Phase 2
Completed N=121
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Ureaplasma Infections
Source: ClinicalTrials.gov NCT01778634 ↗
Enrolled (actual)
121
Serious AEs
68.6%
Results posted
May 2018
Primary outcomePrimary: Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma — 37; 55 Participants — p=<0.0001
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.
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 | — |
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.
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. Informational only — not medical advice.