370 Participants Needed

Azithromycin for RSV-Induced Respiratory Failure

Recruiting at 9 trial locations
MK
Overseen ByMichele Kong, MD
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Alabama at Birmingham
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Azithromycin is unique because it has a long-lasting effect, allowing for less frequent dosing, which can improve patient compliance. It also achieves higher tissue concentrations compared to other antibiotics, making it potentially more effective against certain respiratory infections.23101112

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

MK

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

I need a machine to help me breathe.
My symptoms started less than 5 days ago.
I am between 0-2 years old and was discharged home after birth if under 1 week old.
See 2 more

Exclusion Criteria

I have taken AZM within a week before being admitted to the ICU.
I have a heart condition or my heart beats irregularly with a QTc โ‰ฅ 450 ms.
I am not allergic to AZM or similar drugs and my liver functions are normal.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Azithromycin or placebo during acute hospitalization for RSV-induced respiratory failure

2 weeks
In-hospital treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including length of ICU stay and duration of oxygenation

2 weeks

Treatment Details

Interventions

  • Azithromycin
Trial Overview The ARRC trial tests if Azithromycin (AZM) helps children with acute RSV-induced respiratory failure in the ICU. Kids are randomly placed into two groups: one receiving AZM treatment and the other serving as a control group without AZM.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: AZM 20mg/kg Treatment GroupActive Control1 Intervention
Group II: Control GroupPlacebo Group1 Intervention

Azithromycin is already approved in European Union, United States, Canada for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Azithromycin for:
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Sexually transmitted diseases
  • Toxoplasmosis
  • Malaria
  • Preterm prelabor rupture of membranes
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Azithromycin for:
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Sexually transmitted diseases
  • Toxoplasmosis
  • Malaria
  • Preterm prelabor rupture of membranes
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Azithromycin for:
  • 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

Trials
1,677
Recruited
2,458,000+

Findings from Research

Prophylactic treatment with azithromycin significantly reduced weight loss and airway inflammation in RSV-infected mice, indicating its potential efficacy in managing RSV infections.
The treatment also lowered levels of inflammatory cytokines and reduced mortality in the RSV-infected group, suggesting that azithromycin could be a promising option for preventing severe outcomes in vulnerable populations.
Role of prophylactic azithromycin to reduce airway inflammation and mortality in a RSV mouse infection model.Mosquera, RA., De Jesus-Rojas, W., Stark, JM., et al.[2019]
Single-dose azithromycin (30 mg/kg) demonstrated a high clinical success rate of 88% in treating children with otitis media, based on data from four clinical trials involving 619 patients.
The treatment was found to be safe, with mostly mild and temporary side effects, and showed excellent compliance rates of 99-100%, making it a suitable alternative for pediatric patients, especially in areas with low macrolide resistance.
Single-dose azithromycin for the treatment of children with acute otitis media.Soley, CA., Arguedas, A.[2006]
In a study of 15 pediatric patients aged 1 to 10 years, azithromycin (AZM) demonstrated a high efficacy rate of 92.9% in treating various respiratory tract infections, including pneumonia and bronchitis.
The treatment was generally well-tolerated, with only one case of moderate diarrhea reported, indicating that AZM is a safe option for pediatric patients with respiratory infections.
[Pharmacokinetic and clinical evaluations of azithromycin in the pediatric field].Okada, T., Machida, Y., Fujieda, M., et al.[2016]

References

Role of prophylactic azithromycin to reduce airway inflammation and mortality in a RSV mouse infection model. [2019]
Single-dose azithromycin for the treatment of children with acute otitis media. [2006]
[Pharmacokinetic and clinical evaluations of azithromycin in the pediatric field]. [2016]
Meta-analysis of randomized controlled trials on the comparative efficacy and safety of azithromycin against other antibiotics for lower respiratory tract infections. [2019]
[Clinical effect of azithromycin adjuvant therapy in children with bronchiolitis: a systematic review and Meta analysis]. [2020]
Clinical toleration and safety of azithromycin. [2022]
Evaluation of safety and efficacy of azithromycin in lower respiratory tract infections (LRTI) [2020]
Single-dose azithromycin for respiratory tract infections. [2007]
The safety of azithromycin in the treatment of adults with community-acquired respiratory tract infections. [2022]
Azithromycin in lower respiratory tract infections. [2013]
Azithromycin use in paediatrics: A practical overview. [2021]
[Study on azithromycin in treatment of diffuse panbronchiolitis]. [2019]
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