Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection

Study Overview

• Status: Terminated
• Conditions: Respiratory Tract Infections; Bacteria Infection
• Intervention / Treatment: Drug: Azithromycin

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants weighing <1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.

Exclusion Criteria:

• Severe respiratory distress syndrome with survival unlikely >7 days, Congenital malformations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Early treatment with azithromycin	Drug: Azithromycin; 10 mg/kg IV per dose given for 10 days
No Intervention: 2; Expectant (usual) management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants	Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy	100 days or discharge from hospital
Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants	Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.	100 days or discharge from hospital
Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants	Number of serious of adverse event experienced by subjects treated with azithromycin	from day 1 of study drug through 100 days or discharge from hospital, which ever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups	Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.	from baseline to 100 days or discharge from Hospital, which ever comes first

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Robert L Schelonka, MD, University of Alabama at Birminham

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 10, 2008
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Bronchopulmonary dysplasia; Ureaplasma; very low birthweight
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Body Weight; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Mycoplasmatales Infections; Infections; Communicable Diseases; Birth Weight; Respiratory Tract Infections; Ureaplasma Infections; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: F061228003