Last reviewed · How we verify
NCT01122368: INTENSE
A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
Phase 2 trial testing micafungin in Mycoses in 252 participants. Completed in 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
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01122368
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of micafungin
Trials testing the same drug.
- NCT01200355 — Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergo · Phase 4 · completed
- NCT01058174 — Liver Transplant European Study Into the Prevention of Fungal Infection · Phase 3 · completed
Other Astellas Pharma Inc trials
Trials by the same sponsor.
- NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
- NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01122368 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
- Last refreshed: 19 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01122368.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing