The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.
The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Topical Application
Sheila Fallon Friedlander, MD
San Diego, California, United States
David Rodriguez, MD
Coral Gables, Florida, United States
Lawrence Schachner, MD
Miami, Florida, United States
Wilson P. Andrews Jr., MD
Marietta, Georgia, United States
Number of Participants With Overall Cure (OC)
OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide \[KOH\] and culture results). Participants who had OC were categorized as "Successes"; those without OC were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Number of Participants With Clinical Cure
Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as "Successes"; those without clianical cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Number of Participants With Mycological Cure
Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as "Successes"; those without mycological cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode
The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild \[pink\]), 2 (moderate \[red\]), 3 (severe \[beefy red\]). Rating scale for Papules or Pustules: 0 (none to trace \[0\]), 1 (few \[1-10\]), 2 (multiple \[11-20\]), 3 (many \[21-40\]), 4 (abundant \[more than 40\]. Rating scale for Erosions: 0 (absent), 1 (present).
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Lewis Purnell, MD
San Antonio, Texas, United States
Daisy Blanco, MD
Santo Domingo, Dominican Republic
Manuel Briones, MD
Guayaquil, Ecuador
Zila Espinosa, MD
Panama City, Panama
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode
The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild \[pink\]), 2 (moderate \[red\]), 3 (severe \[beefy red\]). Rating scale for Papules or Pustules: 0 (none to trace \[0\]), 1 (few \[1-10\]), 2 (multiple \[11-20\]), 3 (many \[21-40\]), 4 (abundant \[more than 40\]. Rating scale for Erosions: 0 (absent), 1 (present).
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)
OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as "Successes"; those without OC were categorized as "Failures" (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication.
Time frame: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Number of Participants With Clinical Cure of First to Third Recurrent Episodes
Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as "Successes"; those without clinical cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
Time frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Number of Participants With Mycological Cure of First to Third Recurrent Episodes
Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as "Successes"; those without mycological cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
Time frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)