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Enrollment was terminated early due to a change in practice on the obstetrical side that included administering azithromycin to women with preterm labor.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Early treatment with azithromycin |
|
| 2 | No Intervention | Expectant (usual) management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 10 mg/kg IV per dose given for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | from day 1 of study drug through 100 days or discharge from hospital, which ever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Schelonka, MD | University of Alabama at Birminham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Treatment With Azithromycin | Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days |
| FG001 | Expectant (Usual) Management | Intervention at the discretion of the attending physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Treatment With Azithromycin | Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days |
| BG001 | Expectant (Usual) Management | Intervention at the discretion of the attending physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Unable to determine efficacy due to low enrollment | Posted | 100 days or discharge from hospital |
|
enrollment through 100 days or discharge which ever is first
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Treatment With Azithromycin | Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days |
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Early termination due to small number enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Randolph | University of Alabama at Birmingham | 205-934-4680 | drandolph@peds.uab.edu |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| from baseline to 100 days or discharge from Hospital, which ever comes first |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | 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. | Posted | Mean | Full Range | days | from baseline to 100 days or discharge from Hospital, which ever comes first |
|
|
|
| Primary | 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. | Unable to determine Pharmacokinetics (PK) data due to low enrollment | Posted | 100 days or discharge from hospital |
|
|
| Primary | Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | Number of serious of adverse event experienced by subjects treated with azithromycin | Posted | Mean | Full Range | number of events | from day 1 of study drug through 100 days or discharge from hospital, which ever comes first |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Expectant (Usual) Management | Intervention at the discretion of the attending physician | 0 | 2 | 0 | 2 |
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| D008171 |
| Lung Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Organic Chemicals |