Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

NCT02567825 | Completed Results DMC

• 2 other identifiers: PRO150601481U01DC013995-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ear infection; antibiotics; infants; children; pediatrics; tympanostomy tubes

Outcome Measures

Primary Outcomes (1)

• The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year

  An episode of AOM is considered a discrete occurrence if symptoms and signs persisted for, or recurred, 17 or more days after the start of antimicrobial treatment. The rate is calculated by dividing the total number of occurrences by the total number of years of follow-up. Multiple imputation was used when follow-up was incomplete.

  Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed.

Secondary Outcomes (24)

• The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment

  Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed.

• The Frequency Distribution of AOM Episodes Among Children Completing the Study

  Day 1 until Day 786. For children completing the study, the mean length of follow-up was 726 days.

• The Distribution of Children Experiencing Treatment Failure (TF)

  Day 1 until Day 786.

• The Time to the First Episode of AOM

  Day 1 until Day 786. The mean length of follow-up was 662 days / 21.8 months.

• The Distribution of AOM Episodes Categorized as Probably Severe or Probably Nonsevere

  Day 1 until Day 786.

Study Arms (2)

Surgical Management

ACTIVE COMPARATOR

Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops

Device: Tympanostomy tube placement; Drug: Ofloxacin Otic

Non-Surgical Management

OTHER

Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone

Drug: Amoxicillin-Clavulanate and/or Ceftriaxone

Interventions

Tympanostomy tube placement DEVICE

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.

Surgical Management

Amoxicillin-Clavulanate and/or Ceftriaxone DRUG

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.

Non-Surgical Management

Ofloxacin Otic DRUG

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.

Surgical Management

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• are aged 6-35 months,
• have rAOM, defined as the occurrence of 3 AOM episodes in 6 months or 4 episodes in 12 months with ≥1 episode in the preceding 6 months, and
• of these AOM episodes have been documented by trained study personnel.

You may not qualify if:

• have a history of TTP,
• have a chronic illness (cystic fibrosis, neoplasm, juvenile diabetes, renal or hepatic insufficiency, immune dysfunction, malabsorption, inflammatory bowel disease, severe asthma requiring at least 4 courses of oral corticosteroids during the last 12 months),
• are allergic to amoxicillin,
• have a congenital anomaly that might increase the risk of recurrences (e.g., cleft palate, Down's syndrome),
• have had otitis media effusion for at least 3 months in addition to rAOM, or
• have sensorineural hearing loss.

Sponsors & Collaborators

• Alejandro Hoberman: lead
• George Washington University: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (2)

• Noorbakhsh KA, Liu H, Kurs-Lasky M, Smith KJ, Hoberman A, Shaikh N. Cost-Effectiveness of Management Strategies in Recurrent Acute Otitis Media. J Pediatr. 2023 May;256:11-17.e2. doi: 10.1016/j.jpeds.2022.11.032. Epub 2022 Dec 5.

  PMID: 36470464 DERIVED

• Hoberman A, Preciado D, Paradise JL, Chi DH, Haralam M, Block SL, Kearney DH, Bhatnagar S, Muniz Pujalt GB, Shope TR, Martin JM, Felten DE, Kurs-Lasky M, Liu H, Yahner K, Jeong JH, Cohen NL, Czervionke B, Nagg JP, Dohar JE, Shaikh N. Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media. N Engl J Med. 2021 May 13;384(19):1789-1799. doi: 10.1056/NEJMoa2027278.

  PMID: 33979487 DERIVED

MeSH Terms

Conditions

Otitis Media; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Alejandro Hoberman, MD
• Organization: UPMC Children's Hospital of Pittsburgh

hobermana@upmc.edu

412-999-3277

Study Officials

• Alejandro Hoberman, MD

  University of Pittsburgh School of Medicine; Children's Hospital of Pittsburgh of UPMC

  PRINCIPAL INVESTIGATOR

• Diego Preciado, MD, PhD

  George Washington University; Childrens National Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects in the randomization phase of the study will be randomized to either medical management or tube surgery. No masking will occur.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: February 1, 2021
• Last Updated: July 15, 2022
• Results First Posted: December 10, 2021

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)