drugset / Trial / NCT02567825
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
Completed
250 enrolled
Alejandro Hoberman
George Washington University · collabNational Institute on Deafness and Other Communication Disorders (NIDCD) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-11
- Primary completion
- 2020-03
- Completion
- 2021-02
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 90 mg/kg | — |
| Background | Ceftriaxone | Other / unclassified | 75 mg/kg | Intramuscular |
| Comparator | Ofloxacin | Small molecule | 0.3 % | Topical |