Trial Outcomes & Findings for Anti-mold Azole in the Prophylaxis for Invasive Fusariosis (NCT NCT02714504)
NCT ID: NCT02714504
Last Updated: 2018-09-21
Results Overview
Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
239 participants
Primary outcome timeframe
Until neutrophil recovery, for an average of 4 weeks
Results posted on
2018-09-21
Participant Flow
Participant milestones
| Measure |
Observational
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
|
Anti-mold Prophylaxis
Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Voriconazole or posaconazole: Azole with activity against molds
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
178
|
|
Overall Study
COMPLETED
|
61
|
178
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-mold Azole in the Prophylaxis for Invasive Fusariosis
Baseline characteristics by cohort
| Measure |
Observational
n=61 Participants
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
|
Anti-mold Prophylaxis
n=178 Participants
Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Voriconazole or posaconazole: Azole with activity against molds
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
44 years
n=5 Participants
|
50 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until neutrophil recovery, for an average of 4 weeksProportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks
Outcome measures
| Measure |
Observational
n=61 Participants
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
|
Anti-mold Prophylaxis
n=178 Participants
Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Voriconazole or posaconazole: Azole with activity against molds
|
|---|---|---|
|
Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery
|
6 Participants
|
8 Participants
|
Adverse Events
Observational
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Anti-mold Prophylaxis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place