Идёт набор NCT07088419

"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"

Фаза II С лечением Mycoplasma Genitalium Non-gonococcal Urethritis (NGU)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tinidazole.
Кому может быть актуально: Состояния в реестре: Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU). Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic

Обзор

The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Tinidazole was approved by the Food and Drug Administration (FDA) in May 2004 to treat other infections (i.e., trichomoniasis, giardiasis, amebiasis, bacterial vaginosis) but has not been systematically tested for effectiveness against M. genitalium. The dosing that the investigators are proposing does not significantly increase the risk associated with taking tinidazole and this investigation meets criteria for an IND exemption.

Подробное описание

To estimate the efficacy of tinidazole for treating M. genitalium among people male sex at birth (men) diagnosed with NGU, the investigators will enroll men with NGU attending an urban sexual health clinic who have a positive test for M. genitalium. Prior to enrollment, men with NGU will have received syndromic therapy for NGU consisting of doxycycline 100mg orally twice daily for 7 days. After enrollment men with NGU will receive tinidazole 2 grams orally on day one followed by 500mg orally twice daily on days 2-10. Participants will undergo a test of cure 21 days after completing the tinidazole regimen to determine whether M. genitalium has been eradicated (microbiologic cure). Remnant urine specimens from the NGU diagnosis visit will be used to perform culture and minimum inhibitory concentration (MIC) assessment, and will undergo quantitative PCR (qPCR) to determine initial organism load. Urine specimens collected at the initiation of tinidazole therapy and at the test of cure will also undergo culture, MIC assessment, and qPCR .

Вмешательства

Препарат Tinidazole
2 grams orally on day one followed by 500mg orally twice daily on days 2-10

Первичные конечные точки

Microbiologic cure of M. genitalium [Срок оценки: Day 38]

Вторичные конечные точки (4)

Antimicrobial susceptibility to tinidazole (MIC levels) [Срок оценки: baseline; day 7; day 38]
Antimicrobial susceptibility to tinidazole (resistance associated mutations) [Срок оценки: baseline; day 7; day 38]
Association of high MIC levels with treatment failure [Срок оценки: Day 38]
Association of tinidazole resistance-associated mutations with treatment failure [Срок оценки: Day 38]

Критерии участия

Критерии включения

≥18 years of age
Clinical diagnosis of NGU
Urogenital MG documented by a positive NAAT in the prior 7 days
Fluent in English
Assigned male at birth
Attending the PHSKC SHC
Able to provide informed consent
Able to undergo a test of cure (TOC) 21 days after completing the tinidazole regimen