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

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ureaplasma Infections

Intervention: Azithromycin (Drug); Placebo (for azithromycin) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Rose Viscardi

Official(s) and/or principal investigator(s):
Rose M Viscardi, M.D., Study Chair, Affiliation: University of Maryland
Pamela Donohue, ScD, Principal Investigator, Affiliation: Johns Hopkins University
Namasivayam Ambalavanan, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham
David A Kaufman, M.D., Principal Investigator, Affiliation: University of Virginia
Michael L Terrin, M.D., Principal Investigator, Affiliation: University of Maryland
Susan J Dulkerian, M.D., Principal Investigator, Affiliation: Mercy Medical Center

Overall contact:
Rose M Viscardi, M.D., Phone: 410-706-1913, Email: rviscard@umaryland.edu

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.

Clinical Details

Official title: A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Survival with microbiological eradication of Ureaplasma

Secondary outcome:

Physiologic defined bronchopulmonary dysplasia (BPD) at 36 weeks post menstrual age

Death or Neurodevelopmental impairment

Pulmonary impairment

Death

Duration of positive pressure support

Duration of oxygen supplementation

Air leaks

Received postnatal steroids

Received Non-Study antibiotics

Pharmacokinetics (PK)/Pharmacodynamics (PD) modelling of time course of azithromycin plasma concentrations

Detailed description: The study design will be a double-blind, placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate Ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation. The primary outcome will be survival with microbiological eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy. Secondary outcomes will include physiologic BPD at 36 weeks post-menstrual age (PMA), overall mortality, incidence of co-morbidities of prematurity such as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus, retinopathy of prematurity, number of days of positive pressure ventilation, number of days of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. At 6 and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone or in person interview. At 18-22 months adjusted age, neurodevelopmental outcomes will be assessed by 1) Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III); 2) Amiel-Tison neurologic examination; 3) Gross Motor Function Classification System; and 4) medical record review for hearing impairment with or without amplification and vision impairment (vision <20/200).

Eligibility

Minimum age: N/A. Maximum age: 72 Hours. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Appropriate size for gestational age (AGA)

- 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

Exclusion Criteria:

- 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.

Locations and Contacts

Rose M Viscardi, M.D., Phone: 410-706-1913, Email: rviscard@umaryland.edu

University of Alabama at Birmingham, Birmingham, Alabama 35249-7335, United States; Recruiting
Namasivayam Ambalavanan, M.D., Principal Investigator

Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Pamela Donohue, ScD, Phone: 410-955-5232, Email: pdonohue@jhmi.edu
Susan Aucott, MD, Sub-Investigator
Pamela Donohue, ScD, Principal Investigator

Mercy Medical Center, Baltimore, Maryland 21202, United States; Recruiting
Susan J Dulkerian, MD, Phone: 410-332-9594, Email: sdulkerian@mdmercy.com

University of Maryland School of Medicine, Baltimore, Maryland 21201, United States; Recruiting
Rose M Viscardi, MD, Principal Investigator
Michael L Terrin, M.D., Sub-Investigator
Laurence S Magder, PhD, Sub-Investigator

University of Virginia, Charlottesville, Virginia 22908-0386, United States; Recruiting
David Kaufman, MD
David A Kaufman, M.D., Principal Investigator

Additional Information

Related publications:

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.

Starting date: July 2013
Last updated: May 28, 2015

Page last updated: August 23, 2015

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