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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ureaplasma Infections

In brief

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.

Key facts

Study ID

NCT01778634

Run by

University of Maryland, Baltimore

People needed

121

Starts

2013-07-01

Expected to finish

2020-11-03

Last updated by the study team

2020-11-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Christiana Care Health Services — Newark, Delaware, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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