Candidiasis, OralPhase 3NCT00666185
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
A Phase 3 study testing Micafungin and Fluconazole in people with Candidiasis, Oral, run by Astellas Pharma Inc at 37 sites in 3 countries.
Trial summary
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Candidiasis, Oral
- What is being tested?
- Micafungin and Fluconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 523 participants
- Where
- 37 sitesin 3 countries
- Study dates
- Aug 2003to Feb 2004
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of esophageal candidiasis confirmed by endoscopy
- Negative pregnancy test in females of childbearing potential
Who cannot join
- Pregnant or nursing
- Evidence of liver disease
- Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
- Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
- Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
- Non-responsive to therapy in any prior systemic antifungal clinical trail
- History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
- History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
South Africa20 sites
Study site
Arcadia-Pretoria
Study site
Bellville - Cape Town
2 Sites
Bloemfontein
Study site
Brits
Study site
Cape Town
Study site
Centurion
Study site
Dundee
2 Sites
Durban
Study site
Hatfield - Pretoria
Study site
Johannesburg
Study site
Olifantsfontein
Study site
Paarl
2 Sites
Port Elizabeth
Study site
Potchefstroom
3 Sites
Pretoria
Study site
Pretoria West
Study site
Reiger Park
Study site
Richards Bay
Study site
Somerset West
Study site
Westdene - Bloemfontein
Brazil16 sites
Study site
Abadia Uberaba
Study site
Barretos
5 Sites
Belo Horizonte
Study site
Boqueirao - Santos
2 Sites
Campinas
2 Sites
Curitiba
Study site
Goiânia
Study site
Maruipe Victoria
Study site
Nova Iguaçu
Study site
Parquelandia - Fortaleza
Study site
Porto Alegre
Study site
Quinta - Natal
4 Sites
Rio de Janeiro
2 Sites
Salvador
Study site
São José do Rio Preto
8 Sites
São Paulo
About this study
Official title: A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
- Conditions
- Candidiasis, Oral
- Being tested
- Micafungin, Fluconazole
- Keywords
- Micafungin, Esophageal Candidiasis, Fluconazole
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine, FK463
IV
FluconazoleDrug
Also called Diflucan
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Micafungin |
| 2 | Active comparator | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
Measured: End of Therapy
Secondary outcomes (2)
Clinical response at end of therapy of cleared or improved
Measured: End of Therapy
Mucosal response at end of therapy of cleared or improved
Measured: End of Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startAug 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use central contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666185
- Sponsor's protocol ID
- 03-7-005
- Status last verified
- Sep 2014
- First submitted
- 22 Apr 2008
- Last updated
- 18 Sep 2014
- Results posted
- No
Publications
de Wet NT, Bester AJ, Viljoen JJ, Filho F, Suleiman JM, Ticona E, Llanos EA, Fisco C, Lau W, Buell D. A randomized, double blind, comparative trial of micafungin (FK463) vs. fluconazole for the treatment of oesophageal candidiasis. Aliment Pharmacol Ther. 2005 Apr 1;21(7):899-907. doi: 10.1111/j.1365-2036.2005.02427.x.
PubMed 15801925Andes DR, Reynolds DK, Van Wart SA, Lepak AJ, Kovanda LL, Bhavnani SM. Clinical pharmacodynamic index identification for micafungin in esophageal candidiasis: dosing strategy optimization. Antimicrob Agents Chemother. 2013 Nov;57(11):5714-6. doi: 10.1128/AAC.01057-13. Epub 2013 Aug 19.
PubMed 23959319
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
- ClinicalTrials.gov ID
- NCT00666185
- Acronym / sponsor ID
- 03-7-005
- Conditions
- Candidiasis, Oral
- Keywords
- Micafungin, Esophageal Candidiasis, Fluconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 24 Apr 2008 (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.
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Micafungin |
| 2 | Active comparator | Drug: Fluconazole |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of esophageal candidiasis confirmed by endoscopy
- Negative pregnancy test in females of childbearing potential
Key exclusion criteria (8 listed)
- Pregnant or nursing
- Evidence of liver disease
- Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
- Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
- Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
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 |
|---|---|---|
| MicafunginAlso: Mycamine, FK463IV | Drug | 1 |
| FluconazoleAlso: DiflucanIV | Drug | 2 |
Primary outcome
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
Time frame: End of Therapy
2 secondary outcomes
Clinical response at end of therapy of cleared or improved
Time frame: End of Therapy
Mucosal response at end of therapy of cleared or improved
Time frame: End of Therapy
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 18 Sep 2014.
- Background: PubMed 15801925de Wet NT, Bester AJ, Viljoen JJ, Filho F, Suleiman JM, Ticona E, Llanos EA, Fisco C, Lau W, Buell D. A randomized, double blind, comparative trial of micafungin (FK463) vs. fluconazole for the treatment of oesophageal candidiasis. Aliment Pharmacol Ther. 2005 Apr 1;21(7):899-907. doi: 10.1111/j.1365-2036.2005.02427.x.
- Derived from this study: PubMed 23959319Andes DR, Reynolds DK, Van Wart SA, Lepak AJ, Kovanda LL, Bhavnani SM. Clinical pharmacodynamic index identification for micafungin in esophageal candidiasis: dosing strategy optimization. Antimicrob Agents Chemother. 2013 Nov;57(11):5714-6. doi: 10.1128/AAC.01057-13. Epub 2013 Aug 19.
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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.
Use central contact study director
Astellas Pharma US, Inc.
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micafungin and Fluconazole in people with Candidiasis, Oral, run by Astellas Pharma Inc at 37 sites in 3 countries.
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 2 inclusion and 8 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in South Africa, Brazil, Peru. 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?
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy (time frame: End of Therapy). 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 NCT00666185, which also lists 2 linked publications.
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 18 Sep 2014.