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AzTrials

CandidemiaPhase 3ReSPECTNCT04368559

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

A Phase 3 study testing Rezafungin for Injection, Posaconazole and Fluconazole in people with Candidemia and Mycoses, run by Mundipharma Research Limited at 53 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidemia, Mycoses, Fungal Infection
What is being tested?
Rezafungin for Injection, Posaconazole and Fluconazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
602 participants
Where
53 sitesin 9 countries
Study dates
11 May 2020to 29 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent.
  • Males or females ≥18 years of age.
  • Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
  • Diagnosed with 1 of the following underlying diseases:
  • Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
  • Acute lymphoblastic leukemia, in first or second complete remission.
Show all 35Show fewer
  • Acute undifferentiated leukemia in first or second remission.
  • Acute biphenotypic leukemia in first or second complete remission.
  • Chronic myelogenous leukemia in either chronic or accelerated phase.
  • One of the following myelodysplastic syndrome(s) defined by the following:
  • Refractory anemia.
  • Refractory anemia with ringed sideroblasts.
  • Refractory cytopenia with multilineage dysplasia.
  • Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.
  • Refractory anemia with excess blasts - 1 (5-10% blasts).
  • Refractory anemia with excess blasts - 2 (10-20% blasts).
  • Myelodysplastic syndrome, unclassified.
  • Myelodysplastic syndrome associated with isolated del (5q).
  • Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related or unrelated donor transplant.
  • Aplastic anemia.
  • Primary or secondary myelofibrosis.
  • Chronic myelomonocytic leukemia.
  • Chronic lymphocytic leukemia.
  • Drepanocytosis (sickle cell anemia).
  • Red blood cell aplasia.
  • Myeloproliferative disorder, unclassified.
  • Multiple myeloma (plasma cell myeloma).
  • Receiving myeloablative or reduced-intensity conditioning regimens.
  • Adequate renal and hepatic function prior to initiation of conditioning regimen, therefore between 40 days prior and 10 days prior to BMT, documented as follows:
  • Hepatic: alanine aminotransferase less than or equal to (≤) 2.5 × upper limit of normal (ULN) and total serum bilirubin ≤1.5 × ULN (excluding Gilbert's Syndrome).
  • Renal: serum creatinine ≤2 milligrams (mg)/deciliter (dL) and with creatinine clearance (CrCl) greater than or equal to (≥) 30 milliliters (mL)/minute (min) without a history of renal transplant, or undergoing weekly dialysis within 4 weeks of the BMT.
  • Baseline blood samples drawn for Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 15 days before randomization, with results available prior to randomization.
  • Baseline Toxoplasma serologies available within 6 weeks prior to randomization. Subjects with a positive toxoplasma IgG serology at any time prior to randomization do not need to repeat the toxoplasma serologies (IgG and IgM) and will be considered to have a prior history of toxoplasmosis.
  • Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency determination by the investigator prior to randomization with no known evidence of G6PD deficiency performed any time prior to randomization. If the Investigator assesses the subject as G6PD sufficient, the G6PD test result does not need to be entered into the EDC system.
  • Female subjects of child-bearing potential <2 years post-menopausal (unless surgically sterile) must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subject's usual lifestyle) while participating in this study, and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug.

Who cannot join

  • Diagnosis of AML not in morphological remission.
  • Diagnosis of chemotherapy-resistant lymphoma: a first relapse can occur provided that a second complete remission has occurred.
  • Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of randomisation.
  • Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤50%, or shortening fraction ≤26%.
  • Personal or family history of Long QT interval on electrocardiogram (ECG) (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericia's formula (QTcF) (>470 milliseconds [msec] in males and >480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, quinidine, or halofantrine.
  • Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin) or forced expiratory volume in 1 second (FEV1) ≤65% of predicted value, or O2 saturation ≤82% on room air.
Show all 25Show fewer
  • Suspected or documented PCP within 2 years of screening.
  • Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (Fungitell ≥80 picograms [pg]/mL or Fujifilm Wako >11 pg/mL) within 15 days prior to the transplant.
  • Receipt of previous allogeneic BMT.
  • Planned receipt of cord blood for transplantation.
  • Planned peripheral blood or marrow autograft.
  • Not applicable to protocol Amendment 6.
  • Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy, per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  • History of severe (Grade ≥3) ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease).
  • . .
  • Planned or ongoing intake at screening of a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of CTCAE version 5.0 Grade 1 or higher.
  • Any contraindication or a medication or supplement known to severely interact with the standard antimicrobial regimen (SAR) as detailed in the US Prescribing Information (USPI) or Summary of Product Characteristics (SmPC) of fluconazole, posaconazole, or TMP/SMX.
  • Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients.
  • Known hypersensitivity or inability to receive TMP/SMX or any of its excipients, including but not limited to anaphylaxis, exfoliative skin disorders, or acute porphyria.
  • Recent use of an investigational medicinal product within 28 days or 5 half-lives of the investigational medicinal product, whichever is greater, to prevent overlapping toxicities when this study's investigational product is dosed, or presence of an investigational device at the time of screening. In some cases, use of investigational products may be acceptable in consultation with the Sponsor's Medical Monitor.
  • Known infection with HIV. Subjects with unknown HIV status should be tested for HIV antibodies per standard of care.
  • Pregnant or lactating females.
  • The Principal Investigator (PI) determines that the subject should not participate in the study.
  • Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center).
  • Known liver cirrhosis, diagnosed according to country or Medical Society specific guidelines and documented in the medical records prior to initiating conditioning regimen.

Trial locations and contacts

53 sites in 9 countries.

53 sites in 9 countries

United States18 sites

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • John Hopkins

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Mary Hitchcock Memorial Hospital Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

  • UCLA Center for Health Sciences

    Los Angeles, California, 90095

  • University of Minnesota Physicians

    Minneapolis, Minnesota, 55455

  • The University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • VCU Medical Center Main Hospital

    Richmond, Virginia, 23219

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98108

  • Stanford University School of Medicine

    Stanford, California, 94304

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

Other trials in United States

France8 sites

  • Jean Minjoz Hospital

    Besançon, 25030

  • Henri Mondor Hospital

    Créteil, 94000

  • Grenoble Alpes University Hospital Center

    Grenoble, 38043

  • University Hospital of Limoges

    Limoges, 87042

  • University Hospital of Nantes

    Nantes, 44093

  • Hospital Saint Antoine Ap-Hp

    Paris, 75012

  • University Hospital of Bordeaux

    Pessac, 33604

  • Lyon-Sud Hospital Center

    Pierre-Bénite, 69495

Other trials in France

Spain8 sites

  • University Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic of Barcelona

    Barcelona, 08036

  • University Hospital Ramon y Cajal

    Madrid, 28034

  • Puerta de Hierro Majadahonda University Hospital

    Majadahonda, 28220

  • University Hospital of Salamanca

    Salamanca, 37007

  • University Hospital Marques de Valdecilla

    Santander, 39008

  • University Hospital of Valencia

    Valencia, 46010

  • La Fe University and Polytechnic Hospital

    Valencia, 46026

Other trials in Spain

Germany5 sites

  • University Hospital of Cologne

    Cologne, 50937

  • University Hospital Carl Gustav Carus Dresden

    Dresden, 01307

  • Johannes Gutenberg University Medical Center

    Mainz, 55131

  • University Hospital Münster

    Münster, 48149

  • University Hospital Wurzburg UKW

    Würzburg, 97080

Other trials in Germany

United Kingdom5 sites

  • Addenbrookes Hospital

    Cambridge, cb2 0QQ

  • University Hospital of Wales

    Cardiff, CF144XW

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • The Royal Marsden Nhs Foundation Trust

    London, SW3 6JJ

Other trials in United Kingdom

Italy4 sites

  • San Martino Polyclinic Hospital

    Genova, 16132

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Agostino Gemelli University Policlinic

    Rome, 00168

  • Humanitas Cancer Center

    Rozzano, 20089

Other trials in Italy

Belgium2 sites

  • AZ Sint-Jan

    Bruges, West Vlaanderen, 8000

  • University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven

    Leuven, 3000

Other trials in Belgium

Canada2 sites

  • Hamilton Health Sciences' Juravinski Hospital

    Hamilton, L8V1C3

  • McGill University Health Center

    Montreal, H4A3J1

Other trials in Canada

Switzerland1 site

  • University Hospitals Geneva

    Geneva, 1211

Other trials in Switzerland

About this study

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)

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.

Read the detailed description

A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for injection versus the standard antimicrobial regimen for the prevention of invasive fungal diseases in subjects undergoing allogeneic blood and marrow transplantation.

Being tested
Rezafungin for Injection, Posaconazole, Fluconazole, Trimethoprim-sulfamethoxazole (TMP/SMX), Intravenous Placebo
Keywords
Mycoses, Prophylaxis of Invasive Fungal Infections, Aspergillus, Candidiasis, Candidemia, Candidiasis, Invasive, Fungemia, Sepsis, Blood and Marrow Transplant (BMT), Infection, Invasive Fungal Infections, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes, Fluconazole, Posaconazole, Caspofungin, Trimethoprim-sulfamethoxazole (TMP/SMX), Echinocandins, Antifungal Agents
Medical subject headings
Candidemia, Mycoses, Fungemia, Candidiasis, Invasive, Pneumonia, Pneumocystis, Invasive Fungal Infections, Candidiasis, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rezafungin for InjectionDrug

    Also called Intravenous antifungal therapy

    Intravenous antifungal therapy

  • PosaconazoleDrug

    Also called Noxafil

    Oral antifungal therapy

  • FluconazoleDrug

    Also called Generic Fluconazole

    Oral antifungal therapy

  • Trimethoprim-sulfamethoxazole (TMP/SMX)Drug

    Also called Bactrim, Septra

    Oral antibacterial therapy

  • Intravenous PlaceboDrug

    Also called Placebo Infusion

    Normal saline

  • Oral PlaceboDrug

    Also called encapsulated cellulose

    Microcrystalline cellulose

Study groups in NCT04368559
Study groupRoleWhat they receive
Group 1: Rezafungin for InjectionExperimentalSubjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 13 weeks. Subjects will receive oral placebo for standard antimicrobial regimen (SAR) azole prophylaxis and oral placebo for SAR anti-Pneumocystis pneumonia (PCP) prophylaxis in accordance with the respective SAR dosing regimens for each. For subjects who are switched to a SAR IV regimen, oral placebo for SAR azole prophylaxis will be changed to IV placebo. There is no IV option for SAR anti-PCP prophylaxis.
Receives: Drug: Rezafungin for Injection; Drug: Intravenous Placebo; Drug: Oral Placebo
Group 2: Oral AntifungalActive comparatorSubjects randomized to the SAR will receive either fluconazole or posaconazole as the first-line SAR as per site's standard practice. Fluconazole will be administered orally at once daily doses of 400 mg for 13 weeks. Posaconazole will be administered orally as 300 mg twice daily on the first day and 300 mg once daily thereafter for 13 weeks. Azole-based antifungal therapy (fluconazole or posaconazole) can be switched from oral therapy to IV therapy if there is oral intolerance, at the discretion of the Investigator. Subjects who started on fluconazole SAR may be switched to posaconazole at the discretion of the Investigator if they develop acute clinically significant GVHD; In addition, subjects in the SAR group will receive anti PCP prophylaxis with oral TMP/SMX (80 mg TMP/ 400 mg SMX) once daily. There is no IV option for SAR anti-PCP prophylaxis.
Receives: Drug: Posaconazole; Drug: Fluconazole; Drug: Trimethoprim-sulfamethoxazole (TMP/SMX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Noninferior Fungal-Free Survival (US FDA)

    The number of subjects in each treatment group who are fungal-free and survive.

    Measured: Day 90 (±7 days)

  2. Noninferior Fungal-Free Survival (US FDA)

    The percentage of subjects in each treatment group who are fungal-free and survive.

    Measured: Day 90 (±7 days)

  3. Superior Fungal-Free Survival (EMA)

    The number of subjects in each treatment group who are fungal-free and survive.

    Measured: Day 90 (±7 days)

  4. Superior Fungal-Free Survival (EMA)

    The percentage of subjects in each treatment group who are fungal-free and survive.

    Measured: Day 90 (±7 days)

Secondary outcomes (9)

  1. Compare Discontinuation for Toxicity or Intolerance

    The number of subjects that discontinued Rezafungin for Injection compared to the standard antimicrobial regimen (SAR) secondary to toxicity or intolerance.

    Measured: Day 90 (±7 days)

  2. Compare Discontinuation for Toxicity or Intolerance

    The percentage of subjects that discontinued Rezafungin for Injection compared to the standard antimicrobial regimen (SAR) secondary to toxicity or intolerance.

    Measured: Day 90 (±7 days)

  3. Compare Proven and Probable IFD

    The number of subjects in each treatment group who have proven and probable IFD including the number of invasive infections from Candida spp., Aspergillus spp., and Pneumocystis jirovecii.

    Measured: Day 90 (±7 days)

  4. Compare Proven and Probable IFD

    The percentage of subjects in each treatment group who have proven and probable IFD including the number of invasive infections from Candida spp., Aspergillus spp., and Pneumocystis jirovecii.

    Measured: Day 90 (±7 days)

  5. Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD

    The number of subjects in each treatment group who are fungal-free survival with or without a diagnosis of clinically significant GVHD.

    Measured: Day 90 (±7 days)

  6. Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD

    The percentage of subjects in each treatment group who are fungal-free survival with or without a diagnosis of clinically significant GVHD.

    Measured: Day 90 (±7 days)

  7. Compare Time to IFD, or Death

    Evaluate time to IFD (proven or probable IFD) or death in subjects randomized to Rezafungin for Injection compared to the standard antimicrobial regimen (SAR).

    Measured: Day 90 (±7 days)

  8. Compare Mortality

    Evaluate overall mortality and attributable mortality, with and without adjustment for patient comorbidity indices, in subjects randomized to Rezafungin for Injection compared to the SAR.

    Measured: Day 1 through follow-up visit (Day 120)

  9. Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]

    The number of subjects with incidence of treatment emergent adverse events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.

    Measured: Day 1 through follow-up visit (Day 120)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start11 May 2020
  3. Primary completion29 Jan 2026
  4. Study completion29 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368559
Sponsor's protocol ID
CD101.IV.3.08
Other IDs
2017-004981-85, 2017
Acronym
ReSPECT
Status last verified
Apr 2026
First submitted
22 Apr 2020
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cross SJ, Wolf J, Patel PA. Prevention, Diagnosis and Management of Pneumocystis jirovecii Infection in Children With Cancer or Receiving Hematopoietic Cell Therapy. Pediatr Infect Dis J. 2023 Dec 1;42(12):e479-e482. doi: 10.1097/INF.0000000000004102. Epub 2023 Sep 21. No abstract available.

    PubMed 37773627

  • Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217.

    PubMed 33438477

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rezafungin for Injection, Posaconazole and Fluconazole in people with Candidemia and Mycoses, run by Mundipharma Research Limited at 53 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, France, Spain, Germany, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Noninferior Fungal-Free Survival (US FDA) (time frame: Day 90 (±7 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04368559, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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