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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00412893
Other study ID # 9766-CL-0104
Secondary ID WSA-CS-0042006-0
Status Completed
Phase Phase 3
First received
Last updated
Start date March 7, 2007
Est. completion date March 28, 2013

Study information

Verified date March 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.


Description:

Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.


Recruitment information / eligibility

Status Completed
Enrollment 527
Est. completion date March 28, 2013
Est. primary completion date March 28, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi

- Female patients must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

- Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi

- Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction

- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary aspergillosis

- Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication

- Patients previously enrolled in a Phase III study with isavuconazole

- Patients with a body weight </= 40 kg

Study Design


Intervention

Drug:
Isavuconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Voriconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma
Argentina Instituto Medico Especializado Alexander Fleming Ciudad Autonoma
Australia Mater Medical Centre South Brisbane
Belgium AZ ST Jan Brugge
Belgium Institut Jules Bordet Brussels
Belgium ULB Hospital Erasme Bruxelles
Belgium Universitair Ziekenhuis Gent Gent
Belgium Universitaire Ziekenhuizen Leuven Leuven
Brazil Felicio Rocho Belo Horizonte
Brazil Santa Casa de Misericordia de Belo Horizonte Belo Horizonte
Brazil Hospital das Clinicas da UFPR Curitiba
Brazil Hospital de Clinicas da FMUSP - Ribeirao Preto Ribeirão Preto
Brazil Hospital Universitario Clementino Fraga Filho Rio de Janeiro
Canada Hamilton Health Sciences - Henderson Site Hamilton
Canada The Ottawa Hospital - General Campus Ottawa Ontario
Chile Hospital Dr. Hernan Henriquez Aravena Temuco
China 3rd Hospital, Peking University Beijing
China The 1st Hospital, Jilin University Changchun
China The Third Xiangya Hospital of Central South University Changsha
China West China Hospital of Sichuan University Chengdu
China The Affiliated Union Hospital of Fujian Medical University Fuzhou
China The First Affiliated Hospital, Med. School, Zhejiang Uni. Hangzhou
China The First Affiliated Hospital of Nanjing Medical University Nanjing
China The 1st Affiliated Hospital of Guangxi Medical University Nanning
China Chang Hai Hospital Shanghai
China Huashan Hospital, Insitute of Antibiotics Shanghai
China No.6 Renmin Hosp. of Shanghai City Shanghai
China Wuhan Union Hospital Wuhan
Egypt Alexandria University Hospital Alexandria
Egypt Nasser Institute Cairo
Egypt National Cancer Institute Cairo
France CHU de Nantes - Hôpital Hôtel Dieu Nantes Cedex
France Hotel Dieu Nantes Cedex 01
France Hôpital Hautepierre Strasbourg
France Hôpital de brabois adultes Vandoeuvre les Nancy
Germany Universitaetsklinikum Aachen Aachen
Germany Charité Universitaetsmedizin Berlin- Campus Charité Mitte Berlin
Germany Universitaet Koeln Köln
Germany Universitaetsklinik Leipzig Leipzig
Germany Klinikum Schwabing Muenchen
Germany Medizinische klinik und Polyklinik II Würzburg
Hungary Petz Aladar Megyei Oktato Korhaz Györ
Hungary Szegedi Tudomanyegyetem Szeged
India Sterling Hospital Ahmedabad Gujarat
India Apollo Hospitals Hyderabad Andh Prad
India Kasturba Medical College and Hospital Mangalore Karna
India Shirdi Sai Baba Cancer Hospital K. M. C. Hospital Manipal Karna
India Tata Memorial Hopital, Department of Anesthesia Mumbai Mahara
India Deenanath Mangeshkar Hospital & Research Centre Pune Mahara
India Sahyadri Hospital Pune Mahara
Israel Rambam Health Care Campus Haifa
Israel Hadassah Universtiy Hospital - Ein Kerem Jerusalem
Israel Rabin MC Petah Tikva
Israel Chaim Sheba Medical Center Ramat-Gan
Israel Sourasky MC Ichilov Hospital Tel Aviv Tel Aviv
Italy Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi Firenze
Italy Azienda Ospedaliera Ospedale Niguarda Ca' Granda Milano
Korea, Republic of Gachon University Gil Hospital Incheon
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of The Catholic University of Korea, St. Mary's Hospital Seoul
Mexico Hospital Universitario Dr Jose Eleuterio Gonzalez Monterrey
Poland Samodzielny Publiczny Centralny Szpital Kliniczny Warszawa
Russian Federation State Institution "Hematology Research Center" RAMS Moscow
Russian Federation Republican Hospital named after V.A. Baranov Petrozavodsk
Russian Federation Leningrad Regional Hospital St. Petersburg
Russian Federation St-Petersburg MA Postgraduate Education St. Petersburg
Thailand Songklanagarind Hospital Hat Yai
Thailand Maharaj Nakorn Chiang Mai Hospital Muang
Thailand Maharat Nakhon Ratchasima Hospital Muang
Thailand Srinagarind Hospital Muang
United States Upstate Infectious Diseases Association LLP Albany New York
United States University of Alabama Birmingham Alabama
United States Brigham & Womens Hospital Boston Massachusetts
United States University of Chicago, Division of Infectious Diseases Chicago Illinois
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Infectious Disease of Indiana Indianapolis Indiana
United States Regional Infection Diseases Infusion Center Inc. Lima Ohio
United States University of California at San Francisco San Francisco California
United States Indiana BMT Springfield Illinois
United States Springfield Clinic LLP Springfield Illinois

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Inc Basilea Pharmaceutica International Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  Egypt,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Spain,  Switzerland,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause Mortality Through Day 42 All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation. Through Day 42
Secondary Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC) The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.
Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).
End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death.
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary All-cause Mortality Through Day 84 All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation. Through Day 84
Secondary Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator Overall response based on investigators' assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10). Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Percentage of Participants With a Clinical Response Assessed by the DRC Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.
Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Percentage of Participants With a Mycological Response Assessed by the DRC Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.
Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as "Not Applicable".
End of treatment is the last day of study drug administration.
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Percentage of Participants With a Radiological Response Assessed by the DRC Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.
Radiological response is defined as a = 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Percentage of Participants With a Clinical Response Assessed by the Investigator Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.
Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Percentage of Participants With a Mycological Response Assessed by the Investigator Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.
Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as "Not Applicable".
End of treatment is the last day of study drug administration.
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Percentage of Participants With a Radiological Response Assessed by the Investigator Radiological assessments were performed by the investigator. Radiological response is defined as a = 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration. Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Secondary Number of Participants With Adverse Events, Reported by System Organ Class From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.
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