Apply to Trial

Compensation: Varies

Number of Visits: 7

320 Participants Needed

Immune Response Monitoring for Ear Infection
(AOM Trial)

Overseen ByMichael Pichichero

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rochester General Hospital

Disqualifiers: Major illness, Other trials, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment used in the Immune Response Monitoring for Ear Infection trial?

The research indicates that tympanocentesis, a procedure used in the trial, can lead to rapid improvement in symptoms for children with acute ear infections. This suggests that tympanocentesis may be effective in managing symptoms of ear infections.¹ ² ³ ⁴ ⁵

Is tympanocentesis safe for monitoring ear infections?

Tympanocentesis, a procedure used to diagnose and manage ear infections, is generally considered safe, but it can cause some pain. Research has focused on methods to reduce this pain during the procedure.⁶ ⁷ ⁸ ⁹ ¹⁰

How does the treatment Tympanocentesis differ from other treatments for ear infections?

Tympanocentesis is a unique treatment for ear infections because it involves directly removing fluid from the middle ear using a needle, which can help relieve pressure and pain, and allows for precise identification of the bacteria causing the infection. This is different from standard treatments like antibiotics, which are taken orally or as ear drops and may not target the specific bacteria present.¹¹ ¹² ¹³ ¹⁴ ¹⁵

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Monitoring

Collection of middle ear fluid, nasopharyngeal samples, and blood at onset of acute otitis media and at pre-determined time points

30 months

7 visits (in-person) at ages 6, 9, 12, 15, 18, 24, and 30-36 months

Follow-up

Participants are monitored for safety and effectiveness after sample collection and monitoring

4 weeks

Treatment Details

Interventions

Blood Draw
Nasal Phalangeal Swab and Wash
Tympanocentesis

Trial Overview Researchers 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

Recruited

2,300+

Findings from Research

A meta-analysis of 82 studies found that the incidence of diarrhea and generalized rash varies significantly among different antibiotics used to treat acute otitis media in children, with high-dose amoxicillin/clavulanate showing the highest rates of diarrhea (18.9%) and rash (6.5%).

The way adverse events are reported can influence the incidence rates, suggesting that clinicians should consider both the type of antibiotic and the method of data collection when prescribing treatments for acute otitis media.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Antibiotics Used to Treat Acute Otitis Media in Children: A Systematic Meta-Analysis.Hum, SW., Shaikh, KJ., Musa, SS., et al.[2020]

References

1.United Statespubmed.ncbi.nlm.nih.gov

Acute otitis media severity of symptom score in a tympanocentesis study. [2011]

2.Denmarkpubmed.ncbi.nlm.nih.gov

Tympanometry in three-year-old children. III. Correlation between tympanometry and findings at paracentesis in a prospectively followed population of otherwise healthy children aged 3--4 years. [2019]

3.United Statespubmed.ncbi.nlm.nih.gov

Tympanocentesis for the management of acute otitis media in children: a survey of Canadian pediatricians and family physicians. [2015]

4.United Statespubmed.ncbi.nlm.nih.gov

Impedance screening for preschool children. State of the art. [2017]

5.Englandpubmed.ncbi.nlm.nih.gov

Point and period prevalence of otitis media with effusion evaluated by daily tympanometry. [2019]

6.United Statespubmed.ncbi.nlm.nih.gov

Adverse Events of Antibiotics Used to Treat Acute Otitis Media in Children: A Systematic Meta-Analysis. [2020]

7.United Statespubmed.ncbi.nlm.nih.gov

Invasive Bacterial Infections in Afebrile Infants Diagnosed With Acute Otitis Media. [2021]

8.United Statespubmed.ncbi.nlm.nih.gov

Pain management in young children undergoing diagnostic tympanocentesis. [2020]