N/A
N=250
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02567825 ↗Enrolled (actual)
250
Serious AEs
4.0%
Results posted
Dec 2021
Primary outcome: Primary: The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year — 1.48; 1.56 Occurrences per child-year — p=0.66
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tympanostomy tube placement (Device); Amoxicillin-Clavulanate and/or Ceftriaxone (Drug); Ofloxacin Otic (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Alejandro Hoberman
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year |
1.48; 1.56 | 0.66 |
| SECONDARY 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 |
1.28; 1.56; 1.67; 1.56 | 0.08 |
| SECONDARY The Frequency Distribution of AOM Episodes Among Children Completing the Study |
17; 12; 41; 41; 24; 29 | 0.48 |
| SECONDARY The Distribution of Children Experiencing Treatment Failure (TF) |
56; 74; 68; 46 | — |
| SECONDARY The Time to the First Episode of AOM |
4.34; 2.33 | — |
| SECONDARY The Distribution of AOM Episodes Categorized as Probably Severe or Probably Nonsevere |
180; 168; 156; 165 | — |
| SECONDARY The Distribution of AOM Episodes Presenting With Tympanic Membrane Bulging or Otorrhea |
86; 248; 250; 85 | — |
| SECONDARY The Mean Days Per Year Children Experience Tube Otorrhea |
7.96; 2.83 | — |
| SECONDARY The Mean Days Per Year Children Experience AOM Symptoms With an Intact Tympanic Membrane (TM) |
2.00; 8.33 | — |
| SECONDARY The Mean Days Per Year Children Receive Systemic Antimicrobials for AOM |
8.76; 12.92 | — |
| SECONDARY The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported |
21; 34; 108; 87 | — |
| SECONDARY The Distribution of Children for Whom Diaper Dermatitis Was Reported |
25; 33; 104; 88 | — |
| SECONDARY The Distribution of Children for Whom Tube Otorrhea Was Reported |
94; 34; 35; 87 | — |
| SECONDARY The Distribution of Children With a Penicillin-Nonsusceptible Nasopharyngeal or Throat Isolate At Any Follow-up Visit According to the Colonization Status at Enrollment |
25; 24; 12; 11; 22; 20 | — |
| SECONDARY The Distribution of Nonsusceptible Nasopharyngeal or Throat Pathogens Recovered at Episodes of AOM |
66; 64; 107; 132 | — |
| SECONDARY The Distribution of Nonsusceptible Nasopharyngeal or Throat Pathogens Recovered at Routine Non-Illness Visits |
116; 98; 369; 349 | — |
| SECONDARY The Distribution of Nonsusceptible Nasopharyngeal or Throat Pathogens Recovered at AOM Episodes Late During the Respiratory Season (April-May) |
16; 16; 21; 27 | — |
| SECONDARY The Mean Score Representing Parental Satisfaction With Clinical Management |
4.64; 4.43 | — |
| SECONDARY The Distribution of Parent Reports Indicating At Least One Health Care Encounter Since the Previous Study Visit as an Indicator of Medical Resource Use |
738; 672; 897; 956 | — |
| SECONDARY The Distribution of Reported Occurrences of a Parent Missing Work Due to Child's Illness, as an Indicator of Non-Medical Resource Use |
286; 256; 1317; 1342; 32; 30 | — |
| SECONDARY The Distribution of Reported Occurrences of the Need for Special Childcare Arrangements Due to Child's Illness, as an Indicator of Non-Medical Resource Use |
231; 195; 1402; 1429; 2; 4 | — |
| SECONDARY The Mean Scores on the 6 Item Quality of Life Survey Questionnaire (OM-6) |
1.5; 1.55; 8.45; 8.37 | — |
| SECONDARY The Mean Scores on the 6 Item Caregiver Impact Questionnaire (CIQ) |
10.82; 10.93; 8.55; 8.50 | — |
| SECONDARY The Total Cost of Management of Recurrent Acute Otitis Media Per Quality Adjusted Life Days (QALDs) as a Measure of Cost-Effectiveness |
7.19; 5.79 | — |
| SECONDARY The Total Cost of Management of Recurrent Acute Otitis Media Per Quality Adjusted Life Days (QALDs) as a Measure of Cost-Effectiveness According to the Estimated Risk of Acute Otitis Media Recurrences at Enrollment |
6.25; 5.70; 8.00; 5.91 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 2 of these AOM episodes have been documented by trained study personnel.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02567825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.