WHO ICTRP trial
A ß-d-glucan guided antifungal stewardship strategy for the management of…
EUCTR2016-002335-14-IT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2016-002335-14-IT |
|---|---|
| Public title | A ß-d-glucan guided antifungal stewardship strategy for the management of patients with severe abdominal sepsis. A multicenter interventional explorative study with a pharmadynamic/pharmachokinetic substudy entitled: “A Pilot substudy of Liposomal Amphotericin B Pharmacodynamics in Patients with Abdominal Sepsis” conducted only in the coordinating center |
| Scientific title | A ß-d-glucan guided antifungal stewardship strategy for the management of patients with severe abdominal sepsis. A multicenter interventional explorative study with a pharmadynamic/pharmachokinetic substudy entitled: “A Pilot substudy of Liposomal Amphotericin B Pharmacodynamics in Patients with… |
| Primary sponsor | AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Italy |
| Conditions | Patients with severe sepsis or septic shock MedDRA version: 23.1 Level: PT Classification code 10066593 Term: Post procedural sepsis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification… |
| Interventions | Trade Name: AMBISOME - 50 MG POLVERE PER SOLUZIONE PER INFUSIONE 10 FLACONCINI Product Name: AmBisome Product Code: [AmBisome] Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: AMFOTERICINA B Current Sponsor code… |
| Registration date | Apr 11, 2020 |
| Target size | 40 |
| Secondary IDs | LAMBDA;LAMBDA |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: