NCT01122368: INTENSE

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

Completed Phase 2 Last updated 19 November 2024

What this trial tests

Phase 2 trial testing micafungin in Mycoses in 252 participants. Completed in 15 December 2011.

Timeline

13 July 2010

Primary endpoint
15 December 2011

15 December 2011

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	252
Start date	13 July 2010
Primary completion	15 December 2011
Estimated completion	15 December 2011
Sites	56 locations across France, Denmark, Finland, Italy, Greece, Belgium, Austria, United Kingdom

Drugs / interventions tested

• micafungin (MICAFUNGIN) — full drug profile →
• placebo

Conditions studied

• Mycoses — all drugs for Mycoses →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, any sex, with Mycoses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Candida colonization index and subsequent infection in critically ill surgical patients: 20 years later.
   Eggimann P, Pittet D. · · 2014 · cited 99× · PMID 24934813 · DOI 10.1007/s00134-014-3355-z
2. A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections.
   Knitsch W, Vincent JL, Utzolino S, François B, et al · · 2015 · cited 60× · PMID 26270686 · DOI 10.1093/cid/civ707
3. Antifungal agents for preventing fungal infections in non-neutropenic critically ill patients.
   Cortegiani A, Russotto V, Maggiore A, Attanasio M, et al · · 2016 · cited 48× · PMID 26772902 · DOI 10.1002/14651858.cd004920.pub3
4. The Presence of (1→3)-β-D-Glucan as Prognostic Marker in Patients After Major Abdominal Surgery.
   White PL, Posso R, Parr C, Price JS, et al · · 2021 · cited 10× · PMID 32914187 · DOI 10.1093/cid/ciaa1370
5. Management of invasive candidiasis in nonneutropenic ICU patients.
   Weiss E, Timsit JF. · · 2014 · cited 4× · PMID 25745560 · DOI 10.1177/2049936114562586
6. Empiric/pre-emptive anti-Candida therapy in non-neutropenic ICU patients.
   Timsit JF, Chemam S, Bailly S. · · 2015 · cited 2× · PMID 25750739 · DOI 10.12703/p7-21