- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03090334
A B-D-Glucan Driven Antifungal Stewardship Approach for Invasive Candidiasis
A B-D-Glucan Driven Antifungal Stewardship Approach to Manage Empirical Therapy in Patients at Very High Risk for Invasive Candidiasis: a Randomized Controlled Trial
This is a multicenter, prospective, open-label, randomized trial. Patients with severe abdominal condition developing severe sepsis or septic shock and receiving broad spectrum antibiotic and antifungal treatment will be randomized (1:1) to:
- discontinue antifungal treatment based on negative (<80 pg/ml) result of 1,3 beta-d-glucan performed on day 0,3,6 and 10
- continue antifungal treatment according with attending physician's decision.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Primary objective:
Our objective is to establish whether a strategy based on beta-d-glucan (BG) assessment could achieve reduced antifungal consumption in patients with severe abdominal condition developing severe sepsis and septic shock without any impact on the outcome Secondary objectives i) Assess the accuracy of BG in the diagnosis of invasive candidiasis (IC) in in critically ill patients with a severe abdominal condition who develop severe sepsis or septic shock.
ii) Describe the changes over the time of BG value according with colonization status, infection or none the aforementioned events.
Material and Methods Study design: a multicenter, open label, randomized trial Population: all the patients with a severe abdominal condition who develop a severe sepsis or septic shock.
Inclusion Criteria:
- adult (≥ 18 year) patients;
- signed informed consent before surgical procedure;
- severe sepsis or septic shock;
- at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak.
- Exclusion criteria a. diagnosis of candidiasis before the enrollment b. exposure in the past 30 days to any antifungal treatment or diagnosis of invasive fungal infection; c. pregnancy or lactation; d. history of allergy to any of the antifungal drugs; e. major immunosuppression conditions including: i. neutropenia (<0.5 × 109 neutrophils/L [<500 neutrophils/mm3] for >10 days), ii. receipt of an allogeneic stem cell transplant or solid organ transplantation, iii. inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency), iv. HIV infection with lymphocyte T CD4+ cell count < 200/mmc. f. patients with poor prognosis or unable to sign informed consent.
Procedures Pre-randomization procedures
At the time of patient enrollment (within 24 h from onset of severe sepsis/septic shock), a standardized diagnostic work-up must be performed including at least:
i) two sets of blood cultures; ii) 5 surveillance cultures (rectal swab, urine culture, pharyngeal swab, axillary swab, groin swab).
iii) in case of re-intervention or percutaneous drainage: Gram stain and culture of intra-abdominal samples; iv) serum BG determination. Antibiotic and antifungal empirical therapy should be started immediately after collection of microbiological samples according with a predefined standard of care (see appendix 1). Once completed this procedures patients will proceed to randomization.
Randomization Patient eligible for the study after the beginning of antifungal therapy will be randomized 1:1 to receive (Group A) a BG driven de-escalation strategy or (Group B) a course of antifungal treatment based on the care provider's decision.
In both groups, if cultures yield invasive candidiasis (see below) the patient will be managed in according with guidelines and excluded from the per-protocol analysis.
In both groups, BG determination will be repeated at day +3, +6 and +10 after starting antifungal therapy.
Randomization will be carried out providing closed envelopes to the participating centers immediately before the study onset.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Maddalena Giannella, MD, phD
- Telefoonnummer: +39 0512143199
- E-mail: maddalena.giannella@unibo.it
Studie Contact Back-up
- Naam: Michele Bartoletti, MD
- Telefoonnummer: +39 0512143199
- E-mail: michele.bartoletti4@unibo.it
Studie Locaties
-
-
-
Bologna, Italië, 40138
- Werving
- Azienda Ospealiero Universitaria di Bologna Policlinico S.Orsola-Malpighi
-
Contact:
- Maddalena Giannella, MD, PhD
- Telefoonnummer: +39 051 2143199
- E-mail: maddalena.giannella@unibo.it
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- a. adult (≥ 18 year) patients; b. signed informed consent before surgical procedure; c. severe sepsis or septic shock; d. at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak.
Exclusion Criteria:
- a. diagnosis of candidiasis before the enrollment b. exposure in the past 30 days to any antifungal treatment or diagnosis of invasive fungal infection; c. pregnancy or lactation; d. history of allergy to any of the antifungal drugs; e. major immunosuppression conditions including: i. neutropenia (<0.5 × 109 neutrophils/L [<500 neutrophils/mm3] for >10 days), ii. receipt of an allogeneic stem cell transplant or solid organ transplantation, iii. inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency), iv. HIV infection with lymphocyte T CD4+ cell count < 200/mmc. f. patients with poor prognosis or unable to sign informed consent.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: De-escalation
In this group, investigators will manage the antifungal therapy according to the BG levels as follows:
|
Antifungal therapy will be stopped according with BG results
|
Geen tussenkomst: Standard of care
In this group antifungal treatment will be continued until clinician's decision. Investigators will be blinded to the BG levels of patients enrolled in this arm, The BG results will be faxed directly to the coordinating center. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Antifungal consumption
Tijdsspanne: 28 days
|
Days of antifungal consumption will be compared between the two groups
|
28 days
|
Mortality
Tijdsspanne: 28 days
|
28-day mortality will be compared between the two groups
|
28 days
|
Length of stay
Tijdsspanne: 28 days
|
Length of stay in ICU will be compared between the two groups
|
28 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Accuracy of BG
Tijdsspanne: 28 days
|
sensitivity, specificity, positive predictive value, negative predictive value of BG in the diagnosis of invasive candidiasis
|
28 days
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Bassetti M, Marchetti M, Chakrabarti A, Colizza S, Garnacho-Montero J, Kett DH, Munoz P, Cristini F, Andoniadou A, Viale P, Rocca GD, Roilides E, Sganga G, Walsh TJ, Tascini C, Tumbarello M, Menichetti F, Righi E, Eckmann C, Viscoli C, Shorr AF, Leroy O, Petrikos G, De Rosa FG. A research agenda on the management of intra-abdominal candidiasis: results from a consensus of multinational experts. Intensive Care Med. 2013 Dec;39(12):2092-106. doi: 10.1007/s00134-013-3109-3. Epub 2013 Oct 9.
- Kollef M, Micek S, Hampton N, Doherty JA, Kumar A. Septic shock attributed to Candida infection: importance of empiric therapy and source control. Clin Infect Dis. 2012 Jun;54(12):1739-46. doi: 10.1093/cid/cis305. Epub 2012 Mar 15.
- Maubon D, Garnaud C, Calandra T, Sanglard D, Cornet M. Resistance of Candida spp. to antifungal drugs in the ICU: where are we now? Intensive Care Med. 2014 Sep;40(9):1241-55. doi: 10.1007/s00134-014-3404-7. Epub 2014 Aug 5.
- Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BDG-ETHIC
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Invasieve Candidiases
-
University of CologneWerving
-
Medical University of GrazBarmherzige Brueder Marschallgasse / GrazVoltooidInvasieve CandidiasesOostenrijk
-
Services Institute of Medical Sciences, PakistanVoltooid
-
Dr. Santiago PalaciosVoltooidVulvovaginale candidiasesSpanje
-
Cidara Therapeutics Inc.VoltooidMycosen | Candidemie | Schimmelinfectie | Invasieve CandidiasesVerenigde Staten, Israël, Spanje, Korea, republiek van, Taiwan, Singapore, Thailand, Australië, China, Kalkoen, België, Duitsland, Frankrijk, Argentinië, Bulgarije, Colombia, Griekenland, Italië
-
PfizerVoltooidCandidemie | Candida-infectie | Invasieve CandidiasesZuid-Afrika
-
Melbourne HealthMerck Sharp & Dohme LLCWervingSchimmelinfectie | Farmacokinetiek | Invasieve aspergillose | Profylaxe | Invasieve Candidiases | Posaconazol | Invasieve mycoseAustralië
-
Matinas BioPharma Nanotechnologies, Inc.IngetrokkenVulvovaginitis | Candidiasis, vulvovaginaal | Vulvovaginale candidiases | Schimmel infectie | Gistinfectie vaginaalVerenigde Staten
-
Beijing Tsinghua Chang Gung HospitalNog niet aan het werven
Klinische onderzoeken op De-escalation
-
Nektar TherapeuticsBristol-Myers SquibbVoltooidMelanoma | Niercelcarcinoom | Maagkanker | Niet-kleincellige longkanker | Drievoudige negatieve borstkanker | Urotheelcarcinoom | HR+/HER2- BorstkankerVerenigde Staten, Spanje, Canada, Frankrijk, Italië, België, Polen, Verenigd Koninkrijk