MycosesPhase 3NCT00001940
Voriconazole to Treat Fungal Infections
A Phase 3 study testing Voriconazole in people with Mycoses, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycoses
- What is being tested?
- Voriconazole
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jul 2001
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Males or (non-pregnant, lactating and nursing) females equal to or greater than 12 years of age.
Previous enrollment into and completion of voriconazole therapy in protocol 99-C-0094 investigating the use of voriconazole in the treatment of invasive fungal disease or empirical treatment of presumed fungal infections and enrolled within three weeks of completion of 99-C-0094B.
Clinical benefit was derived from previous voriconazole treatment.
Further clinical benefit is expected with extended voriconazole treatment.
Women of child bearing potential (or less than 2 years post- menopausal) must have a negative serum pregnancy test at baseline, and must agree to use barrier methods of contraception during the study.
Signed written informed consent must be obtained at protocol entry.
Assent will be obtained from minors capable of understanding.
Subjects must not have either ongoing serious adverse events probably related to voriconazole therapy or have ongoing adverse events probably related to voriconazole therapy which may pose a significant risk on continued therapy.
Must not have previously participated in this trial.
If receiving, must be able to discontinue the following drugs at least 24 hours prior to randomization: terfenadine, cisapride, and astemizole.
If receiving, must be able to discontinue sulphonylureas at least 24 hours prior to randomization.
Must not have received the following drugs within 14 days prior to randomization: rifampin, carbamazepine, or barbiturates.
Must not have AST, ALT, greater than 10 (upper limit normal).
Must not have serum creatinine greater than 3.0 mg/dl.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections
Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients.
Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop.
Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.
Read the detailed description
The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy or that are unresponsive or intolerant to treatment with approved systemic antifungal agents. This trial is an extension of the Phase III multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 100 patients to be recruited from multiple centers. The patient population will consist of patients with proven deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents and currently on the voriconazole (99-C-0094) protocol. Voriconazole will be administered intravenously at 3-4 mg/kg q 12 hours or orally at 200-300 mg BID. Efficacy will be evaluated by clinical, radiological and microbiological response.
- Conditions
- Mycoses
- Being tested
- Voriconazole
- Keywords
- Antifungal Agent, Aspergillosis, Candidemia, Fungemia
- Medical subject headings
- Mycoses, Aspergillosis, Candidemia, Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 1999
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MycosesStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 3
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001940
- Sponsor's protocol ID
- 000024
- Other IDs
- 00-C-0024
- Status last verified
- Nov 2000
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT00001940
- Acronym / sponsor ID
- 000024
- Conditions
- Mycoses
- Keywords
- Antifungal Agent, Aspergillosis, Candidemia, Fungemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 1999
- Study completion
- Jul 2001
- First posted
- 10 Dec 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.
Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients.
Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop.
Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.
Detailed description
The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy or that are unresponsive or intolerant to treatment with approved systemic antifungal agents. This trial is an extension of the Phase III multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 100 patients to be recruited from multiple centers. The patient population will consist of patients with proven deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents and currently on the voriconazole (99-C-0094) protocol. Voriconazole will be administered intravenously at 3-4 mg/kg q 12 hours or orally at 200-300 mg BID. Efficacy will be evaluated by clinical, radiological and microbiological response.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Voriconazole | 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 4 Mar 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 3 study testing Voriconazole in people with Mycoses, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 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 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.
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 4 Mar 2008.