INTENSE: A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01122368

Collaborator

(none)

252

Enrollment

Locations

Arms

17.1

Actual Duration (Months)

4.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycoses	Drug: micafungin Drug: placebo	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jul 13, 2010

Actual Primary Completion Date :

Dec 15, 2011

Actual Study Completion Date :

Dec 15, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Micafungin IV	Drug: micafungin IV Other Names: FK463 mycamine
Placebo Comparator: 2 Placebo IV	Drug: placebo IV

Arm

Intervention/Treatment

Experimental: 1 Micafungin

Drug: micafungin

Other Names:

FK463

mycamine

Placebo Comparator: 2 Placebo

Drug: placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	City	Country	Postal Code
1	Innsbruck	Austria	6020
2	Salzburg	Austria	5020
3	Wien	Austria	1030
4	Wien	Austria	1090
5	Brussels	Belgium	1070
6	Brussels	Belgium	1200
7	Edegem	Belgium	2650
8	Gent	Belgium	9000
9	Liege	Belgium	4000
10	Viborg	Denmark	8800
11	Jyvaskyla	Finland	40620
12	Kuopio	Finland	70210
13	Tampere	Finland	33521
14	Amiens	France	84054
15	La Roche sur Yon Cedex 9	France	85925
16	Limoges	France	87042
17	Paris Cedex 14	France	75674
18	Paris	France	75679
19	Pierre Benite	France	69495
20	Poitiers	France	86021
21	Freiburg	Germany	79106
22	Hannover	Germany	30625
23	Koln	Germany	50937
24	Leipzig	Germany	04103
25	Lubeck	Germany	23562
26	Athens	Greece	12461
27	Thessaloniki	Greece	57001
28	Thessaloniki	Greece	57010
29	Debrecen	Hungary	4032
30	Gyor	Hungary	9023
31	Szeged	Hungary	6720
32	Ramat Gan	Israel	52621
33	Tel Aviv	Israel	64239
34	Bologna	Italy	40138
35	Milano	Italy	20142
36	Monza	Italy	20052
37	Pisa	Italy	56126
38	Roma	Italy	00161
39	Roma	Italy	00168
40	Verona	Italy	37126
41	Bucharest	Romania	50098
42	Oradea	Romania	410168
43	Timisoara	Romania	300748
44	Barcelona	Spain	08003
45	Madrid	Spain	28006
46	Madrid	Spain	28046
47	Valencia	Spain	46014
48	Valladolid	Spain	47012
49	Lausanne	Switzerland	1011
50	Ankara	Turkey	06100
51	Ege	Turkey	35100
52	Eskisehir	Turkey	26480
53	Trabzon	Turkey	61080
54	Blackpool	United Kingdom	FY3 8NR
55	Leeds	United Kingdom	LS1 3EX
56	Leeds	United Kingdom	LS9 7TF