CandidiasisPhase 2NCT00037219
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
A Phase 2 study testing Anidulafungin, VER002 in people with Candidiasis, run by Pfizer at 1 site in United States.
Trial summary
Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis
- What is being tested?
- Anidulafungin, VER002
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Nov 2002
- Phase
- Phase 2
- 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
- Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
- Life expectancy: greater than 72 hours
Who cannot join
- Pregnant Females
- Treatment with other investigational drug(s) within 4 weeks
- Hypersensitivity to anidulafungin or echinocandin therapy
- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis
Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.
- Conditions
- Candidiasis
- Being tested
- Anidulafungin, VER002
- Keywords
- Anidulafungin, Candidemia, Invasive Candidiasis
- Medical subject headings
- Candidiasis, Candidemia, Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anidulafungin, VER002Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startAug 2001
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vicuron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037219
- Sponsor's protocol ID
- VER002-6
- Other IDs
- A8851018
- Status last verified
- Oct 2008
- First submitted
- 16 May 2002
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT00037219
- Acronym / sponsor ID
- VER002-6
- Conditions
- Candidiasis
- Keywords
- Anidulafungin, Candidemia, Invasive Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Vicuron Pharmaceuticals
- Study start
- Aug 2001
- Study completion
- Nov 2002 (actual)
- First posted
- 17 May 2002 (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.
Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
- Life expectancy: greater than 72 hours
Key exclusion criteria (4 listed)
- Pregnant Females
- Treatment with other investigational drug(s) within 4 weeks
- Hypersensitivity to anidulafungin or echinocandin therapy
- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
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 |
|---|---|---|
| Anidulafungin, VER002 | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anidulafungin, VER002 in people with Candidiasis, run by Pfizer at 1 site in United States.
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 4 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 21 Oct 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 21 Oct 2008.