drugset / Trial / NCT06076304
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Phase 4
Recruiting
3720 enrolled
Daniel Merenstein
Medstar Health Research Institute · collabPatient-Centered Outcomes Research Institute · collabPenn State College of Medicine · collabUniversity of California, Los Angeles · collabUniversity of Washington · collabUniversity of Wisconsin, Madison · collabVirginia Commonwealth University · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
Sinus infections (also called acute rhinosinusitis or ARS) affect about 15% of adults each year, and are one of the top reasons people receive antibiotics in outpatient settings. Since most sinus infections are caused by viruses, many patients who take antibiotics for this condition do not actually benefit. Even though this has decreased over recent years, 70% of people are still prescribed them after a visit for ARS. Our goal is to better understand which patients truly benefit from antibiotics and which other treatment options can help people with sinus infections.
Timeline
- Start
- 2023-11-21
- Primary completion
- 2028-10
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin/clavulanate | Unknown | 125 mg | Oral |
| Comparator | Amoxicillin/clavulanate | Unknown | 875 mg | Oral |
| Subject | Budesonide | Small molecule | 32 ug | Intranasal |