Detailed Research Information

Detailed project information for
Study Plan Number 01125

Branch : Fish Health Branch

Study Plan Number : 01125

Study Title : Modeling Microbial Diversity Of Infection To Affect FDA Revision Of Licensed Antibiotics From “Control Of Mortality” To “Control Of Pathogen”

Starting Date : 12/01/2006

Completion Date : 12/30/2008

Principal Investigator(s) : Cipriano, Rocco C.

Primary PI : Cipriano, Rocco C.

Telephone Number : (304) 724-4432

Email Address : rcipriano@usgs.gov

SIS Number :

Primary Program Element :

Second Program Element :

Status : Active

Abstract : BACKGROUND
Oxytetracycline and Romet®, antibiotics currently used to treat fish diseases within the United States, are licensed by the U.S. Food and Drug Administration (FDA) for “control of mortality.” Thus it is illegal to treat fish before the onset of mortality. The kinetics of bacterial infection suggests that it is possible to disrupt the pattern of contagion by therapeutic intervention before mortality develops. After reviewing such data, representatives from the FDA’s Center for Veterinary Medicine have advised that further studies should be pursued to effect a revision in the status of these drugs from “control of mortality” to “control of pathogen.” This change would allow managers to treat infections before death becomes evident.
OBJECTIVES
The main objectives of this study are to perform controlled studies that will characterize microbial diversity, mimic the kinetics of infection, and develop a reproducible model that will predict the ontogeny of disease based upon perturbations in the microbial flora of dermal mucous. Once the model is developed, such perturbations can be used to assay the efficacy of oxytetracycline as an effective antibiotic for “control of pathogen” rather than “control of mortality,” which would enable prophylactic treatments that preclude disease and mortality. Finally, we shall attempt to correlate shifts in the bacterial distributions (pathogenic and normal) from treated and untreated Atlantic salmon (Salmo salar) with measurements of physiological parameters and clinical chemistry to determine if shifts in microbial populations have a clinical effect on the physiology and stress-related responses of the host.
HYPHOTHESIS TO BE TESTED
We hypothesize that a method of assessing disease progress based on kinetic changes in the microbial diversity of surface bacterial flora can be used (in addition to the obvious reduction or elimination of mortalities) to measure the success of antibiotic treatments under the FDA category of “control of pathogen.”

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Last Modified: October 21, 2002 dwn
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Branch :	Fish Health Branch
Study Plan Number :	01125
Study Title :	Modeling Microbial Diversity Of Infection To Affect FDA Revision Of Licensed Antibiotics From “Control Of Mortality” To “Control Of Pathogen”
Starting Date :	12/01/2006
Completion Date :	12/30/2008
Principal Investigator(s) :	Cipriano, Rocco C.
Primary PI :	Cipriano, Rocco C.
Telephone Number :	(304) 724-4432
Email Address :	rcipriano@usgs.gov
SIS Number :
Primary Program Element :
Second Program Element :
Status :	Active
Abstract :	BACKGROUND Oxytetracycline and Romet®, antibiotics currently used to treat fish diseases within the United States, are licensed by the U.S. Food and Drug Administration (FDA) for “control of mortality.” Thus it is illegal to treat fish before the onset of mortality. The kinetics of bacterial infection suggests that it is possible to disrupt the pattern of contagion by therapeutic intervention before mortality develops. After reviewing such data, representatives from the FDA’s Center for Veterinary Medicine have advised that further studies should be pursued to effect a revision in the status of these drugs from “control of mortality” to “control of pathogen.” This change would allow managers to treat infections before death becomes evident. OBJECTIVES The main objectives of this study are to perform controlled studies that will characterize microbial diversity, mimic the kinetics of infection, and develop a reproducible model that will predict the ontogeny of disease based upon perturbations in the microbial flora of dermal mucous. Once the model is developed, such perturbations can be used to assay the efficacy of oxytetracycline as an effective antibiotic for “control of pathogen” rather than “control of mortality,” which would enable prophylactic treatments that preclude disease and mortality. Finally, we shall attempt to correlate shifts in the bacterial distributions (pathogenic and normal) from treated and untreated Atlantic salmon (Salmo salar) with measurements of physiological parameters and clinical chemistry to determine if shifts in microbial populations have a clinical effect on the physiology and stress-related responses of the host. HYPHOTHESIS TO BE TESTED We hypothesize that a method of assessing disease progress based on kinetic changes in the microbial diversity of surface bacterial flora can be used (in addition to the obvious reduction or elimination of mortalities) to measure the success of antibiotic treatments under the FDA category of “control of pathogen.”
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U.S. Department of the Interior \|\| U.S. Geological Survey 11700 Leetown Road, Kearneysville, WV 25430, USA URL: http://www.lsc.usgs.gov Maintainer: lsc_webmaster@usgs.gov Last Modified: October 21, 2002 dwn Privacy Policy and Disclaimers \|\| FOIA \|\| Accessibility