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Trial record 11 of 12 for:    "Tinea Unguium" | "Cytochrome P-450 Enzyme Inhibitors"

Anti-mold Azole in the Prophylaxis for Invasive Fusariosis (Fusarproph)

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ClinicalTrials.gov Identifier: NCT02714504
Recruitment Status : Completed
First Posted : March 21, 2016
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Marcio Nucci, Universidade Federal do Rio de Janeiro

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Fusariosis
Onychomycosis
Intervention Drug: Voriconazole or posaconazole
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observational Anti-mold Prophylaxis
Hide Arm/Group Description No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions

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

Period Title: Overall Study
Started 61 178
Completed 61 178
Not Completed 0 0
Arm/Group Title Observational Anti-mold Prophylaxis Total
Hide Arm/Group Description No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions

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 of all reporting groups
Overall Number of Baseline Participants 61 178 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Age Number Analyzed 61 participants 178 participants 239 participants
44
(14 to 66)
50
(13 to 72)
48
(13 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 178 participants 239 participants
Female
37
  60.7%
109
  61.2%
146
  61.1%
Male
24
  39.3%
69
  38.8%
93
  38.9%
1.Primary Outcome
Title Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery
Hide Description Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks
Time Frame Until neutrophil recovery, for an average of 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Observational Anti-mold Prophylaxis
Hide Arm/Group Description:
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions

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 Number of Participants Analyzed 61 178
Measure Type: Count of Participants
Unit of Measure: Participants
6
   9.8%
8
   4.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Observational Anti-mold Prophylaxis
Hide Arm/Group Description No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions

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

All-Cause Mortality
Observational Anti-mold Prophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   11/61 (18.03%)   18/178 (10.11%) 
Show Serious Adverse Events Hide Serious Adverse Events
Observational Anti-mold Prophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/178 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Observational Anti-mold Prophylaxis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/178 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Marcio Nucci
Organization: Univ Fed Rio de Janeiro
Phone: 552139382463
EMail: mnucci@hucff.ufrj.br
Layout table for additonal information
Responsible Party: Marcio Nucci, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02714504     History of Changes
Other Study ID Numbers: Fusarium prophylaxis
First Submitted: March 8, 2016
First Posted: March 21, 2016
Results First Submitted: January 23, 2018
Results First Posted: September 21, 2018
Last Update Posted: September 21, 2018