An interventional study of De-escalation in Invasive Candidiases and Abdominal Infection, sponsored by University of Bologna. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by University of Bologna · Not applicable, Interventional, and Other
Among 14 studies in Candidiasis, Invasive with a site in Italy — 1 open to participants now, 1 under way, 1 of them phase 3. Candidiasis, Invasive · Italy.
Among the 14 studies in Candidiasis, Invasive with a site in Italy, this one is the 11th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2017, is the only one with no phase, and was the 7th registered.
65 studies on the registry are indexed under Candidiasis, Invasive; 6 are open to participants now.
Browse Candidiasis, Invasive studies →1 of the 14 studies in Candidiasis, Invasive with a site in Italy is open now. Recruiting first, the newest first:
Basilea Pharmaceutica · Sites in Italy, United States, Argentina and 17 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 5 Candidiasis, Invasive studies recruiting now, 5 set no upper age limit and none stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 34 is below the median of 60 across 47 interventional studies indexed under Candidiasis, Invasive.
Median enrollment 70 across the 13 interventional studies, 0 across the 1 observational. Of the 12 that completed or were terminated, 7 (58%) have results posted.
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11 of 14 have an industry lead sponsor. The 10 most frequent:
University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
University of Bologna has 1 study filed under Candidiasis, Invasive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Candidiasis, Invasive with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, investigators will manage the antifungal therapy according to the BG levels as follows: 1. antifungal therapy will be stopped immediately after the BG response in case of serum BG \<80 pg/ml in presence of clinical stability (CS); 2. antifungal therapy will be continued until further BG determination, both for BG levels between 80-200 pg/ml and for BG \<80 pg/ml in patients without CS. In these cases, if the following BG value is \<80 pg/ml antifungal therapy will be stopped independently from the CS achievement. 3. antifungal therapy will be continued until day 10 for BG levels \>200 pg/ml
Diagnostic Test: De-escalation
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.
Antifungal therapy will be stopped according with BG results
Antifungal consumption
Days of antifungal consumption will be compared between the two groups
Time frame: 28 days
Mortality
28-day mortality will be compared between the two groups
Time frame: 28 days
Length of stay
Length of stay in ICU will be compared between the two groups
Time frame: 28 days
Accuracy of BG
sensitivity, specificity, positive predictive value, negative predictive value of BG in the diagnosis of invasive candidiasis
Time frame: 28 days
Plan to share: Undecided
Ran from Mar 2017 to primary completion in Jun 2019, 27 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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