Oropharyngeal CandidiasisPhase 4SDVS2WKNCT00553137
Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania
A Phase 4 study testing fluconazole in people with Oropharyngeal Candidiasis, run by Netherlands Organisation for Scientific Research at 1 site in Tanzania.
Trial summary
A prospective randomized double blinded placebo controlled comparative trial will be performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment or not will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Candidiasis
- What is being tested?
- fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTanzania
- Study dates
- Nov 2006to Dec 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection (as determined by positive ELISA and confirmed by Western blot)
- 18 years of age and above
- clinical picture of OPC, characterized by creamy, white, curd like patches, removable by scraping or by typical erythematous lesions (smooth red patches) on the oral mucosa, hard or soft palate and/or dorsal surface of the tongue; and microbiologically by visualization of yeast cells in Potassium hydroxide (10% KOH) preparations prepared from swab of visible lesions and confirmed positive Candida species culture
Who cannot join
- Patients who are currently receiving antifungal therapy or who had received such treatment within three days prior to enrollment in this study
- History of allergy to azole derivatives
- Abnormal liver function tests defined as alanine aminotransferase (ALT), aspartate aminotransferases (AST), or total bilirubin greater than three times the upper limit of normal; or clinical evidence of significant hepatic or renal disease within two months prior to enrollment
- Inability to tolerate oral drug administration; pregnancy or breast feeding; life expectancy of less than four weeks
- Participation in another drug study at the time of enrollment, treatment with drug which interact with fluconazole, such as vitamin K antagonists, warfarin, sulfonylurea anti-diabetic agents, rifampicin, phenytoin, isoniazid, carbamazepine and cisapride
- Documented systemic fungal infections, symptoms suggestive of esophageal candidiasis such as retrosternal chest pain, dysphagia or odynophagia unless this condition has been ruled out by endoscopic examination.
- Patients with history of alcohol abuse, drug addiction and psychiatric disorder, inability to cooperate and poor motivation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences
Dar es Salaam, Dar es Salaam Region, Box 65001
About this study
Official title: Oral Candidiasis in HIV Infected Individuals in Tanzania
A prospective randomized double blinded placebo controlled comparative trial will be performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment or not will be included.
The aim of this study is to compare the efficacy and safety of single dose fluconazole (750mg) and two weeks course of fluconazole (150mg once daily)in the treatment of OPC in HIV positive patients. It is hypothesised that the two regimens are equally effective in the treatment of OPC.
Read the detailed description
A structured standard questionnaire will be used to systematically collect essential data including demography, treatment history and concomitant infections and treatment.
General and oral examination, collection of oral isolates, mycological, hematological and biochemical investigations will be done at baseline and at end of treatment day 13-14.
All Patients will be followed up to 30 days after end of treatment for relapse
- Conditions
- Oropharyngeal Candidiasis
- Being tested
- fluconazole
- Keywords
- oropharyngeal candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluconazoleDrug
750 mg (5 tablets of 150 mg tablets)taken once
fluconazoleDrug
150 mg fluconazole tablets once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days Receives: Drug: fluconazole |
| 2 | Active comparator | 150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once Receives: Drug: fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and mycological cure
Measured: two weeks
Secondary outcomes (1)
recurrence post treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CandidiasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Organisation for Scientific Research
- Sponsor type
- Other government
- Investigators
- Omar JM Hamza, DDS, Principal investigator, Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health SciencesMecky IN Matee, PhD, Study chair, Department of microbiology, Muhimbili University College of Health SciencesFerdinand Mugusi, MD,MMED, Study chair, Department of Internal Medicine, Muhimbili University College of Health SciencesAndre JA Van der Ven, PhD, Study director, Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the NetherlandsPaul E Verweij, PhD, Study chair, Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553137
- Sponsor's protocol ID
- fluc trial tz
- Acronym
- SDVS2WK
- Status last verified
- May 2008
- First submitted
- 2 Nov 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamza OJ, Matee MI, Bruggemann RJ, Moshi MJ, Simon EN, Mugusi F, Mikx FH, van der Lee HA, Verweij PE, van der Ven AJ. Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. Clin Infect Dis. 2008 Nov 15;47(10):1270-6. doi: 10.1086/592578.
PubMed 18840077
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Candidiasis in HIV Infected Individuals in Tanzania
- ClinicalTrials.gov ID
- NCT00553137
- Acronym / sponsor ID
- SDVS2WK / fluc trial tz
- Conditions
- Oropharyngeal Candidiasis
- Keywords
- oropharyngeal candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Netherlands Organisation for Scientific ResearchOther government
- Study start
- Nov 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Nov 2007 (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.
A prospective randomized double blinded placebo controlled comparative trial will be performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment or not will be included.
The aim of this study is to compare the efficacy and safety of single dose fluconazole (750mg) and two weeks course of fluconazole (150mg once daily)in the treatment of OPC in HIV positive patients. It is hypothesised that the two regimens are equally effective in the treatment of OPC.
Detailed description
A structured standard questionnaire will be used to systematically collect essential data including demography, treatment history and concomitant infections and treatment.
General and oral examination, collection of oral isolates, mycological, hematological and biochemical investigations will be done at baseline and at end of treatment day 13-14.
All Patients will be followed up to 30 days after end of treatment for relapse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fluconazolesingle dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days |
| 2 | Active comparator | Drug: fluconazole150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infection (as determined by positive ELISA and confirmed by Western blot)
- 18 years of age and above
- clinical picture of OPC, characterized by creamy, white, curd like patches, removable by scraping or by typical erythematous lesions (smooth red patches) on the oral mucosa, hard or soft palate and/or dorsal surface of the tongue; and microbiologically by visualization of yeast cells in Potassium hydroxide (10% KOH) preparations prepared from swab of visible lesions and confirmed positive Candida species culture
Key exclusion criteria (7 listed)
- Patients who are currently receiving antifungal therapy or who had received such treatment within three days prior to enrollment in this study
- History of allergy to azole derivatives
- Abnormal liver function tests defined as alanine aminotransferase (ALT), aspartate aminotransferases (AST), or total bilirubin greater than three times the upper limit of normal; or clinical evidence of significant hepatic or renal disease within two months prior to enrollment
- Inability to tolerate oral drug administration; pregnancy or breast feeding; life expectancy of less than four weeks
- Participation in another drug study at the time of enrollment, treatment with drug which interact with fluconazole, such as vitamin K antagonists, warfarin, sulfonylurea anti-diabetic agents, rifampicin, phenytoin, isoniazid, carbamazepine and cisapride
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 |
|---|---|---|
| fluconazole750 mg (5 tablets of 150 mg tablets)taken once | Drug | 1 |
| fluconazole150 mg fluconazole tablets once daily for 14 days | Drug | 2 |
Primary outcome
clinical and mycological cure
Time frame: two weeks
1 secondary outcome
recurrence post treatment
Time frame: 4 weeks
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 7 May 2008.
- Derived from this study: PubMed 18840077Hamza OJ, Matee MI, Bruggemann RJ, Moshi MJ, Simon EN, Mugusi F, Mikx FH, van der Lee HA, Verweij PE, van der Ven AJ. Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. Clin Infect Dis. 2008 Nov 15;47(10):1270-6. doi: 10.1086/592578.
Related trials for Oropharyngeal Candidiasis
RecruitingObservational study
Oropharyngeal Candidiasis (OPC) and S-ECC
Candida Infection, Oral Thrush
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.
Omar JM Hamza, DDS principal investigator
Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences
Mecky IN Matee, PhD study chair
Department of microbiology, Muhimbili University College of Health Sciences
Ferdinand Mugusi, MD,MMED study chair
Department of Internal Medicine, Muhimbili University College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluconazole in people with Oropharyngeal Candidiasis, run by Netherlands Organisation for Scientific Research at 1 site in Tanzania.
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 3 inclusion and 7 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 7 May 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 Tanzania. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 and mycological cure (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553137, which also lists 1 linked publication.
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 7 May 2008.