Immune Response Monitoring for Ear Infection

(AOM Trial)

Overseen By Michael Pichichero

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rochester General Hospital

Disqualifiers: Major illness, Other trials, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how bacteria in the nose and ear change over time, especially in ear infections that don't respond well to antibiotics. Researchers will collect samples using tympanocentesis, a method to take fluid from the ear, to study these changes. The trial seeks healthy children aged 6 to 12 months or those up to 36 months with an ear infection who have received their full infant series of a common pneumonia vaccine. Parents or guardians must be willing to attend all study visits. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve future treatments for ear infections.

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 prior data suggests that these procedures are safe for children?

Research has shown that tympanocentesis is generally safe for children with ear infections. This procedure involves removing pus from the middle ear and can quickly relieve symptoms like pain and fever. Studies have not reported major safety concerns from tympanocentesis itself. However, while it helps with symptoms, it does not necessarily improve the overall treatment outcome for ear infections when used alone. Overall, tympanocentesis is well-tolerated, with no major side effects reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for ear infections that often rely on antibiotics or watchful waiting, tympanocentesis offers a direct approach by draining fluid from the middle ear. This method is unique because it not only helps relieve pressure and pain but also allows for precise sampling of ear fluid to understand the immune response. Researchers are excited about tympanocentesis because it could lead to more targeted treatments by providing a clearer picture of what's happening in the ear, potentially reducing the overuse of antibiotics and improving outcomes for patients.

What evidence suggests that this trial's treatments could be effective for ear infections?

Research has shown that tympanocentesis effectively treats ear infections. This procedure involves extracting fluid from the middle ear, helping doctors identify the bacteria causing the infection. Studies indicate that removing this fluid can relieve pressure and pain, providing quick symptom relief. Tympanocentesis proves especially useful when antibiotics alone are ineffective, as it directly targets the infection. While often used for diagnosis, it also offers significant treatment benefits, particularly for antibiotic-resistant infections. ^{1 5 6 7 8}

Who Is on the Research Team?

Michael Pichichero, MD

Principal Investigator

Rochester General Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Healthy Children Experimental Treatment 3 Interventions

Samples taken from nasal swabs, nasal wash, blood draws and in the case of acute otitis media, tympanocentesis

Who Is Running the Clinical Trial?

Rochester General Hospital

Lead Sponsor

Trials

14

Recruited

2,300+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10231305/

New insights into the treatment of acute otitis media - PMC When an antibiotic is prescribed, microbiologic studies indicate that organisms are eradicated from the middle ear within a range of 3–6 days [102]. In children ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470332/

Acute Otitis Media - StatPearls - NCBI Bookshelf - NIH Acute otitis media (AOM) is defined as an infection of the middle ear and is the second most common pediatric diagnosis in the emergency department.

3. aafp.org aafp.org/pubs/afp/issues/2019/0915/p350.html

Otitis Media: Rapid Evidence Review Tympanometry can be used as an adjunct to pneumatic otoscopy. Tympanometry is also 70% to 94% sensitive and 90% specific for identifying middle ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/191139

Assessing Diagnostic Accuracy and Tympanocentesis ... To assess the ability of pediatricians and otolaryngologists to differentiate the physical findings of AOM and OME, an examination using video images was ...

5. uptodate.com uptodate.com/contents/acute-otitis-media-in-adults

Acute otitis media in adults - UpToDate A South Korean study analyzing middle ear fluid from a mixed adult and pediatric population with AOM and spontaneous tympanic membrane ...

6. aafp.org aafp.org/pubs/afp/issues/2000/0401/p1987.html

Tympanocentesis: To Tap or Not to Tap Tympanocentesis provides no improvement either alone or in combination with an antibiotic in the treatment of acute otitis media.

7. nejm.org nejm.org/doi/full/10.1056/NEJMvcm0706756

Tympanocentesis in Children with Acute Otitis Media In children with acute otitis media, drainage of pus from the middle ear results in a rapid and marked improvement in symptoms and enables ...

8. publications.aap.org publications.aap.org/pediatrics/article/131/3/e964/30912/The-Diagnosis-and-Management-of-Acute-Otitis-Media

The Diagnosis and Management of Acute Otitis Media Primary outcome was pain and/or fever (>38°C) at 3 to 7 days. The adverse effects of antibiotics were also analyzed. Baseline predictors were age <2 years ...