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

NCT00128323 | Completed Phase 3

• 2 other identifiers: P.01/02/130BSAC Grant GA 532
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Candidiasis, Oral

Keywords

Children; oropharyngeal candidiasis; GV solution; nystatin drops

Outcome Measures

Primary Outcomes (2)

• Clinical clearance of oral candidiasis by day 12

• Fungal clearance of oral candidiasis by saliva culture

Secondary Outcomes (1)

• Clinical and saliva fungal clearance in HIV infected and HIV uninfected children at 12 days and at 21 days

Interventions

Gentian violet 1% solution DRUG

Gentian violet 0.00165% solution DRUG

Nystatin solution DRUG

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kamuzu University of Health Sciences: lead
• British Society for Antimicrobial Chemotherapy: collaborator

Study Sites (1)

Queen Elizabeth Central Hospital, Paediatric Dept, Box 360

Blantyre, 3, Malawi

Location

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

Gentian Violet; Solutions

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Aniline Compounds; Amines; Organic Chemicals; Pharmaceutical Preparations

Study Officials

• ELizabeth M Molyneux, FRCPCH FFAEM

  Malawi College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2005
• First Posted: August 9, 2005
• Study Start: November 1, 2002
• Study Completion: April 1, 2005
• Last Updated: February 11, 2008

Record last verified: 2008-02

Locations

MA (1)