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

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.

Conditions

• Ureaplasma Infections

Interventions

DRUG

Azithromycin

Azithromycin intravenous 20 mg/kg every 24 h x 3 days

DRUG

Placebo

D5W

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Mercy Medical Center

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Christiana Care Health Services

  collaborator OTHER

• University of Maryland, Baltimore

  lead OTHER

Principal Investigators

• Rose M Viscardi, M.D. · University of Maryland, College Park

• Pamela Donohue, ScD · Johns Hopkins University

• Namasivayam Ambalavanan, M.D. · University of Alabama at Birmingham

• David A Kaufman, M.D. · University of Virginia

• Michael L Terrin, M.D. · University of Maryland, College Park

• Susan J Dulkerian, M.D. · Mercy Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Hours

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2016-12-31

Completion

2020-11-03

Countries

• United States

Study Locations