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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006409-18 | EudraCT Number |
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Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.
Subjects will be assessed at the following visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Micafungin | Experimental | IV |
|
| 2 Placebo | Placebo Comparator | IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Invasive Fungal Infection | During treatment | |
| Time from baseline to the first confirmation of Invasive Fungal Infection | Baseline to End of Treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence during the treatment period and the time to confirmation of the composite endpoint (defined as confirmation of Invasive Fungal Infection and/or administration of alternative anti-fungal therapy) | At the EOT visit | |
| The emergence or persistence of fungal colonization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32914187 | Derived | 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. | |
| 26270686 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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| placebo | Drug | IV |
|
| At the EOT visit |
| The level of organ dysfunction | At the EOT visit |
| To assess the requirement for additional abdominal surgery/intervention. | At the End of Study visit |
| Organ failure-free days | From Day 1 until 28 days after end of study drug treatment |
| Fungal-free survival | From Day 1 until 28 days after end of study drug treatment |
| Intensive Care Unit (ICU)-free days | From Day 1 until 28 days after end of study drug treatment |
| All-cause mortality | At the End of Study and Long-Term Follow Up visit |
| Health-related quality of life | At the End of Study visit |
| Assessment of the safety of micafungin when used as a pre-emptive treatment | At the End of Study visit |
| Salzburg |
| 5020 |
| Austria |
| Vienna | 1030 | Austria |
| Vienna | 1090 | Austria |
| Brussels | 1070 | Belgium |
| Brussels | 1200 | Belgium |
| Edegem | 2650 | Belgium |
| Ghent | 9000 | Belgium |
| Liège | 4000 | Belgium |
| Viborg | 8800 | Denmark |
| Jyväskylä | 40620 | Finland |
| Kuopio | 70210 | Finland |
| Tampere | 33521 | Finland |
| Amiens | 84054 | France |
| La Roche-sur-Yon | 85925 | France |
| Limoges | 87042 | France |
| Paris | 75674 | France |
| Paris | 75679 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86021 | France |
| Cologne | 50937 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hanover | 30625 | Germany |
| Leipzig | 04103 | Germany |
| Lübeck | 23562 | Germany |
| Athens | 12461 | Greece |
| Thessaloniki | 57001 | Greece |
| Thessaloniki | 57010 | Greece |
| Debrecen | 4032 | Hungary |
| Győr | 9023 | Hungary |
| Szeged | 6720 | Hungary |
| Ramat Gan | 52621 | Israel |
| Tel Aviv | 64239 | Israel |
| Bologna | 40138 | Italy |
| Milan | 20142 | Italy |
| Monza | 20052 | Italy |
| Pisa | 56126 | Italy |
| Roma | 00161 | Italy |
| Roma | 00168 | Italy |
| Verona | 37126 | Italy |
| Bucharest | 50098 | Romania |
| Oradea | 410168 | Romania |
| Timișoara | 300748 | Romania |
| Barcelona | 08003 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28046 | Spain |
| Valencia | 46014 | Spain |
| Valladolid | 47012 | Spain |
| Lausanne | 1011 | Switzerland |
| Ankara | 06100 | Turkey (Türkiye) |
| Ege | 35100 | Turkey (Türkiye) |
| Eskişehir | 26480 | Turkey (Türkiye) |
| Trabzon | 61080 | Turkey (Türkiye) |
| Blackpool | FY3 8NR | United Kingdom |
| Leeds | LS1 3EX | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D000072742 | Invasive Fungal Infections |
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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