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 ageDeath 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
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