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ACTIVE NOT RECRUITING
NCT04368559
PHASE3

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

Sponsor: Mundipharma Research Limited

View on ClinicalTrials.gov

Summary

The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

602

Start Date

2020-05-11

Completion Date

2026-02

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

Rezafungin for Injection

Intravenous antifungal therapy

DRUG

Posaconazole

Oral antifungal therapy

DRUG

Fluconazole

Oral antifungal therapy

DRUG

Trimethoprim-sulfamethoxazole (TMP/SMX)

Oral antibacterial therapy

DRUG

Intravenous Placebo

Normal saline

DRUG

Oral Placebo

Microcrystalline cellulose

Locations (53)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UCLA Center for Health Sciences

Los Angeles, California, United States

Stanford University School of Medicine

Stanford, California, United States

Augusta University Medical Center

Augusta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

John Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Minnesota Physicians

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Mary Hitchcock Memorial Hospital Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Stony Brook University Hospital

Stony Brook, New York, United States

The University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

VCU Medical Center Main Hospital

Richmond, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

AZ Sint-Jan

Bruges, West Vlaanderen, Belgium

University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven

Leuven, Belgium

Hamilton Health Sciences' Juravinski Hospital

Hamilton, Canada

McGill University Health Center

Montreal, Canada

Jean Minjoz Hospital

Besançon, France

Henri Mondor Hospital

Créteil, France

Grenoble Alpes University Hospital Center

Grenoble, France

University Hospital of Limoges

Limoges, France

University Hospital of Nantes

Nantes, France

Hospital Saint Antoine Ap-Hp

Paris, France

University Hospital of Bordeaux

Pessac, France

Lyon-Sud Hospital Center

Pierre-Bénite, France

University Hospital of Cologne

Cologne, Germany

University Hospital Carl Gustav Carus Dresden

Dresden, Germany

Johannes Gutenberg University Medical Center

Mainz, Germany

University Hospital Münster

Münster, Germany

University Hospital Wurzburg UKW

Würzburg, Germany

San Martino Polyclinic Hospital

Genova, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Agostino Gemelli University Policlinic

Rome, Italy

Humanitas Cancer Center

Rozzano, Italy

University Hospital Vall d'Hebron

Barcelona, Spain

Hospital Clinic of Barcelona

Barcelona, Spain

University Hospital Ramon y Cajal

Madrid, Spain

Puerta de Hierro Majadahonda University Hospital

Majadahonda, Spain

University Hospital of Salamanca

Salamanca, Spain

University Hospital Marques de Valdecilla

Santander, Spain

University Hospital of Valencia

Valencia, Spain

La Fe University and Polytechnic Hospital

Valencia, Spain

University Hospitals Geneva

Geneva, Switzerland

Addenbrookes Hospital

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Kings College Hospital NHS Foundation Trust

London, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

The Royal Marsden Nhs Foundation Trust

London, United Kingdom