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

NCT00599053 | Terminated Phase 1 Results DMC

• 1 other identifier: F061228003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bacteria Infection; Respiratory Tract Infections

Keywords

Ureaplasma; Bronchopulmonary dysplasia; very low birthweight

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups

  from baseline to 100 days or discharge from Hospital, which ever comes first

Study Arms (2)

1

EXPERIMENTAL

Early treatment with azithromycin

Drug: Azithromycin

2

NO INTERVENTION

Expectant (usual) management

Interventions

Azithromycin DRUG

10 mg/kg IV per dose given for 10 days

1

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Bronchopulmonary Dysplasia

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

Early termination due to small number enrolled.

Results Point of Contact

• Title: Dr. David Randolph
• Organization: University of Alabama at Birmingham

drandolph@peds.uab.edu

205-934-4680

Study Officials

• Robert L Schelonka, MD

  University of Alabama at Birminham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 23, 2008
• Study Start: May 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 17, 2017
• Results First Posted: December 31, 2012

Record last verified: 2017-04

Locations

US (1)