Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128323
Status:
COMPLETED
Last Update Posted:
2008-02-11
First Post:
2005-08-07
Brief Title:
A Comparison of Gentian Violet GV Mouth Washes Nystatin and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis
Sponsor:
Kamuzu University of Health Sciences
Organization:
Kamuzu University of Health Sciences
Study Overview
Official Title:
A Comparison of Gentian Violet Mouth Washes Nystatin Drops and Ketoconazole Tabs in the Treatment of Oropharyngeal Candidiasis
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 000165 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
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 000165 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 groupThis 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
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 groupThis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BSAC Grant GA 532 | None | None | None |