NCT00634049 (VITAL) is a Phase 3 clinical trial of isavuconazole in Aspergillosis, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT00634049?

NCT00634049 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT00634049?

Interventions in NCT00634049: isavuconazole.

What condition does NCT00634049 study?

NCT00634049 studies Aspergillosis, Invasive Fungal Infections.

Is NCT00634049 still recruiting?

NCT00634049 is currently completed. Last updated 11 December 2024.

Are results published for NCT00634049?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-11 · How we verify

NCT00634049: VITAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Completed Phase 3 Results posted Last updated 11 December 2024

What this trial tests

Phase 3 trial testing isavuconazole in Aspergillosis in 149 participants. Completed in 5 May 2016.

Timeline

22 April 2008

Primary endpoint
3 January 2014

5 May 2016

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	149
Start date	22 April 2008
Primary completion	3 January 2014
Estimated completion	5 May 2016
Sites	96 locations across Poland, South Korea, Lebanon, Russia, Belgium, Mexico, Thailand, United States

Drugs / interventions tested

isavuconazole (isavuconazole) — full drug profile →

Conditions studied

Aspergillosis — all drugs for Aspergillosis →
Invasive Fungal Infections — all drugs for Invasive Fungal Infections →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, any sex, with Aspergillosis or Invasive Fungal Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). Primary · Day 42, 84 and End of Treatment (EOT [Day 180])

The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Day 42- Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	25.0
mITT - Aspergillus [Not Renally Impaired]	50.0
mITT - Mucorales (Primary Therapy)	14.3
mITT - Mucorales (Refractory)	9.1
mITT - Mucorales (Intolerant)	0
mITT- Other Filamentous Fungi	47.1
mITT- Other Mould Species Only	28.6
mITT- Other Dimorphic Fungi	41.4
mITT- Other Non-Candida Yeast	36.4
mITT-Other Mixed Infection	13.3

Day 84 - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	30.0
mITT - Aspergillus [Not Renally Impaired]	25.0
mITT - Mucorales (Primary Therapy)	9.5
mITT - Mucorales (Refractory)	36.4
mITT - Mucorales (Intolerant)	20.0
mITT- Other Filamentous Fungi	41.2
mITT- Other Mould Species Only	28.6
mITT- Other Dimorphic Fungi	44.8
mITT- Other Non-Candida Yeast	36.4
mITT-Other Mixed Infection	13.3

End of Treatment (EOT) - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	30.0
mITT - Aspergillus [Not Renally Impaired]	66.7
mITT - Mucorales (Primary Therapy)	31.6
mITT - Mucorales (Refractory)	36.4
mITT - Mucorales (Intolerant)	20.0
mITT- Other Filamentous Fungi	64.7
mITT- Other Mould Species Only	28.6
mITT- Other Dimorphic Fungi	64.3
mITT- Other Non-Candida Yeast	72.7
mITT-Other Mixed Infection	14.3

Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT Secondary · Day 42, 84 and End of Treatment (EOT [Day 180])

The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success \[Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Day 42- Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	55.0
mITT - Aspergillus [Not Renally Impaired]	75.0
mITT - Mucorales (Primary Therapy)	50.0
mITT - Mucorales (Refractory)	33.3
mITT - Mucorales (Intolerant)	50.0
mITT-Other Filamentous Fungi	68.8
mITT- Other Mould Species Only	71.4
mITT- Other Dimorphic Fungi	79.3
mITT- Other Non-Candida Yeast	70.0
mITT-Other Mixed Infection	42.9

Day 84 - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	45.0
mITT - Aspergillus [Not Renally Impaired]	25.0
mITT - Mucorales (Primary Therapy)	40.0
mITT - Mucorales (Refractory)	22.2
mITT - Mucorales (Intolerant)	50.0
mITT-Other Filamentous Fungi	62.5
mITT- Other Mould Species Only	42.9
mITT- Other Dimorphic Fungi	82.8
mITT- Other Non-Candida Yeast	70.0
mITT-Other Mixed Infection	35.7

End of Treatment (EOT) - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	55.0
mITT - Aspergillus [Not Renally Impaired]	66.7
mITT - Mucorales (Primary Therapy)	55.6
mITT - Mucorales (Refractory)	22.2
mITT - Mucorales (Intolerant)	50.0
mITT-Other Filamentous Fungi	81.3
mITT- Other Mould Species Only	85.7
mITT- Other Dimorphic Fungi	82.1
mITT- Other Non-Candida Yeast	70.0
mITT-Other Mixed Infection	38.5

Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT Secondary · Day 42, 84 and End of Treatment (EOT [Day 180])

The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success \[Eradication and Presumed eradication\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Day 42- Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	30.0
mITT - Aspergillus [Not Renally Impaired]	50.0
mITT - Mucorales (Primary Therapy)	4.8
mITT - Mucorales (Refractory)	0
mITT - Mucorales (Intolerant)	0
mITT-Other Filamentous Fungi	29.4
mITT- Other Mould Species Only	28.6
mITT- Other Dimorphic Fungi	27.6
mITT- Other Non-Candida Yeast	45.5
mITT-Other Mixed Infection	13.3

Day 84 - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	35.0
mITT - Aspergillus [Not Renally Impaired]	25.0
mITT - Mucorales (Primary Therapy)	9.5
mITT - Mucorales (Refractory)	27.3
mITT - Mucorales (Intolerant)	40.0
mITT-Other Filamentous Fungi	35.3
mITT- Other Mould Species Only	28.6
mITT- Other Dimorphic Fungi	27.6
mITT- Other Non-Candida Yeast	45.5
mITT-Other Mixed Infection	13.3

End of Treatment (EOT) - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	35.0
mITT - Aspergillus [Not Renally Impaired]	66.7
mITT - Mucorales (Primary Therapy)	31.6
mITT - Mucorales (Refractory)	36.4
mITT - Mucorales (Intolerant)	40.0
mITT-Other Filamentous Fungi	70.6
mITT- Other Mould Species Only	28.6
mITT- Other Dimorphic Fungi	53.6
mITT- Other Non-Candida Yeast	81.8
mITT-Other Mixed Infection	14.3

Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT Secondary · Day 42, 84 and End of Treatment (EOT [Day 180])

The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success \[Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections\], \[Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections\]; and \[Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections\]. End of treatment (EO

Day 42- Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	30.0
mITT - Aspergillus [Not Renally Impaired]	25.0
mITT - Mucorales (Primary Therapy)	0
mITT - Mucorales (Refractory)	10.0
mITT - Mucorales (Intolerant)	0
mITT-Other Filamentous Fungi	25.0
mITT- Other Mould Species Only	16.7
mITT- Other Dimorphic Fungi	21.4
mITT- Other Non-Candida Yeast	0
mITT-Other Mixed Infection	7.1

Day 84 - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	20.0
mITT - Aspergillus [Not Renally Impaired]	25.0
mITT - Mucorales (Primary Therapy)	4.8
mITT - Mucorales (Refractory)	20.0
mITT - Mucorales (Intolerant)	20.0
mITT-Other Filamentous Fungi	6.3
mITT- Other Mould Species Only	0
mITT- Other Dimorphic Fungi	28.6
mITT- Other Non-Candida Yeast	10.0
mITT-Other Mixed Infection	14.3

End of Treatment (EOT) - Success Rate

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	15.0
mITT - Aspergillus [Not Renally Impaired]	66.7
mITT - Mucorales (Primary Therapy)	16.7
mITT - Mucorales (Refractory)	20.0
mITT - Mucorales (Intolerant)	20.0
mITT-Other Filamentous Fungi	50.0
mITT- Other Mould Species Only	0
mITT- Other Dimorphic Fungi	33.3
mITT- Other Non-Candida Yeast	10.0
mITT-Other Mixed Infection	7.7

Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT Secondary · Day 42, Day 84 and End of Treatment (EOT [Day 180])

The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success \[Resolution of all attributable clinical symptoms and physical findings\] and \[Resolution of some attributable clinical symptoms and physical findings\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Day 42

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	60.0
mITT - Aspergillus [Not Renally Impaired]	75.0
mITT - Mucorales (Primary Therapy)	50.0
mITT - Mucorales (Refractory)	28.6
mITT - Mucorales (Intolerant)	25.0
mITT- Other Filamentous Fungi	81.3
mITT- Other Mould Species Only	85.7
mITT- Other Dimorphic Fungi	75.9
mITT- Other Non-Candida Yeast	70.0
mITT-Other Mixed Infection	50.0

Day 84

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	55.0
mITT - Aspergillus [Not Renally Impaired]	55.0
mITT - Mucorales (Primary Therapy)	21.4
mITT - Mucorales (Refractory)	25.0
mITT - Mucorales (Intolerant)	20.0
mITT- Other Filamentous Fungi	62.5
mITT- Other Mould Species Only	42.9
mITT- Other Dimorphic Fungi	82.2
mITT- Other Non-Candida Yeast	70.0
mITT-Other Mixed Infection	35.7

End of Treatment (EOT)

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	60.0
mITT - Aspergillus [Not Renally Impaired]	75.0
mITT - Mucorales (Primary Therapy)	42.9
mITT - Mucorales (Refractory)	28.6
mITT - Mucorales (Intolerant)	66.7
mITT- Other Filamentous Fungi	81.3
mITT- Other Mould Species Only	71.4
mITT- Other Dimorphic Fungi	79.3
mITT- Other Non-Candida Yeast	70.0
mITT-Other Mixed Infection	42.9

Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT Secondary · Day 42, Day 84 and End of Treatment (EOT [Day 180])

The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success \[Eradication,Presumed eradication\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Day 42

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	46.7
mITT - Aspergillus [Not Renally Impaired]	66.7
mITT - Mucorales (Primary Therapy)	50.0
mITT - Mucorales (Refractory)	28.6
mITT - Mucorales (Intolerant)	25.0
mITT- Other Filamentous Fungi	69.2
mITT- Other Mould Species Only	83.3
mITT- Other Dimorphic Fungi	70.6
mITT- Other Non-Candida Yeast	50.0
mITT-Other Mixed Infection	18.2

Day 84

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	44.4
mITT - Aspergillus [Not Renally Impaired]	50.0
mITT - Mucorales (Primary Therapy)	21.4
mITT - Mucorales (Refractory)	25.0
mITT - Mucorales (Intolerant)	20.0
mITT- Other Filamentous Fungi	64.3
mITT- Other Mould Species Only	42.9
mITT- Other Dimorphic Fungi	80.0
mITT- Other Non-Candida Yeast	25.0
mITT-Other Mixed Infection	33.3

End of Treatment (EOT)

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	50.0
mITT - Aspergillus [Not Renally Impaired]	66.7
mITT - Mucorales (Primary Therapy)	42.9
mITT - Mucorales (Refractory)	28.6
mITT - Mucorales (Intolerant)	66.7
mITT- Other Filamentous Fungi	78.6
mITT- Other Mould Species Only	66.7
mITT- Other Dimorphic Fungi	76.9
mITT- Other Non-Candida Yeast	50.0
mITT-Other Mixed Infection	25.0

Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT Secondary · Day 42, Day 84 and End of Treatment (EOT [Day 180])

The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success \[≥ 90% improvement,≥ 50% to \< 90% improvement and ≥ 25% to \< 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

Day 42

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	35.0
mITT - Aspergillus [Not Renally Impaired]	75.0
mITT - Mucorales (Primary Therapy)	40.0
mITT - Mucorales (Refractory)	0
mITT - Mucorales (Intolerant)	40.0
mITT- Other Filamentous Fungi	46.7
mITT- Other Mould Species Only	20.0
mITT- Other Dimorphic Fungi	32.1
mITT- Other Non-Candida Yeast	9.1
mITT-Other Mixed Infection	28.6

Day 84

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	40.0
mITT - Aspergillus [Not Renally Impaired]	50.0
mITT - Mucorales (Primary Therapy)	25.0
mITT - Mucorales (Refractory)	11.1
mITT - Mucorales (Intolerant)	40.0
mITT- Other Filamentous Fungi	40.0
mITT- Other Mould Species Only	20.0
mITT- Other Dimorphic Fungi	37.0
mITT- Other Non-Candida Yeast	0
mITT-Other Mixed Infection	7.1

End of Treatment (EOT)

Group	Value	95% CI
mITT - Aspergillus [Renally Impaired]	35.0
mITT - Aspergillus [Not Renally Impaired]	50.0
mITT - Mucorales (Primary Therapy)	30.0
mITT - Mucorales (Refractory)	22.2
mITT - Mucorales (Intolerant)	20.0
mITT- Other Filamentous Fungi	33.3
mITT- Other Mould Species Only	40.0
mITT- Other Dimorphic Fungi	55.6
mITT- Other Non-Candida Yeast	10.0
mITT-Other Mixed Infection	14.3

All-cause Mortality Through Day 42 and Day 84 Secondary · Baseline to End of Treatment (EOT [Day 180])

All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

All-cause Mortality Through Day 42

Group	Value	95% CI
Renally Impaired	22.0
Not Renally Impaired	16.1

All-cause Mortality Through Day 84

Group	Value	95% CI
Renally Impaired	30.5
Not Renally Impaired	20.7

Safety - Overall Number of TEAEs Secondary · From the first study drug administration until 28 days after the last dose of study drug

A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.

TEAEs

Group	Value	95% CI
Isavuconazole	139

Study Drug-Related TEAEs

Group	Value	95% CI
Isavuconazole	60

Serious TEAEs

Group	Value	95% CI
Isavuconazole	89

Study Drug-Related Serious TEAEs

Group	Value	95% CI
Isavuconazole	13

TEAEs Leading to Permanent Discontinuation of Stud

Group	Value	95% CI
Isavuconazole	19

Study Drug TEAEs Leading to Perm Discontinuation

Group	Value	95% CI
Isavuconazole	7

TEAEs Leading to Death

Group	Value	95% CI
Isavuconazole	44

Study Drug-Related TEAEs Leading to Death

Group	Value	95% CI
Isavuconazole	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Renally Impaired (RI)

Serious: 43/59 (73%)

Deaths: —

Not Renally Impaired (NRI)

Serious: 46/87 (53%)

Deaths: —

Serious adverse events (139 terms)

Reaction	System	Renally Impaired (RI)	Not Renally Impaired (NRI)
Pneumonia	Infections and infestations	—	—
Septic shock	Infections and infestations	—	—
Renal failure acute	Renal and urinary disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Bacteraemia	Infections and infestations	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Death	General disorders	—	—
Acute graft versus host disease	Immune system disorders	—	—
Aspergillosis	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Mucormycosis	Infections and infestations	—	—
Pneumonia bacterial	Infections and infestations	—	—
Pneumonia fungal	Infections and infestations	—	—
Pseudomonal sepsis	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Zygomycosis	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (52 terms — click to expand)

Reaction	System	Renally Impaired (RI)	Not Renally Impaired (NRI)
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Headache	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—
Confusional state	Psychiatric disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Chills	General disorders	—	—
Herpes zoster	Infections and infestations	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Hypertension	Vascular disorders	—	—
Hypotension	Vascular disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Fatigue	General disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Haematochezia	Gastrointestinal disorders	—	—

Most-reported serious reactions: Pneumonia, Septic shock, Renal failure acute, Vomiting, Respiratory failure, Abdominal pain, Gastrointestinal haemorrhage, Bacteraemia.

Data from ClinicalTrials.gov NCT00634049 adverse events section.

Sponsor's own description

The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis.
Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, et al · · 2016 · cited 479× · PMID 26969258 · DOI 10.1016/s1473-3099(16)00071-2
Chromoblastomycosis.
Queiroz-Telles F, de Hoog S, Santos DW, Salgado CG, et al · · 2017 · cited 208× · PMID 27856522 · DOI 10.1128/cmr.00032-16
Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses.
Thompson GR, Rendon A, Ribeiro Dos Santos R, Queiroz-Telles F, et al · · 2016 · cited 134× · PMID 27169478 · DOI 10.1093/cid/ciw305
Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study.
Cornely OA, Böhme A, Schmitt-Hoffmann A, Ullmann AJ. · · 2015 · cited 82× · PMID 25624327 · DOI 10.1128/aac.04569-14
Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections.
Falci DR, Pasqualotto AC. · · 2013 · cited 73× · PMID 24187505 · DOI 10.2147/idr.s51340
Isavuconazole (BAL4815) pharmacodynamic target determination in an in vivo murine model of invasive pulmonary aspergillosis against wild-type and cyp51 mutant isolates of Aspergillus fumigatus.
Lepak AJ, Marchillo K, Vanhecker J, Andes DR. · · 2013 · cited 70× · PMID 24100500 · DOI 10.1128/aac.01355-13
Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study).
Kovanda LL, Desai AV, Lu Q, Townsend RW, et al · · 2016 · cited 54× · PMID 27185799 · DOI 10.1128/aac.00514-16
Isavuconazole for the treatment of patients with invasive fungal diseases involving the central nervous system.
Schwartz S, Cornely OA, Hamed K, Marty FM, et al · · 2020 · cited 53× · PMID 31613363 · DOI 10.1093/mmy/myz103

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00634049 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 11 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00634049.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00634049: VITAL

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (139 terms)

Sponsor's own description

Publications & conference data

Related trials

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Other Astellas Pharma Inc trials

Verify against primary sources