AspergillosisPhase 3NCT00001937
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
A Phase 3 study testing FK463 and Fluconazole in people with Aspergillosis and Candidiasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Fever and infection are serious complications of cancer treatment such as bone marrow transplant, especially when white blood cell counts are low. When the number of white blood cells is below 500, the person has a condition called neutropenia and has a high risk of developing an infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aspergillosis, Candidiasis, Fungemia
- What is being tested?
- FK463 and Fluconazole
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Dec 2000
- 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
Informed consent of the patient or legally authorized representative must be obtained prior to entry.
Verbal assent will be obtained from minors capable of understanding.
Patients may be of either gender. Females of childbearing potential must have a negative pregnancy test obtained within 14 days prior to the first dose of study drug.
Patients greater than or equal to 6 months of age.
Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant;
Any patient undergoing an allogeneic hematopoietic stem cell transplant.
Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables.
No patients who are pregnant or nursing. Females of childbearing potential must avoid becoming pregnant by abstinence or barrier methods of birth control while receiving antifungal agents.
No patients with moderate or severe liver disease, as defined by:
AST or ALT greater than 5 times upper limit of normal (ULN), OR;
Total bilirubin greater than 2.5 times ULN.
No patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment.
No patients who have received systemic antifungal agents within 72 hours prior to the first dose of study drug.
No patients receiving an autologous transplant for nonhematologic malignancies.
No patients known to be infected with HIV due to the lack of data on drug interaction between highly active antiretroviral therapy (HAART) and FK463.
No patients previously randomized in this study.
No patients with a history of anaphylaxis attributed to azole compounds or the echinocandin class or antifungals.
No patients with a concomitant medical condition, in the opinion of the investigator and/or medical monitor, whose participation may create an unacceptable additional risk for the patient.
No patients receiving another investigational drug other than for the treatment of cancer or supportive care.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant
Fever and infection are serious complications of cancer treatment such as bone marrow transplant, especially when white blood cell counts are low. When the number of white blood cells is below 500, the person has a condition called neutropenia and has a high risk of developing an infection. At the first sign of fever, antibiotics are started. However, antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus, the prevention of fungal infections in this population is important. The only medicine approved for prevention of fungal infections is fluconazole, which prevents some but not all types of such infections. A new antifungal medication called FK463 works against more types of fungal infections than fluconazole does. This study will compare the effectiveness, safety, and tolerance of FK463 as compared with fluconazole.
Eight hundred patients will be enrolled in this study. They will be randomly assigned to receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well as a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole or FK463 will be administered once a day for one hour into the bloodstream through a catheter in the vein. Blood tests will be taken twice a week. Cultures from the blood, mouth, and urine will be taken throughout the study. X-rays and CT scans will only be taken if a fungal infection is suspected. If fever develops, blood will be drawn to check for fungi. If fever and neutropenia continue for more than 4 days, FK463 or fluconazole will be stopped and a standard medication called amphotericin B will be started.
Both FK463 and fluconazole will be administered until white blood cell count returns to greater than 500 (signifying recovery from neutropenia), or up to 42 days after transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.
Read the detailed description
The objective of this study is to determine the efficacy and safety of FK463 versus fluconazole in preventing fungal infections in patients undergoing an autologous (for hematologic malignancies) or allogeneic hematopoietic stem cell transplant. This is a Phase III, multicenter, randomized, double-blind study in patients six months of age and older. Study drug, either FK463 at 50 mg/day (1.0 mg/kg/day in patients weighing less than 50 kg) or fluconazole at 400 mg/day (8 mg/kg/day in patients weighing less than 50 kg), will be administered intravenously once daily in a blinded manner. Study drug will continue until neutrophil recovery (defined as a post nadir absolute neutrophil count (ANC) of greater than or equal to 500/mm3). Patients who develop a proven, probable, or suspected (requires empirical antifungal therapy) fungal infection will be discontinued from the prophylactic regimen. The maximum time the patient may receive study drug is 42 days post transplant.
- Conditions
- Aspergillosis, Candidiasis, Fungemia, Mycoses
- Being tested
- FK463, Fluconazole
- Keywords
- Aspergillosis, Candidiasis, Fungal Infections, Fungemia, Prophylactic Antifungal Therapy
- Medical subject headings
- Aspergillosis, Candidiasis, Fungemia, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK463Drug
FluconazoleDrug
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 startNov 1999
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AspergillosisStudies 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
- 800 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001937
- Sponsor's protocol ID
- 000014
- Other IDs
- 00-C-0014
- Status last verified
- Nov 1999
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
PubMed 1542320Slavin MA, Osborne B, Adams R, Levenstein MJ, Schoch HG, Feldman AR, Meyers JD, Bowden RA. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation--a prospective, randomized, double-blind study. J Infect Dis. 1995 Jun;171(6):1545-52. doi: 10.1093/infdis/171.6.1545.
PubMed 7769290Pannuti C, Gingrich R, Pfaller MA, Kao C, Wenzel RP. Nosocomial pneumonia in patients having bone marrow transplant. Attributable mortality and risk factors. Cancer. 1992 Jun 1;69(11):2653-62. doi: 10.1002/1097-0142(19920601)69:113.0.co;2-8.
PubMed 1315207
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
- A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00001937
- Acronym / sponsor ID
- 000014
- Conditions
- Aspergillosis, Candidiasis, Fungemia, Mycoses
- Keywords
- Aspergillosis, Candidiasis, Fungal Infections, Fungemia, Prophylactic Antifungal Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 1999
- Study completion
- Dec 2000
- 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.
Fever and infection are serious complications of cancer treatment such as bone marrow transplant, especially when white blood cell counts are low. When the number of white blood cells is below 500, the person has a condition called neutropenia and has a high risk of developing an infection. At the first sign of fever, antibiotics are started. However, antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus, the prevention of fungal infections in this population is important. The only medicine approved for prevention of fungal infections is fluconazole, which prevents some but not all types of such infections. A new antifungal medication called FK463 works against more types of fungal infections than fluconazole does. This study will compare the effectiveness, safety, and tolerance of FK463 as compared with fluconazole.
Eight hundred patients will be enrolled in this study. They will be randomly assigned to receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well as a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole or FK463 will be administered once a day for one hour into the bloodstream through a catheter in the vein. Blood tests will be taken twice a week. Cultures from the blood, mouth, and urine will be taken throughout the study. X-rays and CT scans will only be taken if a fungal infection is suspected. If fever develops, blood will be drawn to check for fungi. If fever and neutropenia continue for more than 4 days, FK463 or fluconazole will be stopped and a standard medication called amphotericin B will be started.
Both FK463 and fluconazole will be administered until white blood cell count returns to greater than 500 (signifying recovery from neutropenia), or up to 42 days after transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.
Detailed description
The objective of this study is to determine the efficacy and safety of FK463 versus fluconazole in preventing fungal infections in patients undergoing an autologous (for hematologic malignancies) or allogeneic hematopoietic stem cell transplant. This is a Phase III, multicenter, randomized, double-blind study in patients six months of age and older. Study drug, either FK463 at 50 mg/day (1.0 mg/kg/day in patients weighing less than 50 kg) or fluconazole at 400 mg/day (8 mg/kg/day in patients weighing less than 50 kg), will be administered intravenously once daily in a blinded manner. Study drug will continue until neutrophil recovery (defined as a post nadir absolute neutrophil count (ANC) of greater than or equal to 500/mm3). Patients who develop a proven, probable, or suspected (requires empirical antifungal therapy) fungal infection will be discontinued from the prophylactic regimen. The maximum time the patient may receive study drug is 42 days post transplant.
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 |
|---|---|---|
| FK463 | Drug | – |
| Fluconazole | 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.
- Background: PubMed 1542320Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
- Background: PubMed 7769290Slavin MA, Osborne B, Adams R, Levenstein MJ, Schoch HG, Feldman AR, Meyers JD, Bowden RA. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation--a prospective, randomized, double-blind study. J Infect Dis. 1995 Jun;171(6):1545-52. doi: 10.1093/infdis/171.6.1545.
- Background: PubMed 1315207Pannuti C, Gingrich R, Pfaller MA, Kao C, Wenzel RP. Nosocomial pneumonia in patients having bone marrow transplant. Attributable mortality and risk factors. Cancer. 1992 Jun 1;69(11):2653-62. doi: 10.1002/1097-0142(19920601)69:113.0.co;2-8.
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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 FK463 and Fluconazole in people with Aspergillosis and Candidiasis, 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?
On the ClinicalTrials.gov record for NCT00001937, which also lists 3 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 4 Mar 2008.