Azithromycin for Wheezing in Preschoolers
(AZ-SWED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the antibiotic Azithromycin can help preschoolers with severe wheezing episodes. Researchers aim to determine if a 5-day Azithromycin treatment is more effective than a placebo, particularly for children with specific nasal bacteria. The trial includes daily check-ins to monitor symptoms and may require a few follow-up visits. It is designed for children aged 18 months to under 5 years who have been diagnosed with wheezing in the emergency room and have not recently used similar medications or had certain other health issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering an opportunity to contribute to a potentially groundbreaking treatment for wheezing in children.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have used systemic antibiotics or steroids for wheezing in the last 2 weeks. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that azithromycin is generally safe for children with wheezing and breathing problems, typically causing few side effects. For instance, one study found that azithromycin reduced hospital stays for children with wheezing, demonstrating its effectiveness without major issues.
Another study supports its use for upper respiratory infections, highlighting its safety and effectiveness. Thus, azithromycin is a safe choice for managing wheezing in young children. However, like any medicine, it may cause side effects such as stomach upset or diarrhea, though serious side effects are rare.
Overall, existing studies confirm that azithromycin is a safe option for children with wheezing.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for wheezing in preschoolers, which typically involve corticosteroids or bronchodilators, Azithromycin offers a different approach by targeting bacterial infections that might be contributing to the wheezing episodes. This antibiotic is unique because it not only addresses potential underlying infections but also has anti-inflammatory properties, which can help reduce airway inflammation more effectively. Researchers are excited about Azithromycin because it could provide quicker relief from wheezing and potentially reduce the frequency of episodes, offering a dual benefit that isn't typical with current medications.
What evidence suggests that Azithromycin might be an effective treatment for wheezing in preschoolers?
This trial will compare Azithromycin with a placebo to evaluate its effectiveness in treating wheezing in preschoolers. Studies have shown mixed results regarding Azithromycin's efficacy for this condition. Some research found that Azithromycin might help children leave the hospital sooner during severe wheezing episodes. However, other studies found it doesn't significantly reduce the severity of wheezing, even when bacteria are present. Evidence also indicates that it does not prevent future wheezing after serious respiratory illnesses. Overall, while Azithromycin may help in some situations, its overall effect on wheezing severity in young children remains uncertain.36789
Who Is on the Research Team?
Charlie Casper, PhD
Principal Investigator
University of Utah
Kurt Denninghoff, MD
Principal Investigator
University of Arizona
Fernando D Martinez, MD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for preschool children aged 18 months to under 60 months who are experiencing a severe wheezing episode and have been assessed at the emergency department. They must not have used antibiotics or steroids for wheezing in the past two weeks, among other health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Azithromycin or placebo for 5 days, with daily electronic transmission of the Asthma Flare-up Diary for Young Children (ADYC) and daily contact for compliance and complications assessment
Follow-up
A subset of participants will have follow-up visits to assess antibiotic resistance and treatment response related changes in the airway microbiome
What Are the Treatments Tested in This Trial?
Interventions
- Azithromycin
- Placebo
Trial Overview
The AZ-SWED study tests if Azithromycin (12 mg/kg/day for 5 days) helps improve severe wheezing episodes in young children compared to a placebo. The effect is measured using daily caregiver reports and follow-up visits, with some focus on bacterial presence.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered the active drug per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered placebo per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.
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 Arizona
Lead Sponsor
University of Utah
Collaborator
Emory University
Collaborator
Morgan Stanley Children's Hospital
Collaborator
University of Pittsburgh
Collaborator
Children's Hospital and Health System Foundation, Wisconsin
Collaborator
Children's Hospital of Philadelphia
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Boston Children's Hospital
Collaborator
Citations
Azithromycin during Wheezing Illnesses among Preschool ...
The primary outcome of the parent study was positive, with azithromycin ... Unfortunately, there are no data presented on the direct effect of azithromycin ...
Azithromycin for acute bronchiolitis and wheezing ...
Azithromycin may reduce hospitalization time in acute bronchiolitis and wheezing episodes among children aged less than two. Azithromycin ...
Azithromycin does not reduce illness severity in ...
Azithromycin did not decrease the severity of wheezing illnesses in these children, even if they were positive for bacteria that are considered usually ...
Azithromycin to Prevent Recurrent Wheeze Following Severe ...
Azithromycin therapy for 14 days during acute severe RSV bronchiolitis did not reduce recurrent wheeze occurrence over the following 2 to 4 years.
Study Details | NCT04669288 | AZithromycin Therapy in ...
The trial will compare the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated ...
Azithromycin for acute bronchiolitis and wheezing ...
Impact · Azithromycin may reduce hospitalization time in acute bronchiolitis and wheezing episodes among children aged less than two.
The Efficacy, Safety, and Economic Outcomes of Using ...
Azithromycin exhibits a favorable risk-benefit profile in management of Upper RTIs, supported by its superior clinical efficacy, safety, and cost-effectiveness.
8.
clinicalepigeneticsjournal.biomedcentral.com
clinicalepigeneticsjournal.biomedcentral.com/articles/10.1186/s13148-023-01430-yAzithromycin attenuates wheezing after pulmonary ...
These data suggested that AZM has a positive effect on wheezing diseases after pulmonary inflammation. Here, we explored whether AZM exhibits ...
The Effect of Long-Term Azithromycin on Objective and ...
Azithromycin therapy improves cough-related quality of life in various chronic respiratory diseases; however, there was no significant effect on cough outcomes.
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