Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

NACompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

March 31, 2020

Study Completion Date

February 28, 2021

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.

Trial Locations (2)

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

20010

Children's National Medical Center, Washington D.C.

All Listed Sponsors
collaborator

George Washington University

OTHER

collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

lead

Alejandro Hoberman

OTHER

NCT02567825 - Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media | Biotech Hunter | Biotech Hunter