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

This study has been completed.
Sponsor:
Collaborator:
British Society for Antimicrobial Chemotherapy
Information provided by:
University of Malawi College of Medicine
ClinicalTrials.gov Identifier:
NCT00128323
First received: August 7, 2005
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Candidiasis, Oral
Drug: Gentian violet 1% solution
Drug: Gentian violet 0.00165% solution
Drug: Nystatin solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Gentian Violet Mouth Washes, Nystatin Drops and Ketoconazole Tabs in the Treatment of Oropharyngeal Candidiasis

Resource links provided by NLM:


Further study details as provided by University of Malawi College of Medicine:

Primary Outcome Measures:
  • Clinical clearance of oral candidiasis by day 12
  • Fungal clearance of oral candidiasis by saliva culture

Secondary Outcome Measures:
  • Clinical and saliva fungal clearance in HIV infected and HIV uninfected children at 12 days and at 21 days

Estimated Enrollment: 558
Study Start Date: November 2002
Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128323

Locations
Malawi
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Blantyre, Malawi, 3
Sponsors and Collaborators
University of Malawi College of Medicine
British Society for Antimicrobial Chemotherapy
Investigators
Principal Investigator: ELizabeth M Molyneux, FRCPCH FFAEM Malawi College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00128323     History of Changes
Other Study ID Numbers: P.01/02/130, BSAC Grant GA 532
Study First Received: August 7, 2005
Last Updated: February 7, 2008
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Malawi College of Medicine:
Children
oropharyngeal candidiasis
GV solution
nystatin drops

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Mycoses
Mouth Diseases
Stomatognathic Diseases
Gentian Violet
Ketoconazole
Nystatin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Ionophores
Membrane Transport Modulators
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 08, 2014