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

NCT00128323 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2008-02-11

No results posted yet for this study

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

Interventions

DRUG

Gentian violet 1% solution

DRUG

Gentian violet 0.00165% solution

DRUG

Nystatin solution

Sponsors & Collaborators

  • British Society for Antimicrobial Chemotherapy

    collaborator OTHER

  • Kamuzu University of Health Sciences

    lead OTHER

Principal Investigators

  • ELizabeth M Molyneux, FRCPCH FFAEM · Malawi College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Completion
2005-04-30

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00128323 on ClinicalTrials.gov