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Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
This study has been completed.
Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00702507
First received: June 18, 2008
Last updated: March 22, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Diaper Rash | Drug: 0.25 % Miconazole Nitrate Ointment | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 Age With Recurrent Moderate-Severe Diaper Dermatitis Complicated by Cutaneous Candidiasis |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
Primary Outcome Measures:
- Number of Participants With Overall Cure (OC) [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ]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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 200 |
| Study Start Date: | May 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Miconazole Nitrate |
Drug: 0.25 % Miconazole Nitrate Ointment
Topical Application
Other Name: Vusion
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 15 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female neonate or infant up to 1 year of age with Fitzpatrick Skin Type I-VI
- Clinical evidence of diaper dermatitis and a positive KOH result for pseudohyphae and/or budding yeast at baseline visit
- Overall Diaper Dermatitis Severity Index score at baseline visit of 4-8 (must include an overall clinical grade of at least 2 for erythema)
- Wear commercially available diapers day and night for at least 7 days prior to enrollment and during the course of the 2 year study
- Caretaker must complete informed consent process
Exclusion Criteria:
- Known sensitivity to any component of the formulation
- No other skin conditions that may confound the evaluation of the drug efficacy or tolerability
- Known sensitivity to skin care toiletry products or diapers
- History of HIV positive
- Chronic illnesses that require systemic medication that may confound the evaluation of study drug efficacy or tolerability (antibiotic therapy is not included)
- Treatment with a prescription product for diaper dermatitis or other skin condition 7 days prior to enrollment
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702507
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702507
Locations
| United States, California | |
| Sheila Fallon Friedlander, MD | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| David Rodriguez, MD | |
| Coral Gables, Florida, United States, 33134 | |
| Lawrence Schachner, MD | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Wilson P. Andrews Jr., MD | |
| Marietta, Georgia, United States, 30062 | |
| United States, Texas | |
| Lewis Purnell, MD | |
| San Antonio, Texas, United States, 78229 | |
| Dominican Republic | |
| Daisy Blanco, MD | |
| Santo Domingo, Dominican Republic | |
| Ecuador | |
| Manuel Briones, MD | |
| Guayaquil, Ecuador | |
| Panama | |
| Zila Espinosa, MD | |
| Panama City, Panama | |
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stiefel, a GSK Company |
| ClinicalTrials.gov Identifier: | NCT00702507 History of Changes |
| Other Study ID Numbers: |
114678 BT0100-402-USA ( Other Identifier: Barrier Therapeutics ) |
| Study First Received: | June 18, 2008 |
| Results First Received: | September 1, 2011 |
| Last Updated: | March 22, 2012 |
Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
|
Diaper dermatitis complicated by candidiasis |
Additional relevant MeSH terms:
|
Diaper Rash Dermatitis, Irritant Dermatitis, Contact Dermatitis Skin Diseases Skin Diseases, Eczematous Miconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors |
Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP3A Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017