Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection
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: PCR multiplex by FilmArray.
- Кому может быть актуально
- Состояния в реестре: Infectious Keratitis, Microbial Keratitis, Corneal Infection. 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
- Франция
- 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
Use of a New Rapid Multiplex PCR System for the Microbiological Diagnosis of Severe Infectious Keratitis: Impact on Therapeutic Management (ABCORFILM Study)
Обзор
Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy. Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea. The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.
Подробное описание
46 patients enrolled for severe infectious keratitis will be recruited in the department of Ophthalmology, Robert Debré Hospital, Reims, France. The study will be composed by 2 groups. The first, also called "before group" will contain 23 patients who were anteriorly hospitalized for a severe infectious keratitis in our hospital unit. They received standard microbiological diagnosis methods: Direct microscopic examination with Gram stain, bacterial and fungal cultures, viral and amoebic polymerase chain reaction \[PCR\]).
The second, also called "after group" will enroll patients who suffer for a severe infectious keratitis (prospective group). Each patient will benefit a complete ophthalmologic examination, corneal scrapping and swabbing for standard microbiological diagnosis methods along with another corneal swabbing sample for the use of two different FilmArray® PCR systems identified as "ME" for Meningitis-Encephalitis and "BCID" for Blood Culture Identification.
The investigators hypothesize that the use of rapid multiplex PCR tests for the microbiological diagnosis of severe corneal infections could in the future prove to be more efficient than the current diagnostic strategy, on the one hand, by shortening the time to identify the pathogen and therefore to implement a targeted treatment, and on the other hand, by systematically searching for a large number of pathogens well beyond those targeted today. In addition, the benefits of this technique applied to ophthalmology could improve the long-term visual prognosis, reduce the length of hospitalization and therefore the diagnostic and management costs of these patients.
Вмешательства
- Биопрепарат PCR multiplex by FilmArray
PCR multiplex by FilmArray system on corneal swabbing sample
Первичные конечные точки
- Time to modification of the first line antimicrobial treatment towards a treatment targeting the detected pathogen. [Срок оценки: At 2 weeks]
Вторичные конечные точки (5)
- Duration of hospitalization [Срок оценки: At 1 month]
- Best corrected visual acuity [Срок оценки: At 12 months]
- Modification of the initial antimicrobial treatment after detection of the etiological agent [Срок оценки: At 1 month]
- Descriptive analysis of pathogens responsible for severe infectious keratitis in Champagne-Ardenne [Срок оценки: At 1 month]
- • Costs of diagnostic methods (conventional and FilmArray) and management (cost of the average length of stay in ophthalmology at the Reims University Hospital for severe infectious keratitis) [Срок оценки: At 1 month]
Критерии участия
Критерии включения
- Over 18 years old
- With social security affiliation
- Willing to participate this study
- Hospitalized in our department for severe infectious keratitis
Non-inclusion criteria:
- Any prior (48 hours) or concomitant treatment with local or systemic antibiotherapy at time of corneal scrapping and swabbing
- Patient not covered by the French Health Insurance
- Unable to give informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Франция · 1 центр
- Damien JOLLY — Reims
Идентификаторы
NCT: NCT05888987 · PA23064