Phase 2 N=121 Randomized Quadruple-blind Treatment

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

Ureaplasma Infections

Bottom Line

View on ClinicalTrials.gov: NCT01778634 ↗

Enrolled (actual)

121

Serious AEs

68.6%

Results posted

May 2018

Primary outcome: Primary: Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma — 37; 55 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Azithromycin (Drug); Placebo (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma	37; 55	<0.0001 sig
SECONDARY Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age	18; 25	0.28
SECONDARY Number of Participants With Death or Neurodevelopmental Impairment	17; 25	0.11
SECONDARY Number of Participants With Pulmonary Impairment	12; 15	0.62
SECONDARY Number of Participants Who Died	6; 5	1.0
SECONDARY Duration of Positive Pressure Support	36; 39	0.88
SECONDARY Duration of Oxygen Supplementation	68; 73	0.94
SECONDARY Number of Participants Who Experienced Air Leaks	4; 7	0.49
SECONDARY Number of Participants Who Received Postnatal Steroids	14; 15	0.88
SECONDARY Number of Participants Who Received Non-Study Antibiotics	14; 8	0.18
SECONDARY Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations	4	—

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.

Eligibility Criteria

Inclusion Criteria

Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01778634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.