MycosesPhase 2INTENSENCT01122368
A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
A Phase 2 study testing micafungin in people with Mycoses, run by Astellas Pharma Inc at 56 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycoses
- What is being tested?
- micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 56 sitesin 15 countries
- Study dates
- 13 Jul 2010to 15 Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
56 sites in 15 countries.
56 sites in 15 countries
France7 sites
Study site
Amiens, 84054
Study site
La Roche-sur-Yon, 85925
Study site
Limoges, 87042
Study site
Paris, 75674
Study site
Paris, 75679
Study site
Pierre-Bénite, 69495
Study site
Poitiers, 86021
Italy7 sites
Study site
Bologna, 40138
Study site
Milan, 20142
Study site
Monza, 20052
Study site
Pisa, 56126
Study site
Roma, 00161
Study site
Roma, 00168
Study site
Verona, 37126
Belgium5 sites
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Liège, 4000
Germany5 sites
Study site
Cologne, 50937
Study site
Freiburg im Breisgau, 79106
Study site
Hanover, 30625
Study site
Leipzig, 04103
Study site
Lübeck, 23562
Spain5 sites
Study site
Barcelona, 08003
Study site
Madrid, 28006
Study site
Madrid, 28046
Study site
Valencia, 46014
Study site
Valladolid, 47012
Austria4 sites
Study site
Innsbruck, 6020
Study site
Salzburg, 5020
Study site
Vienna, 1030
Study site
Vienna, 1090
Turkey (Türkiye)4 sites
Study site
Ankara, 06100
Study site
Ege, 35100
Study site
Eskişehir, 26480
Study site
Trabzon, 61080
Finland3 sites
Study site
Jyväskylä, 40620
Study site
Kuopio, 70210
Study site
Tampere, 33521
Greece3 sites
Study site
Athens, 12461
Study site
Thessaloniki, 57001
Study site
Thessaloniki, 57010
Hungary3 sites
Study site
Debrecen, 4032
Study site
Győr, 9023
Study site
Szeged, 6720
Romania3 sites
Study site
Bucharest, 50098
Study site
Oradea, 410168
Study site
Timișoara, 300748
United Kingdom3 sites
Study site
Blackpool, FY3 8NR
Study site
Leeds, LS1 3EX
Study site
Leeds, LS9 7TF
About this study
Official title: 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
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.
Read the detailed description
Subjects will be assessed at the following visits:
- 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
- Mycoses
- Being tested
- micafungin, placebo
- Keywords
- mycoses, Micafungin, intra-abdominal surgery, invasive fungal infection, intra-abdominal infection
- Medical subject headings
- Mycoses, Invasive Fungal Infections, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micafunginDrug
Also called FK463, mycamine
IV
placeboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 Micafungin | Experimental | IV Receives: Drug: micafungin |
| 2 Placebo | Placebo comparator | IV Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Invasive Fungal Infection
Measured: During treatment
Time from baseline to the first confirmation of Invasive Fungal Infection
Measured: 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)
Measured: At the EOT visit
The emergence or persistence of fungal colonization
Measured: At the EOT visit
The level of organ dysfunction
Measured: At the EOT visit
To assess the requirement for additional abdominal surgery/intervention.
Measured: At the End of Study visit
Organ failure-free days
Measured: From Day 1 until 28 days after end of study drug treatment
Fungal-free survival
Measured: From Day 1 until 28 days after end of study drug treatment
Intensive Care Unit (ICU)-free days
Measured: From Day 1 until 28 days after end of study drug treatment
All-cause mortality
Measured: At the End of Study and Long-Term Follow Up visit
Health-related quality of life
Measured: At the End of Study visit
Assessment of the safety of micafungin when used as a pre-emptive treatment
Measured: At the End of Study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study start13 Jul 2010
- Primary completion15 Dec 2011
- Study completion15 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MycosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122368
- Sponsor's protocol ID
- 9463-EC-0002
- Other IDs
- 2008-006409-18, 2008
- Acronym
- INTENSE
- Status last verified
- Nov 2024
- First submitted
- 10 May 2010
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 32914187Knitsch 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.
PubMed 26270686
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01122368
- Acronym / sponsor ID
- INTENSE / 9463-EC-0002
- Conditions
- Mycoses
- Keywords
- mycoses, Micafungin, intra-abdominal surgery, invasive fungal infection, intra-abdominal infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2010 (actual)
- Primary completion
- 15 Dec 2011 (actual)
- Study completion
- 15 Dec 2011 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be assessed at the following visits:
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Micafungin | Experimental | Drug: micafunginIV |
| 2 Placebo | Placebo comparator | Drug: placeboIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micafunginAlso: FK463, mycamineIV | Drug | 1 Micafungin |
| placeboIV | Drug | 2 Placebo |
Primary outcome
The incidence of Invasive Fungal Infection
Time frame: During treatment
Time from baseline to the first confirmation of Invasive Fungal Infection
Time frame: Baseline to End of Treatment visit
10 secondary outcomes
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)
Time frame: At the EOT visit
The emergence or persistence of fungal colonization
Time frame: At the EOT visit
The level of organ dysfunction
Time frame: At the EOT visit
To assess the requirement for additional abdominal surgery/intervention.
Time frame: At the End of Study visit
Organ failure-free days
Time frame: From Day 1 until 28 days after end of study drug treatment
Fungal-free survival
Time frame: From Day 1 until 28 days after end of study drug treatment
Intensive Care Unit (ICU)-free days
Time frame: From Day 1 until 28 days after end of study drug treatment
All-cause mortality
Time frame: At the End of Study and Long-Term Follow Up visit
Health-related quality of life
Time frame: At the End of Study visit
Assessment of the safety of micafungin when used as a pre-emptive treatment
Time frame: At the End of Study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 32914187White 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.
- Derived from this study: PubMed 26270686Knitsch 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.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study chair
Astellas Pharma Europe Ltd.
56 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing micafungin in people with Mycoses, run by Astellas Pharma Inc at 56 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in France, Italy, Belgium, Germany, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Invasive Fungal Infection (time frame: During treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122368, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.