Bacteria Infection, Respiratory Tract Infections
Conditions
Keywords
Ureaplasma, Bronchopulmonary dysplasia, very low birthweight
Brief summary
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
Interventions
DRUGAzithromycin
10 mg/kg IV per dose given for 10 days
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No
Inclusion criteria
* Infants weighing \<1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.
Exclusion criteria
* Severe respiratory distress syndrome with survival unlikely \>7 days, Congenital malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 100 days or discharge from hospital | Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy |
| Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 100 days or discharge from hospital | Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first. |
| Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | from day 1 of study drug through 100 days or discharge from hospital, which ever comes first | Number of serious of adverse event experienced by subjects treated with azithromycin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups | from baseline to 100 days or discharge from Hospital, which ever comes first | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Treatment With Azithromycin Azithromycin (10mg/kg/day) start \< 72 hours of age for 10 days | 5 |
| Expectant (Usual) Management Intervention at the discretion of the attending physician | 2 |
| Total | 7 |
Baseline characteristics
| Characteristic | Early Treatment With Azithromycin | Expectant (Usual) Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 5 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 |
Outcome results
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
Time frame: 100 days or discharge from hospital
Population: Unable to determine efficacy due to low enrollment
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.
Time frame: 100 days or discharge from hospital
Population: Unable to determine Pharmacokinetics (PK) data due to low enrollment
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
Time frame: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early Treatment With Azithromycin | Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 0 number of events |
| Expectant (Usual) Management | Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 0 number of events |
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.
Time frame: from baseline to 100 days or discharge from Hospital, which ever comes first
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early Treatment With Azithromycin | Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups | 09.4 days |
| Expectant (Usual) Management | Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups | 2.5 days |