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Azithromycin for Children Hospitalized With Asthma

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ClinicalTrials.gov Identifier: NCT02003911
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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. We propose a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerabations.

Condition or disease Intervention/treatment Phase
Asthma Drug: Azithromycin Drug: Placebo Phase 4

Detailed Description:

Asthma is a chronic lung condition that accounts for over 130,000 pediatric hospitalizations nationally at a cost of almost 1.4 billion dollars. The Children's Hospital at Montefiore is located in an area with one of the highest asthma rates in the United States: Bronx, New York. Atypical pathogens have been implicated both in initiating asthma and triggering acute asthma exacerbations. Azithromycin, a macrolide antibiotic, is known to have antibacterial activity against atypical pathogens and gram positive bacteria. More recently, macrolides have been increasingly used and effective against gram negative bacteria and inflammation in the lungs of patients with chronic respiratory illnesses. This effect may be secondary to the immunomodulary effects macrolides possess, in addition to their anti-bacterial effects. In long-term therapy with macrolides, patients with asthma have shown improved bronchiolar hyperreactivity, spirometry, symptoms, and quality of life. However, studies of short-term treatment in the acute setting and in children are limited. Some practitioners use azithromycin in the treatment of acute asthma, despite limited data.

The investigators propose a double-blind, randomized, placebo-controlled trial of azithromycin in children aged 4-12 years with persistent asthma hospitalized with acute asthma exacerbations. Children will be enrolled within 12 hours of admission and will be randomized to receive three days of either azithromycin or placebo suspension (10mg/kg/dose, max of 500mg). The primary outcome measure will be length of stay (LOS). Secondary outcome measures will include: days of school/work missed, readmission rates, return to medical care rates, recurrence of symptoms, and steroid courses. In the future, patients may also be approached to enroll in the "Mechanism Subset Study" a separate pilot and feasibility study which will require two blood samples and two nasal aspirate samples and will test for atypical pathogens, intraleukin-8 levels, and neutrophil/eosinophil counts. The average length of stay for patients in this age range with asthma in 2011 at our institution was 3.0 days. The investigators will enroll to achieve a power of 80%, with an alpha of 0.05, which will require 107 patients in each group to detect a 16 hour (0.67 day) difference in the primary outcome, LOS. We hypothesize that azithromycin treatment in children hospitalized with acute asthma will decrease LOS.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial of Azithromycin in Children Hospitalized With Acute Asthma Exacerbations
Study Start Date : October 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Azithromycin suspension

Azithromycin suspension at 10mg/kg/dose (max 500mg)

Once daily for 3 days

Drug: Azithromycin
Azithromycin suspension (200mg/5mL)
Placebo Comparator: Placebo suspension

Same volume as active drug

Once daily for 3 days

Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Length of Stay [ Time Frame: Admission time to discharge time (average LOS is 3 days) ]
    Hospital length of stay


Secondary Outcome Measures :
  1. Readmission rate [ Time Frame: One month after discharge ]
    Number of hospital readmissions for asthma at telephone follow-up phone calls at 1-week and 1-month interval after discharge

  2. School missed [ Time Frame: One month after discharge ]
    Days of school missed by patient at telephone follow-up phone calls at 1-week and 1-month interval after discharge

  3. Work missed [ Time Frame: One month after discharge ]
    Days of work missed by parent/guardian at telephone follow-up phone calls at 1-week and 1-month interval after discharge

  4. Emergency room visits [ Time Frame: One month after discharge ]
    Number of emergency room visits for asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge

  5. Physician office visits [ Time Frame: One month after discharge ]
    Number of physician office visits for asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge

  6. Recurrence of asthma symptoms [ Time Frame: One month after discharge ]
    Number of recurrences of asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge

  7. Steriod courses [ Time Frame: One month after discharge ]
    Number of courses of oral steroids since discharge at telephone follow-up phone call 1-month after discharge


Other Outcome Measures:
  1. Routine clinical results and symptoms [ Time Frame: One week after discharge ]
    Respiratory viral panel or rapid viral testing results (if obtained as part of medical care), chest x-ray results/lab results (if obtained as part of medical care), vital signs, medications received during admission, medication side effects (diarrhea, abdominal pain, vomiting, flatulence), transfer to intensive care unit, time of wean of beta-agonists (q3h and q4h), and asthma severity (PASS score) at time of enrollment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003911


Contacts
Contact: Lindsey C Douglas, MD 718-741-2470 douglas@montefiore.org
Contact: Alyssa Silver, MD 718-741-2304 alysilve@montefiore.org

Locations
United States, New York
The Children's Hospital at Montefiore Recruiting
The Bronx, New York, United States, 10467
Principal Investigator: Lindsey C Douglas, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Lindsey C Douglas, MD Montefiore Medical Center
Study Director: Katherine O'Connor, MD Montefiore Medical Center
Study Director: Diana S. Lee, MD Montefiore Medical Center
Study Director: Alyssa H Silver, MD Montefiore Medical Center
More Information

Responsible Party: Lindsey Douglas, Attending, Division of Hospital Medicine, Assistant Professor, Albert Einstein College of Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02003911     History of Changes
Other Study ID Numbers: 12-05-187
12-05-187 ( Other Identifier: Montefiore IRB # )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lindsey Douglas, Montefiore Medical Center:
Asthma
Acute asthma exacerbation
Pediatric
Azithromycin
Macrolide
Length of Stay
Hospital Medicine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases