Negative Beta Glucan in ICU Patients

Перакладаць артыкулы могуць толькі зарэгістраваныя карыстальнікі

Увайсці / Зарэгістравацца

Спасылка захоўваецца ў буферы абмену

СтатусЗавершаны

Спонсары

Universidade Federal do Rio de Janeiro

КЛІНІЧНАЕ ВЫПРАБАВАННЕ: NCT01734525

BioSeek: nct01734525

Ключавыя словы

Рэферат

This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.

Therefore, the objectives of this study are:

1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;

2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Апісанне

Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.

Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.

If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.

Даты

Апошняя праверка:	03/31/2019
Упершыню прадстаўлена:	11/19/2012
Меркаваная колькасць заявак прадстаўлена:	11/25/2012
Першае паведамленне:	11/26/2012
Апошняе абнаўленне адпраўлена:	04/17/2019
Апошняе абнаўленне апублікавана:	07/07/2019
Дата першых прадстаўленых вынікаў:	11/29/2015
Дата першага прадстаўлення вынікаў кантролю якасці:	04/17/2019
Дата вынікаў першага размяшчэння:	07/07/2019
Фактычная дата пачатку даследавання:	10/31/2012
Разліковая дата першаснага завяршэння:	11/30/2013
Разліковая дата завяршэння даследавання:	11/30/2013

Стан альбо хвароба

Candidemia

Ўмяшанне / лячэнне

Drug: Anidulafungin

Фаза

Фаза 4

Групы ўзбраенняў

Рука	Ўмяшанне / лячэнне
Experimental: Anidulafungin Patients at risk will receive therapy with anidulafungin	Drug: Anidulafungin Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Крытэрыі прыдатнасці

Узрост, які мае права на вучобу	18 Years Каб 18 Years
Пол, прыдатны для навучання	All
Прымае здаровых валанцёраў	Так
Крытэрыі	Inclusion Criteria: - In the ICU for >2 days AND - Systemic antibiotics on days 1-3 of ICU OR - Central venous catheter on days 1-3 of ICU - AND at least 2 of: - Total parenteral nutrition on days 1-3 of ICU - Any dialysis on days 1-3 of ICU - Major surgery in the 7 days before admission in the ICU - Pancreatitis in the 7 days before admission in the ICU - Use of corticosteroids for at least 3 days in the 7 days before admission - Use of other immunosuppressive agents in the 7 days before admission in the ICU - In addition, the patient must have at least one of the following: - Fever (axillary temperature >37.5 oC) - Hypothermia (axillary temperature <35 oC) - Hypotension - Unexplained acidosis - Unexplained elevation in C-reactive protein Exclusion Criteria: - Antifungal for >3 days - Allergy to an echinocandin

Вынік

Першасныя вынікі

1. Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin [30 days]

The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin

Negative Beta Glucan in ICU Patients

Ключавыя словы

beta glucan

candidiasis invasive

candidiasis

ліхаманка

гіпатэрмія

панкрэатыт

гіпатанія

acidosis

glucan

1 3 glucan

супрацьгрыбковае

антыбіётыкі

гемадыяліз