Trial · NCT01778634

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

NCT01778634, Phase 2, Completed, University of Maryland, Baltimore; results first posted 2018-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants. Trials, record NCT01778634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01778634

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
NCT number: NCT01778634
Status: Completed
Phases: Phase 2
Enrollment: 121 participants, actual
Lead sponsor: University of Maryland, Baltimore
Conditions: Ureaplasma Infections
Interventions: Azithromycin, Placebo
First posted: 2013-01-29
Last updated: 2020-11-30
Results first posted: 2018-05-17

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks	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).
Secondary	Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age	36 weeks post menstrual age (one month prior to due date)	Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring
Secondary	Number of Participants With Death or Neurodevelopmental Impairment	22-26 months	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.
Secondary	Number of Participants With Pulmonary Impairment	6-26 months	Parent report of recurrent wheezing and/or chronic cough
Secondary	Number of Participants Who Died	22-26 months	Number of Participants who died from any cause
Secondary	Duration of Positive Pressure Support	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks	Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support.
Secondary	Duration of Oxygen Supplementation	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks	Cumulative number of days of receipt of supplemental oxygen
Secondary	Number of Participants Who Experienced Air Leaks	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks	Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray
Secondary	Number of Participants Who Received Postnatal Steroids	36 weeks	Receipt of steroid medications (hydrocortisone, dexamethasone)
Secondary	Number of Participants Who Received Non-Study Antibiotics	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks	Received Non-study antibiotics following study drug intervention period.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age	36 weeks post menstrual age (one month prior to due date)	Participants who survived until assessment timepoint 36 weeks post menstrual age (1 month before due date)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Death or Neurodevelopmental Impairment	22-26 months	Participants who died prior to the 22-26 months assessment timepoint and participants who were assessed for neurodevelopmental impairments	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Pulmonary Impairment	6-26 months	All participants enrolled and randomized in the trial	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Died	22-26 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Positive Pressure Support	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks		days	MEDIAN
SECONDARY	Duration of Oxygen Supplementation	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks		days	MEDIAN
SECONDARY	Number of Participants Who Experienced Air Leaks	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks	The participants who had air leak at baseline (prior to randomization) were excluded from analysis (3 placebo and 5 azithromycin).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Received Postnatal Steroids	36 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Received Non-Study Antibiotics	Participants will be followed for the duration of hospital stay, an expected average of 10 weeks		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group35

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma	Placebo (5% Dextrose)	37	Participants
Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma	Azithromycin	55	Participants
Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age	Placebo (5% Dextrose)	18	Participants
Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age	Azithromycin	25	Participants
Number of Participants With Death or Neurodevelopmental Impairment	Placebo (5% Dextrose)	17	Participants
Number of Participants With Death or Neurodevelopmental Impairment	Azithromycin	25	Participants
Number of Participants With Pulmonary Impairment	Placebo (5% Dextrose)	12	Participants
Number of Participants With Pulmonary Impairment	Azithromycin	15	Participants
Number of Participants Who Died	Placebo (5% Dextrose)	6	Participants
Number of Participants Who Died	Azithromycin	5	Participants

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo (5% Dextrose)	61
Overall Study	STARTED	Azithromycin	60
Overall Study	COMPLETED	Placebo (5% Dextrose)	61
Overall Study	COMPLETED	Azithromycin	60
Overall Study	NOT COMPLETED	Placebo (5% Dextrose)	0
Overall Study	NOT COMPLETED	Azithromycin	0

Source ClinicalTrials.gov

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	IV site reaction	Skin and subcutaneous tissue disorders	Placebo (5% Dextrose)	1	61
other	IV site reaction	Skin and subcutaneous tissue disorders	Azithromycin	0	60
other	Rash	Skin and subcutaneous tissue disorders	Placebo (5% Dextrose)	0	61
other	Rash	Skin and subcutaneous tissue disorders	Azithromycin	1	60
other	Vomiting	Gastrointestinal disorders	Placebo (5% Dextrose)	1	61
other	Vomiting	Gastrointestinal disorders	Azithromycin	1	60
other	Gastric residual >50% volume of feed	Gastrointestinal disorders	Placebo (5% Dextrose)	1	61
other	Gastric residual >50% volume of feed	Gastrointestinal disorders	Azithromycin	3	60
other	Abdominal Distension	Gastrointestinal disorders	Placebo (5% Dextrose)	2	61
other	Abdominal Distension	Gastrointestinal disorders	Azithromycin	3	60

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo (5% Dextrose)	6	61
Total, all-cause mortality	Azithromycin	5	60
Total, other adverse events	Placebo (5% Dextrose)	51	61
Total, other adverse events	Azithromycin	51	60
Total, serious adverse events	Placebo (5% Dextrose)	39	61
Total, serious adverse events	Azithromycin	44	60

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21098694	BACKGROUND	PubMed
32170033	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD067126	Azithromycin To Prevent BPD In Ureaplasma-Infected Preterms	TERRIN, MICHAEL L; DAVIS, NATALIE LOUISE	UNIVERSITY OF MARYLAND BALTIMORE	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2011 to 2019

Source NIH RePORTER

Trial comparisons17

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Azithromycin vs Placebo (5% Dextrose): Number of Participants With Threshold Retinopathy of Prematurity (ROP)	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants Who Experienced Air Leaks	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants With Death or Neurodevelopmental Impairment	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants Who Received Postnatal Steroids	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants With Periventricular Leukomalacia (PVL)	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants With Severe Intraventicular Hemorrhage (IVH)	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants With Cardiac Arrhythmia	Trial comparisons
Azithromycin vs Placebo (5% Dextrose): Number of Participants Who Received Non-Study Antibiotics	Trial comparisons

1 to 10 of 17

See all 17 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01778634

GET https://conductscience.org/api/trials/v1/NCT01778634/results?page=2

API reference For AI assistants