Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Summary

To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management will meaningfully improve children's acute otitis media (AOM) experience over the succeeding 2 years.

Conditions

• Acute Otitis Media

Interventions

DEVICE

Tympanostomy tube placement

As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.

DRUG

Amoxicillin-Clavulanate and/or Ceftriaxone

Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines.

DRUG

Ofloxacin Otic

Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later.

Sponsors & Collaborators

• George Washington University

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Alejandro Hoberman

  lead OTHER

Principal Investigators

• Alejandro Hoberman, MD · University of Pittsburgh School of Medicine; Children's Hospital of Pittsburgh of UPMC

• Diego Preciado, MD, PhD · George Washington University; Childrens National Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

35 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2020-03-31

Completion

2021-02-28

Countries

• United States

Study Locations