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

NCT ID: NCT01778634

Last Updated: 2020-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2020-11-03

Brief Summary

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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.

Detailed Description

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The study design will be a double-blind, placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate Ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation. The primary outcome will be survival with microbiological eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy. Secondary outcomes will include physiologic BPD at 36 weeks post-menstrual age (PMA), overall mortality, incidence of co-morbidities of prematurity such as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus, retinopathy of prematurity, number of days of positive pressure ventilation, number of days of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. At 6 and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone or in person interview. At 18-22 months adjusted age, neurodevelopmental outcomes will be assessed by 1) Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III); 2) Amiel-Tison neurologic examination; 3) Gross Motor Function Classification System; and 4) medical record review for hearing impairment with or without amplification and vision impairment (vision \<20/200).

Conditions

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Ureaplasma Infections

Keywords

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Ureaplasma parvum Ureaplasma urealyticum prematurity bronchopulmonary dysplasia azithromycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo (5% dextrose)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

D5W

Azithromycin

Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

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

Interventions

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Azithromycin

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

Intervention Type DRUG

Placebo

D5W

Intervention Type DRUG

Other Intervention Names

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Zithromax equal volume of 5% dextrose water

Eligibility Criteria

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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.
Minimum Eligible Age

2 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Mercy Medical Center

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Rose Viscardi

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rose M Viscardi, M.D.

Role: STUDY_CHAIR

University of Maryland, College Park

Pamela Donohue, ScD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Namasivayam Ambalavanan, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

David A Kaufman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Michael L Terrin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Susan J Dulkerian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mercy Medical Center

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Christiana Care Health Services

Newark, Delaware, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21098694 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32170033 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01HD067126

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00054998

Identifier Type: -

Identifier Source: org_study_id