Respiratory Syncytial Virus Infections study: AZM Group
Official title Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
ClinicalTrials.gov ID: NCT05026749
What this study is testing
What is AZM?
An investigational intravenous medicine being studied for severe Respiratory Syncytial Virus (RSV) lung disease in children.
Also referred to as Azithromycin.
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
- The study wants to see if giving azithromycin during acute RSV respiratory failure helps, possibly by affecting the MMP‑9 pathway.
- Who it's for
- Children who are experiencing respiratory failure caused by RSV.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 2
You may be able to join if
- Admission to the pediatric ICU with a confirmed diagnosis of RSV infection.
- Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at \>1 L/kg/min of flow
- Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
- Onset of RSV-related symptoms must be less than 5 days
- Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.
You likely can't join if
- AZM use within 7 days of ICU admission;
- Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic...
- Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
- Intensive respiratory support greater than 48 hours prior to ICU admission;
- Chronic ventilation or supplemental oxygen need at home;
- Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
See the full eligibility criteria
- Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;
- Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at \>1 L/kg/min of flow
- Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
- Onset of RSV-related symptoms must be less than 5 days
- Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.
- AZM use within 7 days of ICU admission;
- Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL or ALT ≥ 10 times the upper...
- Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
- Intensive respiratory support greater than 48 hours prior to ICU admission;
- Chronic ventilation or supplemental oxygen need at home;
- Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
- History of pyloric stenosis;
- AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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, 3 days to 2 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.