N/A
N=218
A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.
Invasive Aspergillosis · Mucormycosis
Bottom Line
View on ClinicalTrials.gov: NCT04550936 ↗Enrolled (actual)
218
Serious AEs
17.0%
Results posted
Dec 2025
Primary outcome: Primary: Number of Participants With Clinical Response at Week 6 — 173; 14; 27; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Isavuconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response at Week 6 |
173; 14; 27; 3; 1; 0 | — |
| PRIMARY Number of Participants With Clinical Response at Week 12 |
185; 15; 16; 2; 0; 0 | — |
| PRIMARY Number of Participants With Clinical Response at Week 24 |
193; 17; 8; 0; 0; 0 | — |
| PRIMARY Number of Participants With Radiological Response at Week 6 |
188; 14; 11; 3; 2; 0 | — |
| PRIMARY Number of Participants With Radiological Response at Week 12 |
190; 16; 9; 1; 2; 0 | — |
| PRIMARY Number of Participants With Radiological Response at Week 24 |
195; 16; 4; 0; 2; 1 | — |
| PRIMARY Number of Participants With Mycological Response at Week 6 |
190; 17; 7; 0; 4; 0 | — |
| PRIMARY Number of Participants With Mycological Response at Week 12 |
195; 17; 3; 0; 3; 0 | — |
| PRIMARY Number of Participants With Mycological Response at Week 24 |
198; 17; 1; 0; 0; 0 | — |
| PRIMARY All-Cause Mortality at Week 6 |
48; 1 | — |
| PRIMARY All-Cause Mortality at Week 12 |
74; 2 | — |
| PRIMARY All-Cause Mortality at Week 24 |
93; 5 | — |
| PRIMARY Number of Participants With Adverse Event at Week 6 |
33; 2 | — |
| PRIMARY Number of Participants With Adverse Event at Week 12 |
38; 3 | — |
| PRIMARY Number of Participants With Adverse Event at Week 24 |
42; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Event at Week 6 |
26; 2 | — |
| PRIMARY Number of Participants With Serious Adverse Event at Week 12 |
30; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Event at Week 24 |
34; 3 | — |
| SECONDARY Number of Participants According to Method of Administration |
105; 8; 92; 9; 4; 0 | — |
| SECONDARY Number of Participants According to Dosage of Isavuconazole Administration |
186; 17; 10; 0; 5; 0 | — |
| SECONDARY Number of Participants With Therapeutic Drug Monitoring (TDM) |
33; 4 | — |
| SECONDARY Number of Participants With Isavuconazole Treatment Modification |
24; 2 | — |
| SECONDARY Number of Participants With Types of Isavuconazole Treatment Modification |
15; 0; 14; 1; 13; 1 | — |
| SECONDARY Duration Between Isavuconazole Treatment and Treatment Modification |
38.6; 21.5 | — |
| SECONDARY Percentage of Participants Who Discontinued Isavuconazole Treatment |
93.0; 94.1 | — |
| SECONDARY Duration of Isavuconazole Treatment |
74.4; 115.6 | — |
| SECONDARY Number of Participants With Reasons for Isavuconazole Treatment Discontinuation |
75; 2; 40; 8; 33; 1 | — |
| SECONDARY Number of Participants Who Switched to New Antifungal |
34; 2 | — |
| SECONDARY Number of Participants With Type of New Antifungal Therapy |
12; 1; 10; 1; 6; 0 | — |
| SECONDARY Number of Participants With Isavuconazole Administered as Part of Combination Therapy |
53; 27 | — |
| SECONDARY Number of Participants Who Received Other Concomitant Treatments |
109; 16; 17; 2; 7; 2 | — |
| SECONDARY Number of Participants With Any Outpatient Visits |
87; 9 | — |
| SECONDARY Total Number of Outpatient Visits |
103; 12 | — |
| SECONDARY Type of Outpatient Visits |
70; 9; 15; 1; 6; 0 | — |
| SECONDARY Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit |
63.0; 82.6 | — |
| SECONDARY Number of Participants With Inpatient Hospitalization |
114; 14 | — |
| SECONDARY Number of Participants With Primary Reason For Inpatient Hospitalization |
83; 8; 31; 6; 27; 2 | — |
| SECONDARY Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization |
65.2; 77.2 | — |
| SECONDARY Mean Length of Stay For Inpatient Hospitalization |
20.8; 20.0 | — |
| SECONDARY Number of Participants According to Location for Inpatient Hospitalization |
61; 6; 40; 5; 21; 1 | — |
Summary
This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
Eligibility Criteria
Inclusion Criteria
- Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
- Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )
- Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)
Exclusion Criteria
- Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period
Data sourced from ClinicalTrials.gov (NCT04550936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.