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Cresemba® dans le traitement des patients chinois atteints d'IFD causée par des espèces d'Aspergillus ou d'autres champignons filamenteux

26 mai 2026 mis à jour par: Pfizer

UNE ÉTUDE PROSPECTIVE MULTICENTRE À UN SEUL BRAS VISANT À ÉVALUER LA SÉCURITÉ ET L'EFFICACITÉ DE L'ISAVUCONAZOLE POUR LE TRAITEMENT PRIMAIRE DES PATIENTS CHINOIS ATTEINTS D'UNE MALADIE FONGIQUE INVASIVE (MFI) CAUSÉE PAR DES ESPÈCES ASPERGILLES OU D'AUTRES CHAMPIGNONS FILAMENTEUX

Cette étude est une étude d'engagement post-approbation et est conçue pour évaluer davantage l'innocuité et l'efficacité de l'isavuconazole dans une population chinoise relativement plus importante qui recevra un traitement à l'isavuconazole dans un contexte post-commercialisation.

Il s'agit d'une étude prospective multicentrique à un seul bras. Cette étude recherche des patients chinois atteints d'une maladie fongique invasive (IFD) avérée, probable ou possible causée par des espèces d'Aspergillus ou d'autres champignons filamenteux. Tous les participants recevront un traitement à l'isavuconazole. La durée de traitement la plus longue dans cette étude est de 84 jours (jusqu'à 180 jours pour les participants diagnostiqués avec la MI).

L'objectif principal est de caractériser l'innocuité et la tolérabilité de l'isavuconazole en observant les événements indésirables survenus pendant le traitement.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

70

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
      • Beijing, Chine, 100044
        • Peking University People's Hospital
      • Bengbu, Chine, 233000
        • the First Affiliated Hospital of Bengbu Medical College
      • Shanghai, Chine, 201800
        • Jiading Central Hospital
    • Anhui
      • Hefei, Anhui, Chine, 230001
        • The First Affiliated Hospital of USTC, Anhui Province Hospital
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, Chine, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, Chine, 510280
        • ZhuJiang Hospital of Southern Medical University
      • Jieyang, Guangdong, Chine, 522095
        • Jieyang People's Hospital
    • Henan
      • Zhengzhou, Henan, Chine, 450003
        • Henan Provincial People's Hospital
    • Shandong
      • Liaocheng, Shandong, Chine, 252000
        • Liaocheng People's Hospital
      • Zibo, Shandong, Chine, 255036
        • Zibo Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200040
        • Huashan Hospital, Fudan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine, 300020
        • Institute of Hematology, Chinese Academy of Medical Sciences
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310003
        • The First Affiliated Hospital Zhejiang University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • IFD prouvée, probable ou possible causée par des espèces d'Aspergillus, des espèces de Mucorales ou d'autres champignons filamenteux
  • poids corporel> 40 kg au dépistage

Critère d'exclusion:

  • soit aspergillose chronique, aspergillome ou ABPA
  • Infection à VIH avancée avec un nombre de CD4 < 200 ou une condition définissant le syndrome d'immunodéficience acquise
  • les personnes qui ont peu de chances de survivre 5 jours ou les participants sous ventilation mécanique
  • insuffisance hépatique sévère (Child-Pugh Classe C)
  • syndrome du QT court familial
  • Utilisation concomitante d'efavirenz, de ritonavir, d'étravirine, de rifampicine/rifampicine, de rifabutine, de nafcilline, de kétoconazole ou de millepertuis dans les 5 jours précédant la première administration de l'intervention à l'étude

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Isavuconazole
Il s'agit d'une étude à un seul bras, tous les participants inscrits recevront le médicament à l'étude.
Médicament: Isavuconazole
Il s'agit d'une étude à un seul bras, tous les participants inscrits recevront l'intervention de l'étude.
Autres noms:
  • Cresemba®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
All-cause Mortality Rate Through Day 42
Délai: After first dose of study intervention (Day 1) through Day 42
All-cause mortality included any death that occurred after first dose of study drug through Day 42 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 42 and b) unknown deaths: unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 42. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths [actual] and unknown deaths [not actual but treated as deaths]) among the overall number of participants analyzed.
After first dose of study intervention (Day 1) through Day 42
All-cause Mortality Rate Through Day 84
Délai: After first dose of study intervention (Day 1) through Day 84
All-cause mortality included any death that occurred after first dose of study drug through Day 84 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 84 and b) unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 84. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths [actual] and unknown deaths [not actual but treated as deaths]) among the overall number of participants analyzed.
After first dose of study intervention (Day 1) through Day 84
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
Délai: Day 42, Day 84 and EOT (any day before or at Day 180)
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for:a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings;b)A success radiological response means:1) greater than equal to(>=) 90 percent (%)improvement from screening,2)>= 50% to less than(<)90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)>=25% to <50% improvement from screening (For Day 42 and EOT (that is before Day 180) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c)mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 180)
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
Délai: Day 42, Day 84 and EOT (any day before or at Day 84)
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for: a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings; b)A success radiological response means:1) >= 90 percent (%)improvement from screening, 2)>= 50% to < 90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)>=25% to <50% improvement from screening (For Day 42 and EOT (that is before Day 84) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c) mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 84)
Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
Délai: Day 42, Day 84 and EOT (any day before or at Day 180)
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 180)
Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Délai: Day 42, Day 84 and EOT (any day before or at Day 84)
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success among all evaluable participants (excluding assessment not applicable participants) at specified time points. Clinical success rate: percentage of participants with clinical success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 84)
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
Délai: Day 42, Day 84 and EOT (any day before or at Day 180)
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 180)
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Délai: Day 42, Day 84 and EOT (any day before or at Day 84)
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 84)
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
Délai: Day 42, Day 84 and EOT (any day or at before Day 180)
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) >=90% improvement from screening, (2) >=50% to <90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) >=25% to <50% improvement from screening for Day 42 and EOT (that is before Day 180). Success rate: percentage of participants with successful radiological response at specified time points.
Day 42, Day 84 and EOT (any day or at before Day 180)
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Délai: Day 42, Day 84 and EOT (any day before Day 84)
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) >=90% improvement from screening, (2) >=50% to <90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) >=25% to <50% improvement from screening for Day 42 and EOT (that is before Day 84). Success rate: percentage of participants with successful radiological response at specified time points.
Day 42, Day 84 and EOT (any day before Day 84)
Number of Participants With Treatment Related TEAEs
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. Treatment related TEAEs were TEAEs related to study intervention. AEs included both serious and all non-SAEs.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, is life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was a congenital anomaly/birth defect. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With TEAEs Leading to Study Intervention Discontinuation
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. In this outcome measure, number of participants with TEAEs leading to study intervention discontinuation (during study treatment) were reported.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With TEAEs Leading to Death
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. In this outcome measure, number of participants with TEAEs leading to death (during study treatment) were reported.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Death
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of participants with death due to any cause were reported in this outcome measure.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Laboratory Test Abnormalities
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Clinical laboratory abnormalities test criteria included, a) hematology: hemoglobin with primary criteria of <0.8* lower limit of normal (LLN), erythrocytes <0.8* LLN, platelets <0.5* LLN >1.75* upper limit of normal (ULN), leukocytes < 0.6* LLN and > 1.5* ULN, lymphocytes and neutrophils < 0.8* LLN and > 1.2* ULN. b) Chemistry: bilirubin and direct bilirubin >1.5* ULN, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase >3.0* ULN, urea nitrogen, urea and creatinine >1.3* ULN, sodium <0.95* LLN and potassium<0.9* LLN. c) urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin and bilirubin, urobilinogen, nitrite leukocyte esterase >= 1. Number of participants with any laboratory abnormalities were reported in this outcome measure.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Vital signs included systolic and diastolic blood pressures and pulse rate. Clinical significance of vital signs was judged by the investigator.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Predefined ECG criteria of clinical significance: a) heart rate (beats per minute [bpm]): value <40 and value >120; b) PR interval (millisecond [(msec)]: value>280; c) QRS interval (msec): value>120 d) QTc corrected using Fridericia's formula (QTcF) (msec): value >500 and new prolongation value >480 or increase >= 60. Only those pre-defined ECG categories for which non-zero data were available have been reported below.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Abnormal Eye Examination
Délai: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
The eye examination included visual acuity, confrontational visual field testing and color perception testing. Any abnormality was assessed by a qualified ophthalmologist.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Délai: Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)
Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Les enquêteurs

  • Directeur d'études: Pfizer CT.gov Call Center, Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 février 2023

Achèvement primaire (Réel)

11 avril 2025

Achèvement de l'étude (Réel)

11 avril 2025

Dates d'inscription aux études

Première soumission

18 novembre 2022

Première soumission répondant aux critères de contrôle qualité

18 novembre 2022

Première publication (Réel)

30 novembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • C3791001
  • NCT05630976 (Identificateur de registre: ClinicalTrials.gov)

Plan pour les données individuelles des participants (IPD)

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OUI

Description du régime IPD

Pfizer fournira un accès aux données personnelles anonymisées des participants et aux documents d'étude connexes (par ex. protocole, plan d'analyse statistique (PAS), rapport d'étude clinique (CSR)) sur demande de chercheurs qualifiés, et sous réserve de certains critères, conditions et exceptions. De plus amples détails sur les critères de partage des données de Pfizer et le processus de demande d'accès sont disponibles sur : https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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