Azithromycin for Children Hospitalized With Asthma
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Asthma
In brief
Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Despite limited clinical evidence, some pediatricians use azithromycin in children hospitalized with asthma, citing either treatment of atypical pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.
Key facts
- Study ID
- NCT02003911
- Run by
- Montefiore Medical Center
- People needed
- 159
- Starts
- 2013-10-01
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2020-08-13
Who can join
Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 4-12 years of age
- Admission diagnosis of asthma at the Children's Hospital at Montefiore
- History of persistent asthma (as defined by National Heart, Lung, and Blood Institute)
You may not qualify if…
- Concurrent bacterial infection requiring antibiotics
- Antibiotics received within previous 2 weeks
- Contraindication to azithromycin (including allergy to macrolides)
- Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis) or home oxygen requirement
- Immunodeficiency (primary or acquired)
- Chronic systemic steroid use
- Invasive or non-invasive mechanical ventilation required acutely as result of current asthma admission
- Significant cardiac co-morbidity (including hemodynamically significant cardiac disease or arrhythmia)
- Liver disease (hepatitis)
- Pregnancy
- Seizure disorder, currently on anti-epileptic medication)
- Receiving albuterol every 4 hours (q4h) at the time of enrollment
- Previous enrollment in study
Where it is running
- The Children's Hospital at Montefiore — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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