Ongoing Clinical Trials for Bacterial Sinusitis
There is currently 1 ongoing clinical trial investigating treatment options for bacterial sinusitis. This trial is examining the effectiveness of the antibiotic azithromycin in treating chronic forms of the condition that have not responded to standard treatments. The study is being conducted in France and focuses on adults with persistent sinus infections.
Clinical trial locations
Study on Azithromycin for Treating Chronic Sinusitis in Adults
This clinical trial is investigating the use of azithromycin, a commonly prescribed antibiotic, for the treatment of chronic rhinosinusitis that has proven resistant to standard treatment approaches. The condition being studied involves long-lasting inflammation of the sinuses with persistent pus-like discharge that causes symptoms such as nasal congestion, facial pain, and a runny nose.
Who can participate:
- Adults between 18 and 70 years of age
- People who have had chronic rhinosinusitis for more than 12 weeks, confirmed by nasal examination and CT scan showing specific changes in the sinuses
- Those with ongoing purulent rhinosinusitis that has not improved despite at least two courses of antibiotics
- Individuals who are members of or beneficiaries of a health insurance plan
- Those who can provide informed consent to participate in the study
Who cannot participate:
- People with other significant health problems not related to ear, nose, and throat conditions
- Those currently participating in another clinical trial
- Individuals who have had ear, nose, or throat surgery within the last 3 months
- People unable to follow study procedures or attend follow-up visits
- Pregnant or breastfeeding women
- Those with known allergies to any of the study medications
- People using medications that might interfere with study results
- Individuals with a history of drug or alcohol abuse
- Those with mental health conditions that might affect their ability to participate
What the trial involves:
The main focus of this trial is to evaluate whether a three-month continuous treatment with azithromycin can improve the quality of life for adults suffering from this type of treatment-resistant sinusitis. Participants will receive either azithromycin or a placebo, which is an inactive substance with no medication.
The trial will follow a structured timeline. After an initial assessment including medical history review, physical examination, nasal endoscopy, and CT scan, participants will enter a three-month treatment phase. During this period, they will take the medication as prescribed and report any side effects or changes in their condition. Regular monitoring will be conducted throughout, including follow-up visits to assess response to treatment and monitor for any adverse effects.
Participants will be asked to complete the Sino-Nasal Outcome Test 22 (SNOT 22), a questionnaire designed to evaluate how sinus symptoms affect quality of life. At the end of the three-month treatment period, a final assessment will include repeat nasal endoscopy and CT scan to evaluate changes in sinus condition, along with another SNOT 22 questionnaire to measure any improvements.
The study will examine various aspects of participants’ health, including the frequency of sinus infections, the need for additional antibiotics, and changes in symptoms. Researchers will also assess the treatment’s impact on daily activities such as work ability and sense of smell. A post-treatment follow-up period will monitor any residual effects of the treatment.
Investigational drug:
Azithromycin is a macrolide antibiotic commonly used to treat various bacterial infections affecting the ear, nose, and throat. It works by inhibiting the growth of bacteria, thereby reducing infection and inflammation. In this trial, azithromycin is administered orally in tablet or liquid form over a continuous three-month period. The study aims to determine whether this extended treatment regimen can provide significant relief for those suffering from chronic rhinosinusitis that has not responded to standard antibiotic courses.
Summary
Currently, there is only one active clinical trial investigating treatments for bacterial sinusitis. This trial is taking place in France and focuses specifically on chronic cases that have proven difficult to treat with standard antibiotic therapy. The study examines azithromycin, a well-established antibiotic, but tests it in a longer treatment course than typically prescribed. The trial’s design includes comprehensive assessments before, during, and after treatment to carefully measure any improvements in both clinical signs and patients’ quality of life. This focused approach reflects the ongoing challenge of treating resistant forms of chronic sinusitis and the need for evidence-based treatment options for patients who do not respond to conventional therapy.
