A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
NCT ID: NCT01122368
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
252 participants
INTERVENTIONAL
2010-07-13
2011-12-15
Brief Summary
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Detailed Description
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* Baseline (after surgery, prior to randomization)
* End of Treatment (EOT) visit (EOT is defined as: requires alternative antifungal, sufficient improvement of surgical condition, confirmed fungal infection or death)
* End of Study visit (28 days after the EOT visit)
* Long-term Follow up visit (90 days after the EOT visit)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1 Micafungin
IV
micafungin
IV
2 Placebo
IV
placebo
IV
Interventions
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micafungin
IV
placebo
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If Community Acquired Intra-Abdominal Infection, at least 72 hours (but not more than 120 hours) of Intensive Care Unit stay, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
* If Nosocomial Intra-Abdominal Infection, duration of Intensive Care Unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
* Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study
Exclusion Criteria
* Neutropenia (ANC \<1,000/mm3) at the time of randomization
* Infected intra-peritoneal dialysis
* Patients undergoing solid organ transplantation
* Documented invasive candidiasis at the time of randomization
* Expected survival \< 48 hours
* Any systemically active anti-fungal within 14 days prior to administration of the study drug
* Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients
* Currently receiving and/or has taken an investigational drug within 28 days prior to randomization
* Pregnant woman or breast-feeding mother
* 'Do Not Resuscitate' order
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe Ltd.
Locations
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Innsbruck, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Liège, , Belgium
Viborg, , Denmark
Jyväskylä, , Finland
Kuopio, , Finland
Tampere, , Finland
Amiens, , France
La Roche-sur-Yon, , France
Limoges, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Poitiers, , France
Cologne, , Germany
Freiburg im Breisgau, , Germany
Hanover, , Germany
Leipzig, , Germany
Lübeck, , Germany
Athens, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Debrecen, , Hungary
Győr, , Hungary
Szeged, , Hungary
Ramat Gan, , Israel
Tel Aviv, , Israel
Bologna, , Italy
Milan, , Italy
Monza, , Italy
Pisa, , Italy
Roma, , Italy
Roma, , Italy
Verona, , Italy
Bucharest, , Romania
Oradea, , Romania
Timișoara, , Romania
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Valladolid, , Spain
Lausanne, , Switzerland
Ankara, , Turkey (Türkiye)
Ege, , Turkey (Türkiye)
Eskişehir, , Turkey (Türkiye)
Trabzon, , Turkey (Türkiye)
Blackpool, , United Kingdom
Leeds, , United Kingdom
Leeds, , United Kingdom
Countries
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References
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White PL, Posso R, Parr C, Price JS, Finkelman M, Barnes RA. The Presence of (1-->3)-beta-D-Glucan as Prognostic Marker in Patients After Major Abdominal Surgery. Clin Infect Dis. 2021 Oct 5;73(7):e1415-e1422. doi: 10.1093/cid/ciaa1370.
Knitsch W, Vincent JL, Utzolino S, Francois B, Dinya T, Dimopoulos G, Ozgunes I, Valia JC, Eggimann P, Leon C, Montravers P, Phillips S, Tweddle L, Karas A, Brown M, Cornely OA. A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections. Clin Infect Dis. 2015 Dec 1;61(11):1671-8. doi: 10.1093/cid/civ707. Epub 2015 Aug 13.
Related Links
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Link to results on the Astellas Clinical Study Results website.
Other Identifiers
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2008-006409-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9463-EC-0002
Identifier Type: -
Identifier Source: org_study_id
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