A Phase 1/2 interventional study of Azithromycin in Bacteria Infection and Respiratory Tract Infections, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 1 Day to 3 Days. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Prevention
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 7 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Early treatment with azithromycin
Drug: Azithromycin
Expectant (usual) management
10 mg/kg IV per dose given for 10 days
Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy
Time frame: 100 days or discharge from hospital
Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.
Time frame: 100 days or discharge from hospital
Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Number of serious of adverse event experienced by subjects treated with azithromycin
Time frame: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first
Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups
Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.
Time frame: from baseline to 100 days or discharge from Hospital, which ever comes first
| Milestone | Early Treatment With Azithromycin | Expectant (Usual) Management |
|---|---|---|
| Started | 5 | 2 |
| Completed | 5 | 2 |
| Not completed | 0 | 0 |
Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy
No measurements were reported for this outcome.
Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.
| days | Early Treatment With Azithromycin | Expectant (Usual) Management |
|---|---|---|
| Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups | 09.4 (0 to 23) | 2.5 (0 to 5) |
Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.
No measurements were reported for this outcome.
Number of serious of adverse event experienced by subjects treated with azithromycin
| number of events | Early Treatment With Azithromycin | Expectant (Usual) Management |
|---|---|---|
| Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 0 (0 to 0) | 0 (0 to 0) |
Collected over enrollment through 100 days or discharge which ever is first. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Treatment With Azithromycin | — | 0/5 (0%) | 0/5 (0%) |
| Expectant (Usual) Management | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Early Treatment With Azithromycin | Expectant (Usual) Management | Total |
|---|---|---|---|
| <=18 years | 5 | 2 | 7 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Early Treatment With Azithromycin | Expectant (Usual) Management | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 2 | 0 | 2 |
| Region of Enrollment(participants) | Early Treatment With Azithromycin | Expectant (Usual) Management | Total |
|---|---|---|---|
| United States | 5 | 2 | 7 |
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham