NCT02003911

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. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

4.7 years

First QC Date

November 21, 2013

Results QC Date

February 25, 2020

Last Update Submit

August 11, 2020

Conditions

Asthma

Keywords

AsthmaAcute asthma exacerbationPediatricAzithromycinMacrolideLength of StayHospital Medicine

Outcome Measures

Primary Outcomes (1)

  • Length of Stay

    Hospital length of stay

    Admission time to discharge time (average LOS is 3 days)

Secondary Outcomes (7)

  • Readmission Rate

    One month after discharge

  • School Missed

    One month after discharge

  • Work Missed

    One month after discharge

  • Emergency Room Visits

    One month after discharge

  • Physician Office Visits

    One month after discharge

  • +2 more secondary outcomes

Other Outcomes (1)

  • Routine Clinical Results and Symptoms

    One week after discharge

Study Arms (2)

Azithromycin suspension

EXPERIMENTAL

Azithromycin suspension at 10mg/kg/dose (max 500mg) Once daily for 3 days

Drug: Azithromycin

Placebo suspension

PLACEBO COMPARATOR

Same volume as active drug Once daily for 3 days

Drug: Placebo

Interventions

AzithromycinDRUG

Azithromycin suspension (200mg/5mL)

Azithromycin suspension
PlaceboDRUG
Placebo suspension

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Limitations and Caveats

1. Early termination and power of findings 2. Urban population may not be generalizable 3. High asthma severity of participants 4. Systemic steroids given during hospitalization 5. Antimicrobial role of azithromycin (Mechanism not studied)

Results Point of Contact

Title
Dr. Lindsey Douglas
Organization
Mount Sinai Kravis Children's Hospital
lindsey.douglas@mssm.edu
2122416500

Study Officials

  • Lindsey C Douglas, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 6, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 13, 2020

Results First Posted

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)