Randomized control trial of nitazoxanide for the treatment of cryptosporidium infection in malnourished children in bangladesh

Active Cooperative Agreement Awarded Last action

Award ID
U01AI167788
Recipient
Awarding agency
Obligated
$3,984,497

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 70% complete
Place of performance
Baltimore, MD 21205, USA

Award details come from USAspending.gov.

Description

Abstract
Cryptosporidiosis is a leading contributor to child morbidity and mortality worldwide, responsible for over 200,000 deaths in children under two, and morbidity in over 7 million children. However, we have limited treatment and no vaccine for use in young children. Our prior work in bangladesh has demonstrated that almost 80% of children in an urban slum cohort were infected with cryptosporidium SPP. By age two and that infection, even without diarrhea, was significantly associated with long-term growth faltering. Nitazoxanide is the only FDA-approved drug for treatment of cryptosporidium diarrheal disease. However, the drug has limited widespread due to lack of large-scale, unbiased rigorous trials demonstrating its efficacy in children under one and establishing its safety in this population. Furthermore, little is known about how the drug could treat non-diarrheal infection and alleviate cryptosporidium's effect on child growth. Here we propose a double-blind, randomized, placebo-controlled trial aimed at treating children ages 6-12 months with cryptosporidium-diarrheal and non-diarrheal infection. The study will evaluate the efficacy of treatment for both conditions and will also evaluate whether treatment can improve growth in children for 6 months post-treatment. This proposal leverages a longstanding collaboration between johns hopkins university and the international centre for diarrhoeal disease, research, bangladesh. This proposal is innovative, as IT will be the first randomized controlled trial aimed at treatment of non-diarrheal cryptosporidium infection and will evaluate impact on growth. The findings from this study will inform treatment efforts aid to protect young children from this devastating infectious disease.

Transactions

Action Obligated Date
Amendment $258,400
Amendment $378,055
Amendment $378,055
Amendment $196,370
Amendment $500,492
Amendment $718,217
Amendment $777,454
Original award $777,454

Subawards

Subrecipient Amount Awarded
International Centre For Diarrhoeal Disease Research, Bangladesh ICDDRB, will be responsible for the conduct of all field work in Dhaka, Bangladesh. Dr. Haque will supervise all the field and lab works and will responsible… $404,670
International Centre For Diarrhoeal Disease Research, Bangladesh $194,032

Quick answers

Who received award U01AI167788?

U01AI167788 was awarded to The Johns Hopkins University by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on May 22, 2023.

How much is award U01AI167788 worth?

$3,984,497 has been obligated on U01AI167788.

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