Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cefiderocol susceptibility testing.
- Кому может быть актуально
- Состояния в реестре: Carbapenem-resistant Hypervirulent Klebsiella Pneumoniae Infection. 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
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
1. Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis. 2. Culture: Specimens will be inoculated on MacConkey agar and incubated at 35-37°C for 18-24 hours. Colonies with typical K. pneumoniae morphology (mucoid, lactose-fermenting) will be selected for further testing 3. Identification of isolates will be done by: Colony morphology, Gram staining, and conventional biochemical tests (eg, indole, citrate utilization, urease, Voges-Proskauer) . 4. Antimicrobial susceptibility testing of the isolates : Antimicrobial susceptibility testing was performed and interpreted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines, M100 document (latest edition)." 5. MIC determination for cifederecol using E-test . 6. Phenotypic Detection of hvKP: 1. String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity . 2. Capsule Staining: to visualize large capsules . 3. Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity. 7. Detection of siderophore genes by Simple qualitative PCR .
Подробное описание
Klebsiella pneumoniae ( K.pneumoniae ) is a Gram-negative, encapsulated, non-motile bacterium of the Enterobacteriaceae family and a major pathogen responsible for a broad spectrum of healthcare- and community-acquired infections, including pneumonia, urinary tract infections, bloodstream infections, and pyogenic liver abscesses
1. Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis. 2. Culture: Specimens will be inoculated on MacConkey agar and incubated at 35-37°C for 18-24 hours. Colonies with typical K. pneumoniae morphology (mucoid, lactose-fermenting) will be selected for further testing 3. Identification of isolates will be done by:
Colony morphology, Gram staining, and conventional biochemical tests (eg, indole, citrate utilization, urease, Voges-Proskauer) . 4. Antimicrobial susceptibility testing of the isolates :
Antimicrobial susceptibility testing was performed and interpreted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines, M100 document (latest edition)." 5. MIC determination for cifederecol using E-test . 6. Phenotypic Detection of hvKP:
1. String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity . 2. Capsule Staining: to visualize large capsules . 3. Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity. 7. Detection of siderophore genes by Simple qualitative PCR .
Вмешательства
- Диагностический тест Cefiderocol susceptibility testing
Determination of cefiderocol susceptibility in carbapenem-resistant hypervirulent Klebsiella pneumoniae isolates using antimicrobial susceptibility testing according to CLSI guidelines.
Первичные конечные точки
- Proportion of cefiderocol-susceptible CR-hvKP isolates (%) [Срок оценки: 6 months]
Вторичные конечные точки (2)
- Prevalence of siderophore-associated genes among CR-hvKP isolates (%) [Срок оценки: 6 months]
- Difference in cefiderocol susceptibility rates between siderophore gene-positive and siderophore gene-negative CR-hvKP isolates (%) [Срок оценки: 6 months]
Критерии участия
Критерии включения
\- 1. Patients with hypervirulant K. pneumoniae infection from various clinical specimens (blood, urine, sputum, wound swabs, etc.) Confirmed by culture and initial laboratory testing .
2\. Age and sex range: any age and any sex.
Критерии исключения
\- Patients who received antibiotic treatment in the 48 hours prior to sample collection.
2\. Patients with incomplete clinical data or inadequate samples.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Египет · 1 центр
- Faculty of Medicine — Sohag
Идентификаторы
NCT: NCT07475429 · Soh-Med--25--12-3MS