Trial · NCT00599053
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
NCT00599053, Phase 1, Phase 2, Terminated, University of Alabama at Birmingham; results first posted 2012-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates. Trials, record NCT00599053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00599053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
- NCT number
- NCT00599053
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Bacteria Infection, Respiratory Tract Infections
- Interventions
- Azithromycin
- First posted
- 2008-01-23
- Last updated
- 2017-05-17
- Results first posted
- 2012-12-31
- Limitations and caveats
- Early termination due to small number enrolled.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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. |
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 100 days or discharge from hospital | Unable to determine efficacy due to low enrollment | ||
| SECONDARY | 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 | days | MEAN | |
| PRIMARY | Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | 100 days or discharge from hospital | Unable to determine Pharmacokinetics (PK) data due to low enrollment | ||
| PRIMARY | 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 events | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups | Early Treatment With Azithromycin | 09.4 | Full Range 0 to 23 | days | |
| Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups | Expectant (Usual) Management | 2.5 | Full Range 0 to 5 | days | |
| Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | Early Treatment With Azithromycin | 0 | Full Range 0 to 0 | number of events | |
| Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | Expectant (Usual) Management | 0 | Full Range 0 to 0 | number of events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early Treatment With Azithromycin | 5 | |
| Overall Study | STARTED | Expectant (Usual) Management | 2 | |
| Overall Study | COMPLETED | Early Treatment With Azithromycin | 5 | |
| Overall Study | COMPLETED | Expectant (Usual) Management | 2 | |
| Overall Study | NOT COMPLETED | Early Treatment With Azithromycin | 0 | |
| Overall Study | NOT COMPLETED | Expectant (Usual) Management | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early Treatment With Azithromycin | ||
| Total, all-cause mortality | Expectant (Usual) Management | ||
| Total, other adverse events | Early Treatment With Azithromycin | 0 | 5 |
| Total, other adverse events | Expectant (Usual) Management | 0 | 2 |
| Total, serious adverse events | Early Treatment With Azithromycin | 0 | 5 |
| Total, serious adverse events | Expectant (Usual) Management | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Early Treatment With Azithromycin vs Expectant (Usual) Management: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00599053
GET https://conductscience.org/api/trials/v1/NCT00599053/registered