drugset / Trial / NCT01778634
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Phase 2
Completed
121 enrolled
University of Maryland, Baltimore
Christiana Care Health Services · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabJohns Hopkins University · collabMercy Medical Center · collabUniversity of Alabama at Birmingham · collabUniversity of Virginia · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2013-07
- Primary completion
- 2016-12
- Completion
- 2020-11-03
Publications
- Background 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.
- Viscardi RM, Terrin ML, Magder LS, Davis NL, Dulkerian SJ, Waites KB, Ambalavanan N, Kaufman DA, Donohue P, Tuttle DJ, Weitkamp JH, Hassan HE, Eddington ND. Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):615-622. doi: 10.1136/archdischild-2019-318122. Epub 2020 Mar 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 20 mg/kg | Intravenous |