Candidiasis, OralPhase 3NCT00128323
A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis
A Phase 3 study testing Gentian violet 1% solution, Gentian violet 0.00165% solution and Nystatin solution in people with Candidiasis, Oral, run by Kamuzu University of Health Sciences at 1 site in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Candidiasis, Oral
- What is being tested?
- Gentian violet 1% solution, Gentian violet 0.00165% solution and Nystatin solution
- How many people
- 558 participants
- Where
- 1 siteMalawi
- Study dates
- Nov 2002to Apr 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children up to 14 years of age with proven oral candidiasis
Who cannot join
- Children already on an antifungal agent or who had received an antifungal agent in the last week.
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Queen Elizabeth Central Hospital, Paediatric Dept, Box 360
Blantyre, 3
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Candidiasis, Oral
- Being tested
- Gentian violet 1% solution, Gentian violet 0.00165% solution, Nystatin solution
- Keywords
- Children, oropharyngeal candidiasis, GV solution, nystatin drops
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentian violet 1% solutionDrug
Gentian violet 0.00165% solutionDrug
Nystatin solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical clearance of oral candidiasis by day 12
Fungal clearance of oral candidiasis by saliva culture
Secondary outcomes (1)
Clinical and saliva fungal clearance in HIV infected and HIV uninfected children at 12 days and at 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startNov 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 558 participants
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- British Society for Antimicrobial Chemotherapy
- Investigators
- ELizabeth M Molyneux, FRCPCH FFAEM, Principal investigator, Malawi College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128323
- Sponsor's protocol ID
- P.01/02/130
- Other IDs
- BSAC Grant GA 532
- Status last verified
- Feb 2008
- First submitted
- 7 Aug 2005
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Gentian Violet Mouth Washes, Nystatin Drops and Ketoconazole Tabs in the Treatment of Oropharyngeal Candidiasis
- ClinicalTrials.gov ID
- NCT00128323
- Acronym / sponsor ID
- P.01/02/130
- Conditions
- Candidiasis, Oral
- Keywords
- Children, oropharyngeal candidiasis, GV solution, nystatin drops
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Collaborators
- British Society for Antimicrobial Chemotherapy
- Study start
- Nov 2002
- Study completion
- Apr 2005 (actual)
- First posted
- 9 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children up to 14 years of age with proven oral candidiasis
Key exclusion criteria (1 listed)
- Children already on an antifungal agent or who had received an antifungal agent in the last week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentian violet 1% solution | Drug | – |
| Gentian violet 0.00165% solution | Drug | – |
| Nystatin solution | Drug | – |
Primary outcome
Clinical clearance of oral candidiasis by day 12
Fungal clearance of oral candidiasis by saliva culture
1 secondary outcome
Clinical and saliva fungal clearance in HIV infected and HIV uninfected children at 12 days and at 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ELizabeth M Molyneux, FRCPCH FFAEM principal investigator
Malawi College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gentian violet 1% solution, Gentian violet 0.00165% solution and Nystatin solution in people with Candidiasis, Oral, run by Kamuzu University of Health Sciences at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical clearance of oral candidiasis by day 12. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2008.