Trial Outcomes & Findings for Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients (NCT NCT03378479)

NCT ID: NCT03378479

Last Updated: 2025-04-08

Results Overview

A patient with IAA-infection is defined as a patient having mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 88 participants
• Primary outcome timeframe: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
• Results posted on: 2025-04-08

Participant Flow

Participant milestones

Measure	SOC + 'Posaconazole 18 Milligram/Milliliter' standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d intravenously (IV) on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Overall Study STARTED	43	45
Overall Study COMPLETED	37	36
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients

Baseline characteristics by cohort

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	20 Participants n=4 Participants	45 Participants n=27 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants	16 Participants n=4 Participants	28 Participants n=27 Participants
Age, Continuous	59 years STANDARD_DEVIATION 16 • n=93 Participants	63 years STANDARD_DEVIATION 15 • n=4 Participants	61 years STANDARD_DEVIATION 15 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	18 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	18 Participants n=4 Participants	41 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	37 Participants n=93 Participants	36 Participants n=4 Participants	73 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=93 Participants	9 Participants n=4 Participants	20 Participants n=27 Participants
Region of Enrollment Netherlands	1 participants n=93 Participants	4 participants n=4 Participants	5 participants n=27 Participants
Region of Enrollment Belgium	34 participants n=93 Participants	27 participants n=4 Participants	61 participants n=27 Participants
Region of Enrollment France	2 participants n=93 Participants	5 participants n=4 Participants	7 participants n=27 Participants

PRIMARY outcome

Timeframe: from date of admission in ICU assessed up to ICU discharge, approximately 21 days

A patient with IAA-infection is defined as a patient having mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Number of Participants With IAA-infection at ICU Discharge	2 Participants	4 Participants

SECONDARY outcome

Timeframe: from date of inclusion to date of first sign/symptom of IAA infection, assessed up to ICU discharge, approximately 10 days

Population: Calculated for the patients with IAPA 2 patients in SOC + 'Posaconazole 18 mg/ml' group 4 patients in SOC group

Days to influenza-associated pulmonary aspergillosis (IAPA) diagnosis

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=2 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=4 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Time to IAPA Diagnosis	10 days Interval 8.0 to 12.0	5 days Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: from date of admission in ICU to date of discharge from ICU, approximately 20 days

Population: Length of stay was defined as the time to discharge alive, while death was considered as a competing event. 7 patients died in SOC + POS group (37-7=30) 9 patient died in SOC group (36-9=27)

amount of days at ICU

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=30 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=27 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Length of ICU Stay	16 days Interval 8.0 to 29.0	6 days Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: from date of admission in hospital to date of discharge from hospital, approximately 25 days

Population: Length of stay was defined as the time to discharge alive, while death was considered as a competing event. 9 patients died in SOC + POS group (37-9=28) 11 patients died in SOC group (37-11=25)

Number of days in the hospital

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=28 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=25 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Length of Hospital Stay	25 days Interval 18.0 to 45.0	12 days Interval 9.0 to 35.0

SECONDARY outcome

Timeframe: At ICU discharge

survival status

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
ICU Mortality - Number of Participant Deaths	7 Participants	9 Participants

SECONDARY outcome

Timeframe: At hospital discharge

Survival status at hospital discharge

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Hospital Mortality - Number of Participant Deaths	8 Participants	10 Participants

SECONDARY outcome

Timeframe: At 90 days after ICU admission

Survival status at 90 days after ICU admission

Outcome measures

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 Participants standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 Participants standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
90-day Mortality - Number of Participant Deaths	9 Participants	11 Participants

Adverse Events

SOC + 'Posaconazole 18 MG/ML'

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Standard of Care

Serious events: 11 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 participants at risk standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 participants at risk standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Infections and infestations Death	24.3% 9/37 • 90 days after ICU admission Adverse events at the ICU department are very hard to define. SAE were documented. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	30.6% 11/36 • 90 days after ICU admission Adverse events at the ICU department are very hard to define. SAE were documented. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Other adverse events

Measure	SOC + 'Posaconazole 18 MG/ML' n=37 participants at risk standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total) SOC +Posaconazole 18 MG/ML (milligram/milliliter): .2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion	Standard of Care n=36 participants at risk standard of care treatment for influenza pneumonia (at the investigators discretion) standard of care (SOC): treatment for influenza pneumonia at the investigators discretion
Infections and infestations Explanation	— 0/0 • 90 days after ICU admission Adverse events at the ICU department are very hard to define. SAE were documented. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	— 0/0 • 90 days after ICU admission Adverse events at the ICU department are very hard to define. SAE were documented. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Additional Information

Prof. Dr. Joost Wauters - Intensivist

UZ Leuven

Phone: 016344275

Email: joost.wauters@uzleuven.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place