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

• Status: Completed
• Trial end date: 2020-11-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rose Viscardi; University of Maryland, Baltimore
• Collaborators: Christiana Care Health Services; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Johns Hopkins University; Mercy Medical Center; University of Alabama at Birmingham; University of Virginia
• Treatments: Azithromycin

Criteria

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.