Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544984
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo A. Mosquera, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to determine if the prophylactic use of azithromycin will reduce the total number of days when unscheduled treatment is given outside of the home in a clinic, urgent care, emergency room or hospital setting between the respiratory illness season months (October 1-March 31) and subsequent 2 month follow-up (April and May)

Condition or disease Intervention/treatment Phase
Chronic Lung Disease Drug: Azithromycin Drug: placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease: a Double Blinded RCT
Study Start Date : October 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
Placebo Comparator: placebo
The control group will be provided with a placebo medication of similar taste, color, texture, and consistency as the study medication, and will be dispensed once a day on Monday, Wednesday, and Friday.
Drug: placebo
Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

Experimental: azithromycin
Patients will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will be not be adjusted if a new weight is obtained during the trial period.
Drug: Azithromycin
Patients will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.




Primary Outcome Measures :
  1. Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations) [ Time Frame: 5 to 8 months ]
    Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 5 to 8 months ]
    Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.

  2. Healthcare Cost Associated With Respiratory Illness [ Time Frame: 5 to 8 months ]
    Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.


Other Outcome Measures:
  1. Long Term Reduction in Respiratory Symptoms [ Time Frame: 12 months ]
    To determine if prophylactic use of azithromycin will reduce the total number of unscheduled face-to-face physician visit for respiratory related illness in a clinic, urgent care, emergency room or hospital setting during the following 12 months after the intervention.

  2. Level of Airway Conductance [ Time Frame: 6 months ]
    To determine if prophylactic use of azithromycin will reduce level of airway resistance as measured by an Airwave Oscillometry System in subjects above 2 years of age, at the time of respiratory illnesses, during the 3-6 months intervention.

  3. Level of Cytokines [ Time Frame: 8 months ]
    Using a standardize nasal wash procedure, respiratory samples will be collected at enrollment, at end of study, and during acute respiratory illness requiring face-to-face provider interaction. Children with a tracheostomy will have both a nasal wash sample and a tracheal aspirate sample collected. The respiratory samples will be stabilized with a universal transport media, processed and stored at -80 C for future testing. Testing will be performed for cytokines/chemokines; other biomarkers of disease such as LDH, MPO, and caspase; viral and bacterial respiratory pathogens; and microbiome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with a diagnosis of chronic lung disease (CLD) secondary to bronchopulmonary dysplasia (BPD) as defined by ATS.
  • children who receive primary care at High Risk Infant Clinic or High Risk Children's Clinic

Exclusion Criteria:

  • Children with Cystic Fibrosis or bronchiectasis
  • Children with cardiac arrhythmias
  • Children with cyanotic heart disease
  • Children with colitis
  • Children with a known Macrolide allergy
  • Children taking medications known to interact with macrolides
  • Children with short bowel syndrome
  • Children with kidney or liver failure

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): NCT02544984


Locations
Layout table for location information
United States, Texas
High Risk Children's Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Ricardo A Mosquera, MD University of Texas Medical School in Houston
  Study Documents (Full-Text)

Documents provided by Ricardo A. Mosquera, The University of Texas Health Science Center, Houston:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ricardo A. Mosquera, Associate Professor of Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02544984     History of Changes
Other Study ID Numbers: HSC-MS-14-0476
First Posted: September 9, 2015    Key Record Dates
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018
Last Verified: May 2018
Keywords provided by Ricardo A. Mosquera, The University of Texas Health Science Center, Houston:
prophylactic macrolides
RSV
chronic lung disease
respiratory infections
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents