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New treatment option for Sinus Infection
Official title Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
ClinicalTrials.gov ID: NCT06076304
What this study is testing
What is amoxicillin/clavulanate potassium?
amoxicillin/clavulanate potassium is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sinus infection.
Also referred to as Augmentin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 18-75 years old; AND are experiencing either:
- "persistent" symptoms or signs compatible with ARS or sinus infection lasting for 1-21 days without any evidence of clinical improvement (Symptoms...
- onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge following a typical viral...
You likely can't join if
- allergy or intolerance to penicillin
- received systemic antibiotic therapy in the past 4 weeks
- prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary)
- complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs)
- health care clinician determined IV (intravenous) antibiotics or hospital admission are required
- pregnancy or breastfeeding
See the full eligibility criteria
- 18-75 years old; AND are experiencing either:
- "persistent" symptoms or signs compatible with ARS or sinus infection lasting for 1-21 days without any evidence of clinical improvement (Symptoms include facial pain or pressure, facial congestion or fullness, nasal...
- onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge following a typical viral upper respiratory infection (URI) that lasted 5-6 days and were...
- allergy or intolerance to penicillin
- received systemic antibiotic therapy in the past 4 weeks
- prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary)
- complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs)
- health care clinician determined IV (intravenous) antibiotics or hospital admission are required
- pregnancy or breastfeeding
- presence of a comorbidity or medication that may impair a patient's immune response as determined by a health care clinician
- hospitalization in past 5 days
- unable or unwilling to provide informed consent or comply with study protocol requirements
- fever \>39°C or 102°F today
- taking intranasal corticosteroids (INCS) regularly in the past two weeks and unwilling to stop its use while in the study; OR
- previously enrolled or participated in the feasibility phase or this stage of study
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Hyattsville, Maryland, United States
- Hershey, Pennsylvania, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Hyattsville, Maryland, United States; Hershey, Pennsylvania, United States; Richmond, Virginia, United States; Seattle, Washington, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.