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

NCT02544984 | Completed Results

• 1 other identifier: HSC-MS-14-0476
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Lung Disease

Keywords

prophylactic macrolides; RSV; chronic lung disease; respiratory infections

Outcome Measures

Primary Outcomes (1)

• Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)

  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.

  5 to 8 months

Secondary Outcomes (2)

• Number of Adverse Events

  5 to 8 months

• Healthcare Cost Associated With Respiratory Illness

  5 to 8 months

Other Outcomes (3)

• Long Term Reduction in Respiratory Symptoms

  12 months

• Level of Airway Conductance

  6 months

• Level of Cytokines

  8 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

azithromycin

EXPERIMENTAL

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

Interventions

Azithromycin DRUG

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.

azithromycin

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

High Risk Children's Clinic

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Mosquera RA, Yadav A, Romero-Lopez MDM, Magana-Ceballos IG, Hashmi SS, De Jesus Rojas W, Tellez ME, Riggs-Harpur K, Boricha FM, Reddy TS, John JL, Harris TS, Rodriguez-Martinez CE, Buendia J, McBeth KE, Jon CK, Stark JM, Colasurdo GN. The Effect of Chronic Azithromycin Use in Winter on Health Care Utilization for Children With Bronchopulmonary Dysplasia: A Double Blind Randomized Controlled Study (RCT). Pediatr Pulmonol. 2025 Oct;60(10):e71314. doi: 10.1002/ppul.71314.

  PMID: 41090256 DERIVED

• Mosquera RA, Gomez-Rubio AM, Harris T, Yadav A, McBeth K, Gonzales T, Jon C, Stark J, Avritscher E, Pedroza C, Smith K, Colasurdo G, Wootton S, Piedra P, Tyson JE, Samuels C. Anti-inflammatory effect of prophylactic macrolides on children with chronic lung disease: a protocol for a double-blinded randomised controlled trial. BMJ Open. 2016 Sep 16;6(9):e012060. doi: 10.1136/bmjopen-2016-012060.

  PMID: 27638496 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

Lower than planned sample size.

Results Point of Contact

• Title: Ricardo A. Mosquera, MD
• Organization: The University of Texas Health Science Center at Houston

Ricardo.A.Mosquera@uth.tmc.edu

(713) 500-5650

Study Officials

• Ricardo A Mosquera, MD

  University of Texas Medical School in Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: October 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-05

Locations

US (1)