Идёт набор NCT05733104

A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea

— Наблюдательное Complicated Intra-abdominal Infection Complicated Urinary Tract Infection Hospital-acquired Pneumonia

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia. Базовые параметры: от 3 мес. · 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: South Korea
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

Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV

Обзор

The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen, urinary tract and pneumonia which could have come from hospitalizations. This study was required by the Ministry of Food and Drug Safety (MFDS) of Korea's regulations.

Подробное описание

The objective of this study is to determine any problems or questions associated with Zavicefta after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".

1. Serious adverse event/adverse drug reaction 2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label. 3. Known adverse drug reaction 4. Non-serious adverse drug reaction 5. Other safety and effectiveness information As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. This reserach shall begin after approval of marketing in Korea by MFDS.

Первичные конечные точки

Number of patient reporting an adverse event [Срок оценки: From first dose to end of the observation period (at least 28 calendar days following the last dose)]

Вторичные конечные точки (1)

Clinical response: Number of patient recorded as cure [Срок оценки: up to one year]

Критерии участия

Adults and paediatric patients aged 3 months and older, who have been administered at least one dose of Zavicefta for the treatment of one of the indications as follows:

Complicated intra-abdominal infection (cIAI)
Complicated urinary tract infection (cUTI), including pyelonephritis
Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
Other aerobic Gram-negative organism infection with limited treatment options
Adults 19 years of age or older, who have been administered at least one dose of Zavicefta for the treatment of the indication as follows:

•Bacteremia associated with or suspected to be associated with cIAI, cUTI or HAP including VAP.