Overview

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis

Status:
Completed

Trial end date:
2005-04-01

Target enrollment:
0

Participant gender:
All

Summary

In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Malawi College of Medicine

Collaborator:

British Society for Antimicrobial Chemotherapy

Treatments:

Gentian Violet
Ketoconazole
Nystatin
Pharmaceutical Solutions

Criteria

Inclusion Criteria:

- All children up to 14 years of age with proven oral candidiasis

Exclusion Criteria:

- Children already on an antifungal agent or who had received an antifungal agent in the
last week.