Clinical Trial: Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective 2-Year Longitudinal Study to Assess for Miconazole Resistance in Candida Spp. With Repeated Treatment Courses of 0.25% Miconazole Nitrate Ointment in Neonates and Infants up to 1 Year of A

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Stiefel, a GSK Company

Current Primary Outcome: Number of Participants With Overall Cure (OC) [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]

Original Primary Outcome: Negative cultures for the presence of Candida SPP. at post-treatment follow-up visit, study day 14 [ Time Frame: Day 7 and Day 14 ]

Current Secondary Outcome:

• Number of Participants With Clinical Cure [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]
  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.
• Number of Participants With Mycological Cure [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]
  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.
• Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode [ Time Frame: Test-of-cure visit (Day 14) of 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).
• Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode [ Time Frame: Test-of-cure visit (Day 14) of 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).
• Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE) [ Time Frame: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ]
  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.
• Number of Participants With Clinical Cure of First to Third Recurrent Episodes [ Time Frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ]
  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.
• Number of Participants With Mycological Cure of First to Third Recurrent Episodes [ Time Frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ]
  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.

Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: June 18, 2008
Date Started: May 2007
Date Completion:
Last Updated: March 22, 2012
Last Verified: March 2012