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

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ClinicalTrials.gov Identifier: NCT00128323
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : February 11, 2008
Sponsor:
Collaborator:
British Society for Antimicrobial Chemotherapy
Information provided by:
University of Malawi College of Medicine

Tracking Information
First Submitted Date  ICMJE August 7, 2005
First Posted Date  ICMJE August 9, 2005
Last Update Posted Date February 11, 2008
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2005)
  • Clinical clearance of oral candidiasis by day 12
  • Fungal clearance of oral candidiasis by saliva culture
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2005)
Clinical and saliva fungal clearance in HIV infected and HIV uninfected children at 12 days and at 21 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis
Official Title  ICMJE A Comparison of Gentian Violet Mouth Washes, Nystatin Drops and Ketoconazole Tabs in the Treatment of Oropharyngeal Candidiasis
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Candidiasis, Oral
Intervention  ICMJE
  • Drug: Gentian violet 1% solution
  • Drug: Gentian violet 0.00165% solution
  • Drug: Nystatin solution
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 7, 2005)
558
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128323
Other Study ID Numbers  ICMJE P.01/02/130
BSAC Grant GA 532
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Malawi College of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE British Society for Antimicrobial Chemotherapy
Investigators  ICMJE
Principal Investigator: ELizabeth M Molyneux, FRCPCH FFAEM Malawi College of Medicine
PRS Account University of Malawi College of Medicine
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP