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

February 7, 2008 updated by: Kamuzu University of Health Sciences

A Comparison of Gentian Violet Mouth Washes, Nystatin Drops and Ketoconazole Tabs in the Treatment of Oropharyngeal Candidiasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A double blind randomised trial of 2 strengths of GV solution and nystatin oral drops in the treatment of oropharyngeal candidiasis in children.

Children with oral thrush were enrolled from the paediatric wards of the Queen Elizabeth Central Hospital after permission and full information was given to the guardians.

Children of any age up to 14 years were included.

Mothers or guardians gave permission after pre counselling for HIV testing, and a saliva sample collection on enrollment. A full history and examination was carried out. The extent and severity of the candidal infection recorded on oral pictorial graphs and graded.

The child was then prescribed a treatment of A, B or C solution which was introduced into the mouth with a pipette. One ml of the solution was prescribed 3 times a day for 10 days.

The children were reviewed on day 3 to ensure no worsening of the condition and on day 12 when another saliva sample was taken.

A further review was carried out on day 21 of a limited number of children to repeat the saliva test.

Exclusions to the study were children who were already on an antifungal agent or those who had evidence of infection beyond the pharynx into the peritonsillar bed, suggesting the presence of oesophageal infection. These children were prescribed ketoconazole tabs.

If the oral infection was worse on day 3 miconazole gel was prescribed and the study medication stopped.

Sample size to achieve 80% power to detect a difference in failure rates of 20% and 10% (20% in the nystatin group and 10% in the GV groups) is 155 in each group.This assumes an HIV positivity of 50%. As a drop out rate of 20% is expected from death (in some HIV infected patients) or failure to attend for follow up, a sample size of 186 per group is to be recruited. This gives an overall number to be enrolled of 558 patients.

Recruitment has been completed - analysis is in progress.

Study Type

Interventional

Enrollment

558

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi, 3
        • Queen Elizabeth Central Hospital, Paediatric Dept, Box 360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical clearance of oral candidiasis by day 12
Fungal clearance of oral candidiasis by saliva culture

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamuzu University of Health Sciences

Collaborators

British Society for Antimicrobial Chemotherapy

Investigators

  • Principal Investigator: ELizabeth M Molyneux, FRCPCH FFAEM, Malawi College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

August 7, 2005

First Submitted That Met QC Criteria

August 7, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

February 11, 2008

Last Update Submitted That Met QC Criteria

February 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.01/02/130
  • BSAC Grant GA 532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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