Идёт набор NCT07514364

The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance

Фаза IV С лечением Mycobacterium Abscessus Lung Disease

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: Rifabutin, No Rifabutin.
Кому может быть актуально: Состояния в реестре: Mycobacterium Abscessus Lung Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Тайвань
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

The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study

Обзор

Background: Mycobacterium abscessus, one of the most common species of nontuberculous mycobacterium (NTM), poses a significant clinical challenge due to its natural resistance to antibiotics and high treatment failure rates, particularly in lung diseases. Among its subspecies, M. abscessus subspecies abscessus is especially prone to developing inducible resistance to Clarithromycin. This resistance mechanism is primarily due to the activation of the erm(41) gene,which inhibits Clarithromycin from effectively binding to the bacterial ribosome, diminishing its bactericidal efficacy. Rifabutin, an antibiotic widely used in treating tuberculosis and certain NTM infections, has been shown to inhibit the activation of the erm(41) gene by suppressing the whiB7 protein in M. abscessus, suggesting potential efficacy against inducible resistance. However,current evidence primarily stems from in vitro susceptibility studies and case reports, with a notable lack of systematic clinical trials.

Подробное описание

Specific Aims: The primary aim of this study is to evaluate the efficacy and safety of Rifabutin in treating M. abscessus lung disease with inducible Clarithromycin resistance. Specific objectives include:

* Assessing sputum culture conversion rates and clinical improvement when Rifabutin is added to the standard treatment regimen. * Investigating the effect of Rifabutin on progression-free survival (PFS). * Evaluating patient tolerance and adverse events throughout treatment.

Вмешательства

Препарат Rifabutin
The treatment group (received standard treatment plus Rifabutin, with the dosage adjusted according to weight and renal function)
Препарат No Rifabutin
the control group (received standard treatment only).

Первичные конечные точки

In the study period, we have screened 286 patients with kidney transplant and enrolled 50 participants who were KTR and had LTBI. [Срок оценки: 2years]

Критерии участия

Критерии включения

Adults aged ≥ 18 years
Diagnosis of pulmonary disease caused by Mycobacterium abscessus confirmed by clinical evaluation and laboratory results
Antimicrobial susceptibility testing indicating inducible resistance to clarithromycin
Clinically stable and suitable for antibiotic treatment
Radiographic evidence of active pulmonary infection
Willing and able to provide informed consent