Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

NCT01778634 | Completed Phase 2 Results DMC

• 2 other identifiers: HP-00054998R01HD067126
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.

Conditions

Ureaplasma Infections

Keywords

Ureaplasma parvum; Ureaplasma urealyticum; prematurity; bronchopulmonary dysplasia; azithromycin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma

  Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).

  Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

Secondary Outcomes (10)

• Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age

  36 weeks post menstrual age (one month prior to due date)

• Number of Participants With Death or Neurodevelopmental Impairment

  22-26 months

• Number of Participants With Pulmonary Impairment

  6-26 months

• Number of Participants Who Died

  22-26 months

• Duration of Positive Pressure Support

  Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

Other Outcomes (7)

• Number of Participants With Threshold Retinopathy of Prematurity (ROP)

  Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

• Number of Participants With Necrotizing Enterocolitis (NEC)

  Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

• Number of Participants With Infections During the NICU Hospitalization

  Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

Study Arms (2)

Placebo (5% dextrose)

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Azithromycin

EXPERIMENTAL

Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days

Drug: Azithromycin

Interventions

Azithromycin DRUG

Azithromycin intravenous 20 mg/kg every 24 h x 3 days

Also known as: Zithromax

Azithromycin

Placebo DRUG

D5W

Also known as: equal volume of 5% dextrose water

Placebo (5% dextrose)

Eligibility Criteria

• Age: 2 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate
• \<72 h age
• Positive pressure ventilation for at least 1 hour duration during the first 72 hours of life
• Presence of indwelling intravenous line for drug administration

You may not qualify if:

• Any patient judged to be non-viable or for whom withdrawal of life support is planned
• Patients with major lethal congenital anomalies
• Triplets or higher order multiples
• Patients delivered for maternal indications (low risk of Ureaplasma colonization)
• Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms
• Patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL)
• Patients exposed to other systemic macrolide
• Patients with clinically suspected Ureaplasma central nervous system (CNS) infection or other confirmed bacterial/viral infection
• Patients participating in other clinical trials involving investigational products.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Mercy Medical Center: collaborator
• Johns Hopkins University: collaborator
• University of Virginia: collaborator
• University of Alabama at Birmingham: collaborator
• Christiana Care Health Services: collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35249-7335, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232-9544, United States

Location

University of Virginia

Charlottesville, Virginia, 22908-0386, United States

Location

Related Publications (2)

• Hassan HE, Othman AA, Eddington ND, Duffy L, Xiao L, Waites KB, Kaufman DA, Fairchild KD, Terrin ML, Viscardi RM. Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia. J Clin Pharmacol. 2011 Sep;51(9):1264-75. doi: 10.1177/0091270010382021. Epub 2010 Nov 23.

  PMID: 21098694 BACKGROUND

• Viscardi RM, Terrin ML, Magder LS, Davis NL, Dulkerian SJ, Waites KB, Ambalavanan N, Kaufman DA, Donohue P, Tuttle DJ, Weitkamp JH, Hassan HE, Eddington ND. Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):615-622. doi: 10.1136/archdischild-2019-318122. Epub 2020 Mar 13.

  PMID: 32170033 DERIVED

MeSH Terms

Conditions

Ureaplasma Infections; Premature Birth; Bronchopulmonary Dysplasia

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Rose Marie Viscardi, M.D.
• Organization: University of Maryland

rviscard@som.umaryland.edu

410-706-1913

Study Officials

• Rose M Viscardi, M.D.

  University of Maryland, College Park

  STUDY CHAIR

• Pamela Donohue, ScD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Namasivayam Ambalavanan, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• David A Kaufman, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Michael L Terrin, M.D.

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Susan J Dulkerian, M.D.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 29, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: November 3, 2020
• Last Updated: November 30, 2020
• Results First Posted: May 17, 2018

Record last verified: 2020-11

Locations

US (7)