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



Status:Active, not recruiting
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:6/17/2018
Start Date:July 2013
End Date:December 2019

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

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.

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).

Inclusion Criteria:

- 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.
We found this trial at
7
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Baltimore, MD
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, MD
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Nashville, TN
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Newark, Delaware 19713
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Newark, DE
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