Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011700
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2001-02-26
Brief Title:
Stachybotrys Induced Hemorrhage in the Developing Lung
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-04
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:
None
Brief Summary:
The majority of the workscope of this project is focussed on an infant animal model of toxigenic mold induced pulmonary hemorrhage Clinically related studies are directed only to the description of human infants diagnosed with idiopathic pulmonary hemorrhage regarding their clinical parameters and collecting samples of secretion blood and urine for analysis for fungal spores and mycotoxins These latter analyses are being developed using the infant rat model
Detailed Description:
Over the past seven years in the Cleveland Ohio area there have been 47 cases of unexplained pulmonary hemorrhage in young infants Sixteen of the infants have died A CDC case-control study found an association with water-damaged homes and the toxigenic fungus Stachybotrys chartarum which requires water soaked cellulose to grow The spores of this fungus are not infectious in the lung but do contain very potent mycotoxins which appear to be particularly toxic to the rapidly developing lungs of young infants Secondary stresses eg environmental tobacco smoke appear to be important triggers of overt hemorrhage Concern that there may be a larger number of undetected young infants with this disorder led to the examination of all infant coroner cases which revealed six sudden infant death syndrome cases with major amounts of pulmonary hemosiderin-laden macrophages indicating extensive hemosiderosis existing prior to death All of these infants had lived in the eight zip code area where all but fifteen of the patients have lived This disorder may extend beyond Cleveland since toxigenic fungi are widespread We are aware of a total of 138 infants with idiopathic pulmonary hemorrhage across the country over the past four years
The purpose of this proposal is to establish an infant animal model for this stachybotryomycotoxicosis which can be used to understand the developmental pathophysiology by which the fungal spores induce hemorrhage and to address practical problems faced in the clinical care of these infants and in public health prevention The model uses tracheal instillation of toxic Stachybotrys spores in neonatal to weanling rats to initiate the pathological process followed by stresses to trigger acute hemorrhage Capillary fragility to transmural pressures will be assessed by morphometric analysis of electron micrographs Markers of Stachybotrys exposure which can be applied to clinical cases are being developed and tested in the rats
The purpose of this proposal is to establish an infant animal model for this stachybotryomycotoxicosis which can be used to understand the developmental pathophysiology by which the fungal spores induce hemorrhage and to address practical problems faced in the clinical care of these infants and in public health prevention The model uses tracheal instillation of toxic Stachybotrys spores in neonatal to weanling rats to initiate the pathological process followed by stresses to trigger acute hemorrhage Capillary fragility to transmural pressures will be assessed by morphometric analysis of electron micrographs Markers of Stachybotrys exposure which can be applied to clinical cases are being developed and tested in the rats
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