Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01778634
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2013-01-22
Brief Title:
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase IIb Randomized Placebo-controlled Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZIPIII
Brief Summary:
The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation
Detailed Description:
The study design will be a double-blind placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mgkg x 3 days to eradicate Ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation The primary outcome will be survival with microbiological eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy Secondary outcomes will include physiologic BPD at 36 weeks post-menstrual age PMA overall mortality incidence of co-morbidities of prematurity such as intraventricular hemorrhage periventricular leukomalacia necrotizing enterocolitis bacterial and fungal nosocomial infection pulmonary air leak patent ductus arteriosus retinopathy of prematurity number of days of positive pressure ventilation number of days of oxygen supplementation use of postnatal steroids and use of non-study antibiotics At 6 and 18 months adjusted age a pulmonary outcome questionnaire will be administered by phone or in person interview At 18-22 months adjusted age neurodevelopmental outcomes will be assessed by 1 Bayley Scale of Infant and Toddler Development 3rd edition BSID-III 2 Amiel-Tison neurologic examination 3 Gross Motor Function Classification System and 4 medical record review for hearing impairment with or without amplification and vision impairment vision 20200
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD067126 | NIH | None | httpsreporternihgovquickSearchR01HD067126 |