this by taking samples from the nose and ear, as well as blood tests, especially looking at antibiotic-resistant germs.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Healthy ChildrenExperimental Treatment3 Interventions
Samples taken from nasal swabs, nasal wash, blood draws and in the case of acute otitis media, tympanocentesis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rochester General Hospital
Lead Sponsor
Trials
14
Recruited
2,300+