Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
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|ClinicalTrials.gov Identifier: NCT02567825|
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : March 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media||Device: Tympanostomy tube placement Drug: Amoxicillin-Clavulanate and/or Ceftriaxone Drug: Ofloxacin Otic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 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|
|Actual Primary Completion Date :||March 2020|
|Actual Study Completion Date :||February 2021|
Active Comparator: Surgical Management
Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops
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: Ofloxacin Otic
Participants randomized to receive tympanovstomy 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.
Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone
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.
- 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|