Refining trichomonas vaginalis treatment in women and men

Active Project Grant Awarded Last action

Award ID
R01AI183266
Recipient
Awarding agency
Obligated
$6,921,713

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 52% complete
Place of performance
New Orleans, LA 70118, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Trichomonas vaginalis is estimated to be the most common non-viral sexually transmitted infection (STI). IT causes considerable and costly perinatal/reproductive morbidity, disproportionately affects persons of color, and can amplify HIV transmission. After our two trials found multi-dose oral metronidazole (MTZ) to be superior to single-dose 2 g oral MTZ, the centers for disease control and prevention now recommends multi-dose MTZ as the treatment of choice for t. Vaginalis in all women. Since neither trial included men and there is a paucity of data in men, single-dose 2 g oral MTZ stands as the recommended treatment for men. In both female trials, however, even though multi-dose oral MTZ was found to be superior to single-dose MTZ, multi- dose MTZ still had unacceptably high rates of breakthrough infection (9%-11%). With approximately 2.6 million cases of t. Vaginalis per year in the united states, over 280,000 persons/year are estimated to be insufficiently treated with multi-dose oral MTZ. Thus, there is a critical need to refine t. Vaginalis treatment. Single-dose 2 g oral secnidazole (SEC), a next generation 5-nitroimidazole, may be a good option. Our recent trial found that single-dose 2 g oral SEC was superior to placebo in t. Vaginalis-infected women. Oral SEC has multiple benefits compared to multi-dose oral MTZ including a longer half-life and improved tolerability. Single-dose SEC poses less burden on the patient and can treat bacterial vaginosis, a common comorbidity among women with t. Vaginalis. On the other hand, MTZ is far less costly and can be given during pregnancy/lactation. The overall goals of this multi-centered, randomized trial are to examine the effectiveness and cost-effectiveness of oral multi-dose MTZ compared to single-dose oral SEC inboth women and men with t. Vaginalis. Aim 1. To examine the optimal treatment for t. Vaginalis infection in women and men. This will be done by conducting an open-label, randomized, multi-centered, parallel phase IV clinical trial comparing oral multi-dose MTZ (500 MG bid for 7 days) to single-dose oral 2 g SEC for the treatment of t. Vaginalis in women and men. The test-of-cure (TOC) visit will be 4 weeks (± 1 week) after completion of treatment. We hypothesize that t. Vaginalis repeat infection rates at TOC will be 1.75 lower in the single-dose 2 g oral SEC arm versus the multi- dose oral MTZ arm. Aim 2 to compare the cost effectiveness of multi-dose oral MTZ versus single-dose oral SEC for the treatment of t. Vaginalis infection. We will compare the direct and indirect costs of treatment using either arm, taking into consideration the reproductive and perinatal outcomes associated with t. Vaginalis infection as well as increased risk for HIV-acquisition. We hypothesize the single-dose SEC will have higher initial cost but will be more cost effective compared to multi-dose MTZ, largely due to lower breakthrough rates. Data from these aims will fill critical gaps in the literature and provide data on refining the treatment of t. Vaginalis among women and men, with the long-term goal of reducing health disparities attributable to this common infection.

Transactions

Action Obligated Date
Amendment Refining trichomonas vaginalis treatment in women and men. - modified project summary/abstract section trichomonas vaginalis is estimated to be the most… $1,381,378
Amendment $1,347,276
Amendment $126,764
Amendment $126,764
Amendment $1,313,177
Amendment $1,313,177
Original award $1,313,177

Subawards

Subrecipient Amount Awarded
Louisiana State University Health Sciences Center New Orleans The contractor shall facilitate the enrollment of 200 participants (women and men) with Trichomonas caginalis gentital infections for randomization into one… $451,464
Womans Hospital Foundation The site PI will serve as co-principle investigator (MPI) to Tulane University MPI on the R01 grant application entitled Refining Trichomonas vaginalis… $109,552
Emory University Emory University will participate in a multi-centered, randomized trial to examine the effectiveness of oral multi-dose metronidazole versus oral single dose… $406,472
Subrecipient not on record The Contractor shall facilitate the enrollment of 400 participants (women and men) with Trichomonas vaginalis genital infections for randomization into one of… $325,153
University Of Alabama At Birmingham Co-principal investigator (MPI) and UAB site PI [at the Jefferson County Health Department (JCDH) Sexual Health Clinic] to Tulane University MPI on the R01… $921,378

Quick answers

Who received award R01AI183266?

R01AI183266 was awarded to The Administrators Of Tulane Educational Fund by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on April 1, 2024.

How much is award R01AI183266 worth?

$6,921,713 has been obligated on R01AI183266.

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