A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
INTENSE
An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study
2 other identifiers
interventional
252
15 countries
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
Shorter than P25 for phase_2
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedStudy Start
First participant enrolled
July 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2011
CompletedNovember 19, 2024
November 1, 2024
1.4 years
May 10, 2010
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (10)
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
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
- +5 more secondary outcomes
Study Arms (2)
1 Micafungin
EXPERIMENTALIV
2 Placebo
PLACEBO COMPARATORIV
Interventions
Eligibility Criteria
You may qualify if:
- Intra-abdominal infection requiring surgery and Intensive Care Unit stay
- 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
You may not qualify if:
- Acute pancreatitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Salzburg, 5020, Austria
Unknown Facility
Vienna, 1030, Austria
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Viborg, 8800, Denmark
Unknown Facility
Jyväskylä, 40620, Finland
Unknown Facility
Kuopio, 70210, Finland
Unknown Facility
Tampere, 33521, Finland
Unknown Facility
Amiens, 84054, France
Unknown Facility
La Roche-sur-Yon, 85925, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Cologne, 50937, Germany
Unknown Facility
Freiburg im Breisgau, 79106, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Leipzig, 04103, Germany
Unknown Facility
Lübeck, 23562, Germany
Unknown Facility
Athens, 12461, Greece
Unknown Facility
Thessaloniki, 57001, Greece
Unknown Facility
Thessaloniki, 57010, Greece
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Győr, 9023, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Ramat Gan, 52621, Israel
Unknown Facility
Tel Aviv, 64239, Israel
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Milan, 20142, Italy
Unknown Facility
Monza, 20052, Italy
Unknown Facility
Pisa, 56126, Italy
Unknown Facility
Roma, 00161, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Verona, 37126, Italy
Unknown Facility
Bucharest, 50098, Romania
Unknown Facility
Oradea, 410168, Romania
Unknown Facility
Timișoara, 300748, Romania
Unknown Facility
Barcelona, 08003, Spain
Unknown Facility
Madrid, 28006, Spain
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
Valencia, 46014, Spain
Unknown Facility
Valladolid, 47012, Spain
Unknown Facility
Lausanne, 1011, Switzerland
Unknown Facility
Ankara, 06100, Turkey (Türkiye)
Unknown Facility
Ege, 35100, Turkey (Türkiye)
Unknown Facility
Eskişehir, 26480, Turkey (Türkiye)
Unknown Facility
Trabzon, 61080, Turkey (Türkiye)
Unknown Facility
Blackpool, FY3 8NR, United Kingdom
Unknown Facility
Leeds, LS1 3EX, United Kingdom
Unknown Facility
Leeds, LS9 7TF, United Kingdom
Related Publications (2)
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.
PMID: 32914187DERIVEDKnitsch 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.
PMID: 26270686DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 13, 2010
Study Start
July 13, 2010
Primary Completion
December 15, 2011
Study Completion
December 15, 2011
Last Updated
November 19, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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/.