Novel Triple-dose Tuberculosis Retreatment Regimen
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: 6EH³R³Z, 6EHRZ.
- Кому может быть актуально
- Состояния в реестре: Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs. Базовые параметры: Без ограничений · 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
- Niger
- 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
Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger
Обзор
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).
Подробное описание
Stage 1: This is a pragmatic open-label multi-stage randomized clinical trial. Potential participants will be screened and enrolled in Damien Foundation (DF) clinics participating in the trial.
First we will perform a two-arm study with 6EHRZ as control arm and 6EH³R³Z as intervention arm. If at interim analysis the intervention arm is not considered to be non-inferior to the control arm, the intervention stops and enrolment will continue in a an adapted intervention arm and the control arm (6EHRZ). Otherwise, enrolment continues to 6EHRZ and 6EH³R³Z.
Observational study (stage 2): The DSMB members agreed due to safety concerns to continuing the study as a cohort with only the control arm. The control regimen will remain the same (6EHRZ).
As per routine practice, during treatment patients are in daily contact with the direct observed therapy (DOT) supervisor and minimally monthly clinic visits are scheduled for monitoring of safety and treatment response.
Additionally, liver function tests will be performed at fixed intervals during treatment. Six month and one year after treatment completion or cure the patient will be checked for relapse with systematic sputum acid-fast bacilli (AFB)-microscopy and TB culture.
Вмешательства
- Препарат 6EH³R³Z
A triple dose is defined as the triple of the routine dose used for a specific WHO weight band. Hence, the mg/kg within a weigh-band varies, as is the case in routine practice. Dosing takings into consideration the fixed dose combination (FDC) tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E). Dosage relies on tables with dosage by weight-bands used by WHO for the Cat. 1 regimen. The dosage used for the intensive phase of the Cat. 1 regimen applies for the whole treatment duration. - Препарат 6EHRZ
Recommended normal dose adults (WHO, 2003) * H: 5 (4-6) mg/kg/day * R: 10 (8-12) mg/kg/day * Z: 25 (20-30)mg/kg/day * E: 15 (15-18)mg/kg/day
Первичные конечные точки
- STAGE 1:number of patients with any grade 3-5 Adverse Event (AE) during treatment, assessed as probably or definitely related to TB treatment [Срок оценки: 18 months]
- STAGE 2: Describe bacterial effectiveness [Срок оценки: 18 months]
- STAGE 2: Describe acquired resistance [Срок оценки: 18 months]
Вторичные конечные точки (12)
- STAGE 1: number of previously treated patients with H-monoresistance and H-polyresistance, rifampicin (RMP) resistance missed by Xpert Mycobacterium tuberculosis (MTB)/rifampicin (RIF) [Срок оценки: 18 months]
- STAGE 1: Programmatical effectiveness:number of participants with treatment success divided by number of participants with failure, death, or Lost to follow-up (LTFU) [Срок оценки: 6 months, 18 months]
- STAGE 1: Clinical effectiveness: number of participants with treatment success, divided by number of participants with failure or death [Срок оценки: 6 months, 18 months]
- STAGE 1:Bacteriological effectiveness : number of participants with treatment success, divided by number of participants with failure [Срок оценки: 6 months, 18 months]
- STAGE 2:Bacteriological effectiveness : number of participants with treatment success, divided by number of participants with failure [Срок оценки: 6 months, 18 months]
- STAGE 2: number of participants with acquired resistance, to Isoniazid (INH) and/or RMP [Срок оценки: 6 months, 18 months]
- number of participants with stable (without reversion) SSM conversion [Срок оценки: 2 months]
- STAGE 1: number of participants with drug-induced hepatotoxicity [Срок оценки: 18 months]
- STAGE 1:number of participants with any TB treatment change due to drug-induced hepatoxicity [Срок оценки: 18 months]
- STAGE 1:number of participants with any TB treatment change due to AE [Срок оценки: 18 months]
- STAGE 1:number of participants with any grade 3-5 AE [Срок оценки: 18 months]
- STAGE 1:number of participants with any Serious Adverse Event (SAE) [Срок оценки: 18 months]
Критерии участия
Критерии включения
- All newly registered patients with smear-positive recurrent pulmonary TB
- Adults as well as children (no age limit)
- Able and willing to provide written informed consent
- Added for stage 2: lives within 5 km of a health facility with a medical doctor
Критерии исключения
- All patients with TB initially resistant to rifampicin on Xpert MTB/RIF testing
- Patients transferred to a health facility not supported by the Damien Foundation
- Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period
- Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening
- Pregnant or breastfeeding woman
- HIV co-infected patients requiring treatment with a protease inhibitor
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Niger · 1 центр
- Damien Foundation — Niamey
Идентификаторы
NCT: NCT04260477 · ITM202001