Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109525
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2005-04-28
Brief Title:
Early Diagnosis of Candidiasis in Premature Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Early Diagnosis of Nosocomial Candidiasis Study
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Candida
Brief Summary:
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight ELBW infants quickly and accurately 19 NICHD Neonatal Research Network sites enrolled 1500 infants with birth weights 1000g 100 of these infants later tested positive for candidiasis Blood urine and lumbar puncture samples were collected whenever other specimens were obtained from participants for cultures These samples are being tested using the new methods and compared with standard culture results Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age
Detailed Description:
Candida species are a leading cause of infectious mortality in newborns with the incidence rates estimated at 4-18 in extremely low birth weight ELBW infants 20-30 of these infants are likely to die Because candida can invade virtually all body tissues eyes brain heart lung liver spleen urinary tract and joints survivors of invasive Candida infections are at risk of blindness developmental delays and the need for surgical and other corrective procedures
Time is of the essence in detecting and treating these infections with infant mortality from candidiasis largely attributed to duration of time for cultures to become positive for Candida Diagnosis of candidiasis is challenging - blood and urine tests are slow taking up to 72 hours to complete and inaccurate in many cases showing negative results despite overwhelming disease in adults as well as children These problems are likely made worse in neonates with smaller amounts of blood available for testing and infections that often spread to tissues inaccessible for testing
This observational study is evaluating the performance of new lab tests beta-glucan assays Gas Chromatography Mass Spectrometry for D-arabinitol and polymerase chain reaction tests compared to existing culture tests in detecting candida species fungal infections in extremely low birth weight ELBW infants quickly and accurately
In this study 19 NICHD Neonatal Research Network sites enrolled 1500 infants with birth weights 1000g by 72 hours of life more than 100 of these infants later tested positive for candidiasis In the larger cohort whenever cultures of blood or urine were obtained or a lumbar puncture was done additional samples and clinical data were collected These additional samples are being tested using the new techniques under investigation No additional blood specimens were taken once participants had a positive blood culture for candida Note Test procedure reagents are being provided the Duke University laboratory by Cape Cod Incorporated and Rockeby the Thrasher Research Fund is also providing support to the Duke University laboratory
Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age to evaluate potential early risk factors with long-term outcome
Time is of the essence in detecting and treating these infections with infant mortality from candidiasis largely attributed to duration of time for cultures to become positive for Candida Diagnosis of candidiasis is challenging - blood and urine tests are slow taking up to 72 hours to complete and inaccurate in many cases showing negative results despite overwhelming disease in adults as well as children These problems are likely made worse in neonates with smaller amounts of blood available for testing and infections that often spread to tissues inaccessible for testing
This observational study is evaluating the performance of new lab tests beta-glucan assays Gas Chromatography Mass Spectrometry for D-arabinitol and polymerase chain reaction tests compared to existing culture tests in detecting candida species fungal infections in extremely low birth weight ELBW infants quickly and accurately
In this study 19 NICHD Neonatal Research Network sites enrolled 1500 infants with birth weights 1000g by 72 hours of life more than 100 of these infants later tested positive for candidiasis In the larger cohort whenever cultures of blood or urine were obtained or a lumbar puncture was done additional samples and clinical data were collected These additional samples are being tested using the new techniques under investigation No additional blood specimens were taken once participants had a positive blood culture for candida Note Test procedure reagents are being provided the Duke University laboratory by Cape Cod Incorporated and Rockeby the Thrasher Research Fund is also providing support to the Duke University laboratory
Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age to evaluate potential early risk factors with long-term outcome
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 |
|---|---|---|---|
| U10HD053119 | NIH | None | httpsreporternihgovquickSearchU10HD053119 |
| UL1RR024139 | NIH | None | None |
| UL1RR024160 | NIH | None | None |
| M01RR016587 | NIH | None | None |
| M01RR000030 | NIH | None | None |
| M01RR000032 | NIH | None | None |
| M01RR000039 | NIH | None | None |
| M01RR000044 | NIH | None | None |
| M01RR000054 | NIH | None | None |
| M01RR000059 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR007122 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000080 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| U10HD036790 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD040461 | NIH | None | None |
| U10HD040492 | NIH | None | None |
| U10HD040498 | NIH | None | None |
| U10HD040521 | NIH | None | None |
| U10HD040689 | NIH | None | None |
| U10HD053089 | NIH | None | None |
| U10HD053109 | NIH | None | None |