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Liver cystic echinococcosis: pre-clinical assessment of a novel, single step percutaneous treatment procedure (intracystic albendazole sulfoxide injection)

Award Number: R01AI116470
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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¿ DESCRIPTION (provided by applicant): Cystic echinococcosis (CE), a zoonotic disease caused by the larval stage of the dog tapeworm Echinococcus granulosus, is endemic to areas where livestock are raised including Eurasia, UK, Australia, South America and North and East Africa, and considered a serious and costly public health problem in endemic regions. Liver CE is the most common clinical presentation, representing around 70% of human CE cases. Treatment procedures for liver CE have evolved over the past four decades. Currently, four treatment modalities are used: (1) medical treatment with albendazole (ABZ), (2) PAIR (Puncture, Aspiration, Injection of protoscolicidal agent; Reaspiration), (3) surgery to remove the cyst and (4) watch and wait for inactive, clinically silent cysts. In most endemic countries, surgery is the main treatment approach for liver cysts. PAIR has gained ground in the treatment of liver CE and can be performed in centers with limited resources as much as ultrasound guiding is available. PAIR however has some technical drawbacks that include the need to rule out the presence of a cysto-biliary fistula, and is not completely efficacious. A simpler, safer an more effective treatment approach would be of great benefit for patients in endemic regions. The current proposal will evaluate a new treatment approach that consists on a single step injection of albendazole sulfoxide (ABZ-SF), the active metabolite of ABZ, into the cyst. This procedure is less resource and time demanding than PAIR, should not be hampered by the presence of cysto-biliary fistula, and should also be safer than oral ABZ therapy since it avoids the systemic toxicity associated with a prolonged therapy with oral ABZ. The first project is a pilot placebo controlled experimental / interventional animal safety study comparing two different doses of ABZ-SF to determine the higher safe doses as well as to provide preliminary information about efficacy of the antiparasitic drug injection. The second study is a blind, placebo controlled randomized trial testing the highest safe dose of ABZ-SF identified in study 1. Finally, in a third study, which is also a blind, controlled randomized trial, we will determine the minimal needed concentration of intracystic ABZ-SF to achieve treatment success. This proposal can eventually provide a new therapeutic approach for human liver CE, and should result in an R34 application for a future human trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AVENIDA HONORIO DELGADO 430 URB URB INGENIERIA	LIMA				PER	Allergy and Infectious Diseases Research	000	5	6/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $135,000 )
2020	2020	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430	LIMA	LIMA	15102		PER	Allergy and Infectious Diseases Research	000	5	2/24/2020	NON-COMPETING CONTINUATION	$135,000
														Subtotal = $135,000

Issue Date FY: 2019 ( Subtotal = $135,000 )
2019	2019	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Allergy and Infectious Diseases Research	000	4	2/8/2019	NON-COMPETING CONTINUATION	$135,000
														Subtotal = $135,000

Issue Date FY: 2018 ( Subtotal = $135,000 )
2018	2018	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Allergy and Infectious Diseases Research	000	3	2/23/2018	NON-COMPETING CONTINUATION	$135,000
														Subtotal = $135,000

Issue Date FY: 2017 ( Subtotal = $135,000 )
2017	2017	UNIVERSIDAD PERUANA CAYETANO HEREDIA	AV. HONORIO DELGADO 430 URB. INGENIERIA	LIMA		31		PER	Allergy and Infectious Diseases Research	000	2	2/15/2017	NON-COMPETING CONTINUATION	$135,000
														Subtotal = $135,000

Issue Date FY: 2016 ( Subtotal = $135,000 )
2016	2016	UNIVERSIDAD PERUANA CAYETANO	Av Honorio Delgado 430, Urb Ingenie	LIMA				PER	Allergy and Infectious Diseases Research	000	1	3/4/2016	NEW	$135,000
														Subtotal = $135,000

Grand Total All Awards = $675,000

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Liver cystic echinococcosis: pre-clinical assessment of a novel, single step percutaneous treatment procedure (intracystic albendazole sulfoxide injection)

Award Number: R01AI116470

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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