NCT00702507

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 15 Months
• Healthy volunteers: Not accepted

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 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.

Conditions

• Diaper Rash

Interventions

Type	Name	Description
DRUG	0.25 % Miconazole Nitrate Ointment	Topical Application

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-06-20
• Last updated: 2012-03-27
• Results posted: 2011-10-07

Locations

8 sites across 4 countries: United States, Dominican Republic, Ecuador, Panama