Azithromycin for RSV-Induced Respiratory Failure
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have used Azithromycin in the 7 days before ICU admission, you cannot participate.
What data supports the effectiveness of the drug azithromycin for RSV-induced respiratory failure?
Azithromycin has shown effectiveness in treating community-acquired pneumonia by reducing clinical failures by about one-third, and it has been effective in treating respiratory infections in children, including pneumonia and bronchitis. Additionally, azithromycin has anti-inflammatory properties that may help reduce the severity of RSV infections, as suggested by studies in mouse models.12345
Is azithromycin generally safe for humans?
Azithromycin, also known as Zithromax or Zmax, is generally safe for humans. In studies involving thousands of patients, it caused fewer side effects than other antibiotics, with the most common being mild stomach issues like diarrhea and abdominal pain. Serious side effects were rare, and it was well tolerated even when taken with other medications.26789
How does the drug Azithromycin differ from other treatments for RSV-induced respiratory failure?
What is the purpose of this trial?
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.
Research Team
Michele Kong, MD
Principal Investigator
The University of Alabama at Birmingham
Eligibility Criteria
This trial is for children aged neonates to 2 years with RSV-induced respiratory failure, admitted to the ICU within 48 hours and requiring intensive breathing support. It's not for kids who've been on such support over 48 hours before ICU, have severe liver issues, chronic breathing needs at home, weakened immune systems, recent AZM use, heart problems or a history of pyloric stenosis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Azithromycin or placebo during acute hospitalization for RSV-induced respiratory failure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including length of ICU stay and duration of oxygenation
Treatment Details
Interventions
- Azithromycin
Azithromycin is already approved in European Union, United States, Canada for the following indications:
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor