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AzTrials

Ureaplasma InfectionsPhase 2AZIPIIINCT01778634

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

A Phase 2 study testing Azithromycin in people with Ureaplasma Infections, run by University of Maryland, Baltimore at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 72 hours
Conditions the study is for
Ureaplasma Infections
What is being tested?
Azithromycin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
7 sitesUnited States
Study dates
Jul 2013to 3 Nov 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 72 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249-7335

  • University of Virginia

    Charlottesville, Virginia, 22908-0386

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232-9544

  • Christiana Care Health Services

    Newark, Delaware, 19713

Other trials in United States

About this study

Official title: A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

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.

Read the detailed description

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).

Being tested
Azithromycin, Placebo
Keywords
Ureaplasma parvum, Ureaplasma urealyticum, prematurity, bronchopulmonary dysplasia, azithromycin
Medical subject headings
Ureaplasma Infections, Premature Birth, Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    Also called Zithromax

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

  • PlaceboDrug

    Also called equal volume of 5% dextrose water

    D5W

Study groups in NCT01778634
Study groupRoleWhat they receive
Placebo (5% dextrose)Placebo comparatorPlacebo
Receives: Drug: Placebo
AzithromycinExperimentalAzithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days
Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma

    Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

Secondary outcomes (10)

  1. Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age

    Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring

    Measured: 36 weeks post menstrual age (one month prior to due date)

  2. Number of Participants With Death or Neurodevelopmental Impairment

    Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score <70.

    Measured: 22-26 months

  3. Number of Participants With Pulmonary Impairment

    Parent report of recurrent wheezing and/or chronic cough

    Measured: 6-26 months

  4. Number of Participants Who Died

    Number of Participants who died from any cause

    Measured: 22-26 months

  5. Duration of Positive Pressure Support

    Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  6. Duration of Oxygen Supplementation

    Cumulative number of days of receipt of supplemental oxygen

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  7. Number of Participants Who Experienced Air Leaks

    Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  8. Number of Participants Who Received Postnatal Steroids

    Receipt of steroid medications (hydrocortisone, dexamethasone)

    Measured: 36 weeks

  9. Number of Participants Who Received Non-Study Antibiotics

    Received Non-study antibiotics following study drug intervention period.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks

  10. Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations

    Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants.

    Measured: Study day 1-day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2016
  4. Study completion3 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01778634
Sponsor's protocol ID
HP-00054998
Other IDs
R01HD067126
Acronym
AZIPIII
Status last verified
Nov 2020
First submitted
22 Jan 2013
Last updated
30 Nov 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21098694

  • 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.

    PubMed 32170033

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azithromycin in people with Ureaplasma Infections, run by University of Maryland, Baltimore at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma (time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01778634, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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