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| Sponsored by: |
University of Alabama at Birmingham |
|---|---|
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00599053 |
Purpose
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 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
| Condition | Intervention | Phase |
|---|---|---|
|
Bacteria Infection Respiratory Tract Infections |
Drug: Azithromycin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates |
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Early treatment with azithromycin
|
Drug: Azithromycin
10 mg/kg IV per dose given for 10 days
|
|
2: No Intervention
Expectant (usual) management
|
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert L Schelonka, MD | 205-934-6450 | rschelon@uab.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Robert L Schelonka, MD 205-823-9979 rschelon@uab.edu | |
| Principal Investigator: Robert L Schelonka, MD | |
| Principal Investigator: | Robert L Schelonka, MD | University of Alabama at Birminham |
More Information
| Responsible Party: | University of Alabama at Birmingham ( Robert L. Schelonka, MD-Principal Investigator ) |
| Study ID Numbers: | F061228003 |
| Study First Received: | January 10, 2008 |
| Last Updated: | January 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00599053 |
| Health Authority: | United States: Institutional Review Board |
|
Ureaplasma Bronchopulmonary dysplasia very low birthweight |
|
Bronchopulmonary dysplasia Bacterial Infections Body Weight Birth Weight Bronchopulmonary Dysplasia Signs and Symptoms |
Respiratory Tract Diseases Respiratory Tract Infections Azithromycin Ureaplasma Infections Gram-Negative Bacterial Infections |
|
Mycoplasmatales Infections Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |
