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

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.

Study Overview

• Status: Completed
• Conditions: Mycoses; Candidemia; Fungemia; Fungal Infection; Invasive Candidiasis; Invasive Fungal Disease; Pneumocystis; Mold Infection; Prophylaxis of Invasive Fungal Infections; Aspergillus
• Intervention / Treatment: Drug: Rezafungin for Injection; Drug: Intravenous Placebo; Drug: Oral Placebo; Drug: Posaconazole; Drug: Fluconazole; Drug: Trimethoprim-sulfamethoxazole (TMP/SMX)

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.

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven
  • West Vlaanderen
    • Bruges, West Vlaanderen, Belgium, 8000
      • AZ Sint-Jan
• Canada
  • Hamilton, Canada, L8V1C3
    • Hamilton Health Sciences' Juravinski Hospital
  • Montreal, Canada, H4A3J1
    • McGill University Health Center
• France
  • Besançon, France, 25030
    • Jean Minjoz Hospital
  • Créteil, France, 94000
    • Henri Mondor Hospital
  • Grenoble, France, 38043
    • Grenoble Alpes University Hospital Center
  • Limoges, France, 87042
    • University Hospital of Limoges
  • Nantes, France, 44093
    • University Hospital of Nantes
  • Paris, France, 75012
    • Hospital Saint Antoine Ap-Hp
  • Pessac, France, 33604
    • University Hospital of Bordeaux
  • Pierre-Bénite, France, 69495
    • Lyon-Sud Hospital Center
• Germany
  • Cologne, Germany, 50937
    • University Hospital of Cologne
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav Carus Dresden
  • Mainz, Germany, 55131
    • Johannes Gutenberg University Medical Center
  • Münster, Germany, 48149
    • University Hospital Münster
  • Würzburg, Germany, 97080
    • University Hospital Wurzburg UKW
• Italy
  • Genova, Italy, 16132
    • San Martino Polyclinic Hospital
  • Milan, Italy, 20141
    • IEO Istituto Europeo di Oncologia
  • Rome, Italy, 00168
    • Agostino Gemelli University Policlinic
  • Rozzano, Italy, 20089
    • Humanitas Cancer Center
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona
  • Barcelona, Spain, 08035
    • University Hospital Vall d'Hebron
  • Madrid, Spain, 28034
    • University Hospital Ramon y Cajal
  • Majadahonda, Spain, 28220
    • Puerta de Hierro Majadahonda University Hospital
  • Salamanca, Spain, 37007
    • University Hospital of Salamanca
  • Santander, Spain, 39008
    • University Hospital Marqués de Valdecilla
  • Valencia, Spain, 46026
    • La Fe University and Polytechnic Hospital
  • Valencia, Spain, 46010
    • University Hospital of Valencia
• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospitals Geneva
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Cardiff, United Kingdom, CF144XW
    • University Hospital of wales
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital NHS Foundation Trust
  • London, United Kingdom, SW17 0QT
    • St. George's University Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Center for Health Sciences
    • Stanford, California, United States, 94304
      • Stanford University School of Medicine
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21218
      • John Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Physicians
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Mary Hitchcock Memorial Hospital Dartmouth-Hitchcock
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The University of Oklahoma College of Medicine
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • VCU Medical Center Main Hospital
  • Washington
    • Seattle, Washington, United States, 98108
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Males or females ≥18 years of age.
3. 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.

4. Diagnosed with 1 of the following underlying diseases:

   1. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
   2. Acute lymphoblastic leukemia, in first or second complete remission.
   3. Acute undifferentiated leukemia in first or second remission.
   4. Acute biphenotypic leukemia in first or second complete remission.
   5. Chronic myelogenous leukemia in either chronic or accelerated phase.
   6. One of the following myelodysplastic syndrome(s) defined by the following:

   i. Refractory anemia.

   ii. Refractory anemia with ringed sideroblasts.

   iii. Refractory cytopenia with multilineage dysplasia.

   iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.

   v. Refractory anemia with excess blasts - 1 (5-10% blasts).

   vi. Refractory anemia with excess blasts - 2 (10-20% blasts).

   vii. Myelodysplastic syndrome, unclassified.

   viii. Myelodysplastic syndrome associated with isolated del (5q).

   g. Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related or unrelated donor transplant.

   h. Aplastic anemia.

   i. Primary or secondary myelofibrosis.

   j. Chronic myelomonocytic leukemia.

   k. Chronic lymphocytic leukemia.

   l. Drepanocytosis (sickle cell anemia).

   m. Red blood cell aplasia.

   n. Myeloproliferative disorder, unclassified.

   o. Multiple myeloma (plasma cell myeloma).

5. Receiving myeloablative or reduced-intensity conditioning regimens.

6. 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:

   1. 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).
   2. 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.
7. 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.
8. 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.
9. 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.
10. 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.

Exclusion Criteria:

1. Diagnosis of AML not in morphological remission.
2. Diagnosis of chemotherapy-resistant lymphoma: a first relapse can occur provided that a second complete remission has occurred.
3. Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of randomisation.
4. Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤50%, or shortening fraction ≤26%.
5. 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.
6. 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.
7. Suspected or documented PCP within 2 years of screening.
8. 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.
9. Receipt of previous allogeneic BMT.
10. Planned receipt of cord blood for transplantation.
11. Planned peripheral blood or marrow autograft.
12. Not applicable to protocol Amendment 6.
13. 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.
14. 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).

15. . .

    1. 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.
    2. 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.
16. Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients.
17. 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.
18. 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.
19. Known infection with HIV. Subjects with unknown HIV status should be tested for HIV antibodies per standard of care.
20. Pregnant or lactating females.
21. The Principal Investigator (PI) determines that the subject should not participate in the study.
22. Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center).
23. Known liver cirrhosis, diagnosed according to country or Medical Society specific guidelines and documented in the medical records prior to initiating conditioning regimen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Rezafungin for Injection; Subjects 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.	Drug: Rezafungin for Injection; Intravenous antifungal therapy; Other Names: Intravenous antifungal therapy; Drug: Intravenous Placebo; Normal saline; Other Names: Placebo Infusion; Drug: Oral Placebo; Microcrystalline cellulose; Other Names: encapsulated cellulose
Active Comparator: Group 2: Oral Antifungal; Subjects 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.	Drug: Posaconazole; Oral antifungal therapy; Other Names: Noxafil; Drug: Fluconazole; Oral antifungal therapy; Other Names: Generic Fluconazole; Drug: Trimethoprim-sulfamethoxazole (TMP/SMX); Oral antibacterial therapy; Other Names: Bactrim; Septra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninferior Fungal-Free Survival (US FDA)	The number of subjects in each treatment group who are fungal-free and survive.	Day 90 (±7 days)
Noninferior Fungal-Free Survival (US FDA)	The percentage of subjects in each treatment group who are fungal-free and survive.	Day 90 (±7 days)
Superior Fungal-Free Survival (EMA)	The number of subjects in each treatment group who are fungal-free and survive.	Day 90 (±7 days)
Superior Fungal-Free Survival (EMA)	The percentage of subjects in each treatment group who are fungal-free and survive.	Day 90 (±7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 90 (±7 days)
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.	Day 90 (±7 days)
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.	Day 90 (±7 days)
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.	Day 90 (±7 days)
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.	Day 90 (±7 days)
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.	Day 90 (±7 days)
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).	Day 90 (±7 days)
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.	Day 1 through follow-up visit (Day 120)
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.	Day 1 through follow-up visit (Day 120)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Fungal-Free	The number of subjects in each treatment group who are fungal-free.	Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), and Day 120 (±7 days)
Comparison of Fungal-Free	The percentage of subjects in each treatment group who are fungal-free.	Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), and Day 120 (±7 days)
Comparison of Presence and Severity of GHVD	Evaluate the presence and severity of GVHD in subjects randomized to Rezafungin for Injection compared to the SAR.	Day 90 (±7 days)
Comparison of Fungal-Free with AML	The number of subjects in each treatment group who are fungal-free with an underlying diagnosis of acute myeloid leukemia (AML).	Day 90 (±7 days)
Comparison of Fungal-Free with AML	The percentage of subjects in each treatment group who are fungal-free with an underlying diagnosis of acute myeloid leukemia (AML).	Day 90 (±7 days)
Compare Incidence of IFD	Evaluate the incidence of proven, probable, possible, and presumptive IFD in subjects randomized to Rezafungin for Injection compared to the SAR.	Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days)
Compare Relapse-Free Survival	Evaluate relapse-free survival, with and without adjustment for patient comorbidity indices, in subjects randomized to Rezafungin for Injection compared to the SAR.	Day 1 through follow-up visit (Day 120)
Evaluate PK (Cmax)	Evaluate maximum plasma concentration (Cmax).	Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit
Evaluate PK (Tmax)	Evaluate time to Cmax.	Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit
Evaluate PK (AUC)	Evaluate area under the curve (AUC).	Day 0 (±2 days) within 10 minutes before end of infusion, and one sample between end of infusion and 12 hours after end of infusion; Days 1-4, one sample at any time; Day 7 (±1 day), Day 28 (±1 day), and Day 63 (±1 day) prior to dosing; and EOT visit
Compare Post-Engraftment Cytopenias and Transfusion Requirements	Evaluate post-engraftment cytopenias and transfusion requirements of Rezafungin for Injection compared to the SAR.	Day 1 through follow-up visit (Day 120)
Compare Infections Caused by TMP/SMX-Sensitive Organisms	Evaluate infections caused by TMP/SMX-sensitive organisms (Toxoplasma gondii [T. gondii], Nocardia spp.) in Rezafungin for Injection compared to the SAR.	Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days)
Compare Antifungal Prophylaxis	Evaluate interruption and discontinuation of antifungal prophylaxis due to suspected IFDs of Rezafungin for Injection compared to the SAR.	Day 14 (±1 day), Day 28 (±1 day), Day 60 (±5 days), Day 90 (±7 days), and Day 120 (±7 days)
Compare the health economics outcome research (HEOR) variable of "Days in Hospital"	Evaluate the number of hospital days for subjects randomized to Rezafungin for Injection compared to the SAR.	Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)]
Compare the health economics outcome research (HEOR) variable of "Days in Intensive Care Unit (ICU)"	Evaluate the number of days in ICU for subjects randomized to Rezafungin for Injection compared to the SAR.	Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)]
Compare the health economics outcome research (HEOR) variable of "Readmission due to Infectious Disease Diagnosis"	Evaluate readmission(s) due to infectious disease diagnosis for subjects randomized to Rezafungin for Injection compared to the SAR.	Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)]
Compare the health economics outcome research (HEOR) variable of "Readmission due to Invasive Fungal Disease Diagnosis"	Evaluate readmission(s) due to invasive fungal disease diagnosis for subjects randomized to Rezafungin for Injection compared to the SAR.	Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)]
Compare the health economics outcome research (HEOR) variable of "Alternative Antifungal Therapy"	Evaluate the incidence of alternative antifungal therapy compared to Rezafungin for Injection and the SAR.	Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)]
Compare the health economics outcome research (HEOR) variable of "Antibiotic Therapy"	Evaluate the incidence of antibiotic therapy compared to Rezafungin for Injection and the SAR.	Once weekly for outpatient, or twice weekly for inpatient, at completion of study drug therapy [Day 90 (±7 days)] and for 30 days [Day 120 (±7 days)]

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited
• Investigators: Study Director: Laura Cox, PhD, Mundipharma Research Limited

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): January 29, 2026
• Study Completion (Actual): January 29, 2026

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Infection; Pathologic Processes; Anti-Infective Agents; Invasive Fungal Infections; Fluconazole; Posaconazole; Caspofungin; Candidiasis; Sepsis; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Physiological Effects of Drugs; Systemic Inflammatory Response Syndrome; Candidemia; Antifungal Agents; Fungemia; Pneumocystis; Molecular Mechanisms of Pharmacological Action; Aspergillus; Mycoses; Prophylaxis of Invasive Fungal Infections; Candidiasis, Invasive; Blood and Marrow Transplant (BMT); Trimethoprim-sulfamethoxazole (TMP/SMX); Echinocandins; 14-alpha Demethylase Inhibitors; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Mold Infection; Rezafungin
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Bacterial Infections and Mycoses; Shock; Lung Diseases, Fungal; Pneumocystis Infections; Pathological Conditions, Signs and Symptoms; Invasive Fungal Infections; Inflammation; Sepsis; Infections; Pathologic Processes; Pneumonia, Pneumocystis; Mycoses; Systemic Inflammatory Response Syndrome; Candidiasis; Candidemia; Candidiasis, Invasive; Fungemia; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Therapeutics; Drug Administration Routes; Drug Therapy; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Aniline Compounds; Amines; Pyrimidines; Benzene Derivatives; Drug Combinations; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Sulfones; Trimethoprim; Triazoles; Rezafungin; Fluconazole; Trimethoprim, Sulfamethoxazole Drug Combination; Injections; posaconazole
• Other Study ID Numbers: CD101.IV.3.08; 2017-004981-85 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes