Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
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|ClinicalTrials.gov Identifier: NCT02567825|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2015
Last Update Posted : October 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media||Procedure: Tympanostomy tube placement Procedure: Nonsurgical management||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Subjects in the randomization phase of the study will be randomized to either medical management or tube surgery. No masking will occur.|
|Official Title:||Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||February 2021|
Active Comparator: Treatment A- surgical management
Tympanostomy tube placement
Procedure: 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. Participants will be followed overtime for recurrences of AOM and treated with topical antimicrobials.
Treatment B - nonsurgical management
Procedure: Nonsurgical management
Participants will be followed overtime for recurrences of AOM and treated with systemic antimicrobials.
- Acute Otitis Media rate [ Time Frame: 2 years ]Average number of AOM episodes during the 2-year follow-up period.
- Severity of AOM episodes per American Academy of Pediatrics definitions [ Time Frame: 2 years ]Comparison of the proportion of AOM recurrences categorized as severe vs. non-severe using the American Academy of Pediatrics definition (severe, indicated by moderate or severe otalgia or temperature ≥39°C vs. non-severe, indicated by mild otalgia or temperature <39°C).
- Severity of AOM episodes per AOM-Severity of Symptoms Score [ Time Frame: 2 years ]Comparison of AOM-Severity of Symptoms scores at Days 1 and Day 5 of AOM recurrences
- Frequency distribution of AOM recurrences [ Time Frame: 2 years ]
- Time to first AOM recurrence [ Time Frame: 2 years ]
- Type of recurrences [ Time Frame: 2 years ]Proportion of AOM recurrences presenting with intact bulging tympanic membrane or tube otorrhea
- Antibiotic utilization [ Time Frame: 2 years ]Total days per year subjects receive systemic antimicrobials for AOM
- Selected adverse events [ Time Frame: 2 years ]Proportion of children with selected adverse events (protocol defined diarrhea, diaper dermatitis, chronic otorrhea)
- Antibiotic resistance of nasopharyngeal pathogens [ Time Frame: 2 years ]Secondary endpoints concerning resistance include (1) proportion of children whose nasopharyngeal cultures at randomization are, respectively, either negative for S. pneumoniae and H. influenzae, or positive for penicillin-susceptible pathogens, or positive for one or more penicillin-nonsusceptible pathogens, who subsequently are found on a follow-up nasopharyngeal culture to harbor one or more penicillin-nonsusceptible pathogens; (2) proportion of interim, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered; and (3) for all AOM episodes, the proportions of S. pneumoniae and H. influenzae isolates recovered at a visit during April or May (end of the respiratory season) that are penicillin nonsusceptible.
- Cost-effectiveness [ Time Frame: 2 years ]Greater cost-effectiveness in children at higher-risk for rAOM than in children at lower-risk. Cost effectiveness of each treatment strategy will be calculated by dividing the costs of each strategy by its effectiveness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567825
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||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|