CandidaPhase 3NCT00058682
Anidulafungin Versus Fluconazole in the Treatment of Candidemia
A Phase 3 study testing Anidulafungin in people with Candida and Candidiasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to candida. The experimental drug anidulafungin has been found to be active in treating life-threatening fungal infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candida, Candidiasis
- What is being tested?
- Anidulafungin
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2005
- 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
Who may be able to join
- Diagnosis of candidemia or other forms of invasive candidiasis from a blood culture or a culture specimen from a normally sterile site, the sample preferably having been taken within 96 hours before study entry. The diagnosis will be based on the following:
- Candidemia: at least one blood culture positive for yeast (in the absence of other demonstrated foci of infection).
- Other Forms of Invasive Candidiasis:
- Positive culture for yeast from a specimen from a normally sterile site with or without a positive blood culture;
- Positive yeast culture from a newly-placed drain in a normally sterile site; or
- Any positive blood culture for yeast plus ophthalmic examination consistent with Candida endophthalmitis (patients with mycological documentation of Candida endophthalmitis with negative blood cultures will be included).
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- Positive yeast cultures from urine or sputum do NOT qualify as a positive culture.
- AND at least one of the following signs and symptoms:
- A fever defined as an oral temperature of 100.4° (Degree) F (38.0° (Degree)C) or greater, rectal temperature of 101.4° (Degree) F (38.4° (Degree)C) or greater, or an axillary temperature of 99.4° (Degree) F (37° (Degree)C) or greater. Hypothermia defined as a temperature less than 96.8° (Degree) F (36.0° (Degree)C).
- A systolic blood pressure of less than 100 mmHg or a decrease in systolic blood pressure of at least 30 mmHg from patient's normal systolic blood pressure.
- Some sign of inflammation (swelling, heat, erythema, purulence, or drainage from a wound) at a site positive for Candida
- Signs or symptoms of candidemia/invasive candidiasis.
- Radiological findings of invasive candidiasis.
- Male or female 16 years of age or older.
- Willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children less than 18 years of age.
- Reliable and willing to make themselves available for the duration of the study and to abide by the study restrictions.
- Expected hospitalization of at least 3 days.
Who cannot join
- Female patients who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of child bearing potential and not using an acceptable method of birth control (i.e. abstinence, surgically sterile, intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam). Patients are to continue contraceptive methods during the study and for at least 30 days after receiving their last treatment.
- Patients who have received greater than 72 hours of systemic antifungal therapy for the Candida infection for which they will be enrolled (patients who develop their Candida infection while receiving caspofungin or azole therapy will also be excluded).
- Patients who have received prophylactic administration of fluconazole, itraconzaole, or voriconazole greater than or equal to one week within 30 days prior to enrollment.
- Patients who have failed antifungal therapy with any systemic antifungal for this episode of candidiasis/candidemia. Recurrence within 2 weeks is considered failure of previous therapy.
- Patients with suspected Candida osteomyelitis, endocarditis, or meningitis.
- Patients with prosthetic devices which are a suspected site of infection are excluded unless the device is removed at study entry or soon after randomization. [Hemodialysis shunts (AV fistulae) may reamin in situ].
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- Patients with prosthetic heart valves or vascular grafts suspected to be the site of the candida infection and positive blood cultures.
- Patients receiving and who will continue to receive terfenadine, cisapride, dofetilide, quinidine, pimozide and rifampin.
- Patients who have, at any time, previously received anidulafungin.
- Known Candida krusei infection.
- Patients requiring continued treatment with another systemic antifungal agent [oral non-absorbable azoles (e.g., clotrimazole troches) are permitted].
- Patients with a known hypersensitivity to echinocandin therapy or azole therapy.
- Patients with any of the following abnormal laboratory values:
- bilirubin greater than 5 times theULN
- AST or ALT greater than 5 times theULN
- Patients with poor venous access that would preclude intravenous drug delivery or multiple blood draws.
- Patients who have participated in a study of an investigational drug or device (without any FDA approved indications) within four weeks of study entry. The investigational use of antiretroviral agents and the investigational use of licensed agents is permitted if the patient is on a stable regimen for four weeks prior to study start.
- Life expectancy less than 72 hours.
- Patients on hemodialysis unable to tolerate the volume of IV fluid on non-dialysis days.
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, Double Blind, Randomized, Multi-Center Study of the Safety and Efficacy of Anidulafungin VS. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications
Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to candida. The experimental drug anidulafungin has been found to be active in treating life-threatening fungal infections. The purpose of this study is to determine whether anidulafungin is as effective as fluconazole in treating candidemia, an invasive form of candidiasis.
Three hundred patients 16 years of age or older will participate in this study. Participants will be randomly assigned to one of two groups: one-half will receive anidulafungin; the other half will receive fluconazole. They will receive the drug for as few as 10 days or for up to 42 days, depending on the seriousness of the infection. The drug will be given over a four-hour period on the first day, and over two hours on the remaining days. While taking the study medication, participants will be required to give blood samples every week until the end of treatment. At two weeks and six weeks following the end of therapy, participants will return for evaluation.
Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, an eye exam, an electrocardiogram, and possibly blood work.
Read the detailed description
This study is designed as a prospective, randomized, double-blind, non-inferiority, multi-center trial of the safety and efficacy of anidulafungin versus fluconazole in patients with candidemia or other forms of invasive candidiasis. The objective of this study is to determine if anidulafungin is at least as effective as fluconazole in the treatment of patients with a diagnosis of candidemia and/or other forms of invasive candidiasis. The secondary objectives are to compare the safety of the two study drugs and determine the efficacy for the prevention of late Candida infections in patients treated with anidulafungin versus fluconazole. Assuming 25% of patients will be unevaluable at the end of intravenous therapy, 248 patients will be enrolled to obtain a total of 222 evaluable patients. Patients older than 16 years of age with candidemia or invasive candidiasis will be randomized to receive either anidulafungin or fluconazole. Patients randomized to anidulafungin will receive an IV loading dose on day one of 200mg followed by 100mg once daily. Patients randomized to fluconazole will receive an IV loading dose on day one of 800mg followed by an IV daily dose of 400mg. Patients will be maintained on IV therapy for a minimum of 10 days to a maximum of 42 days. After 10 days of therapy, patients on either study drug may be treated on an ambulatory basis with oral fluconazole therapy.
- Conditions
- Candida, Candidiasis
- Being tested
- Anidulafungin
- Keywords
- Fungal Infection, Mycoses, Candida Species, Candidiasis
- Medical subject headings
- Torulopsis, Candidiasis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnidulafunginDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2003 (estimated)
- Study startApr 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CandidaStudies 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
- 248 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058682
- Sponsor's protocol ID
- 030150
- Other IDs
- 03-C-0150
- Status last verified
- Jan 2005
- First submitted
- 11 Apr 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Wey SB, Mori M, Pfaller MA, Woolson RF, Wenzel RP. Hospital-acquired candidemia. The attributable mortality and excess length of stay. Arch Intern Med. 1988 Dec;148(12):2642-5. doi: 10.1001/archinte.148.12.2642.
PubMed 3196127Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. doi: 10.1093/clinids/20.6.1526.
PubMed 7548503Pfaller MA. Epidemiology and control of fungal infections. Clin Infect Dis. 1994 Aug;19 Suppl 1:S8-13. doi: 10.1093/clinids/19.supplement_1.s8.
PubMed 7948573Kett DH, Shorr AF, Reboli AC, Reisman AL, Biswas P, Schlamm HT. Anidulafungin compared with fluconazole in severely ill patients with candidemia and other forms of invasive candidiasis: support for the 2009 IDSA treatment guidelines for candidiasis. Crit Care. 2011;15(5):R253. doi: 10.1186/cc10514. Epub 2011 Oct 25.
PubMed 22026929Reboli AC, Shorr AF, Rotstein C, Pappas PG, Kett DH, Schlamm HT, Reisman AL, Biswas P, Walsh TJ. Anidulafungin compared with fluconazole for treatment of candidemia and other forms of invasive candidiasis caused by Candida albicans: a multivariate analysis of factors associated with improved outcome. BMC Infect Dis. 2011 Sep 30;11:261. doi: 10.1186/1471-2334-11-261.
PubMed 21961941
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, Double Blind, Randomized, Multi-Center Study of the Safety and Efficacy of Anidulafungin VS. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications
- ClinicalTrials.gov ID
- NCT00058682
- Acronym / sponsor ID
- 030150
- Conditions
- Candida, Candidiasis
- Keywords
- Fungal Infection, Mycoses, Candida Species, Candidiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2003
- Study completion
- Jan 2005
- First posted
- 11 Apr 2003 (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.
Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to candida. The experimental drug anidulafungin has been found to be active in treating life-threatening fungal infections. The purpose of this study is to determine whether anidulafungin is as effective as fluconazole in treating candidemia, an invasive form of candidiasis.
Three hundred patients 16 years of age or older will participate in this study. Participants will be randomly assigned to one of two groups: one-half will receive anidulafungin; the other half will receive fluconazole. They will receive the drug for as few as 10 days or for up to 42 days, depending on the seriousness of the infection. The drug will be given over a four-hour period on the first day, and over two hours on the remaining days. While taking the study medication, participants will be required to give blood samples every week until the end of treatment. At two weeks and six weeks following the end of therapy, participants will return for evaluation.
Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, an eye exam, an electrocardiogram, and possibly blood work.
Detailed description
This study is designed as a prospective, randomized, double-blind, non-inferiority, multi-center trial of the safety and efficacy of anidulafungin versus fluconazole in patients with candidemia or other forms of invasive candidiasis. The objective of this study is to determine if anidulafungin is at least as effective as fluconazole in the treatment of patients with a diagnosis of candidemia and/or other forms of invasive candidiasis. The secondary objectives are to compare the safety of the two study drugs and determine the efficacy for the prevention of late Candida infections in patients treated with anidulafungin versus fluconazole. Assuming 25% of patients will be unevaluable at the end of intravenous therapy, 248 patients will be enrolled to obtain a total of 222 evaluable patients. Patients older than 16 years of age with candidemia or invasive candidiasis will be randomized to receive either anidulafungin or fluconazole. Patients randomized to anidulafungin will receive an IV loading dose on day one of 200mg followed by 100mg once daily. Patients randomized to fluconazole will receive an IV loading dose on day one of 800mg followed by an IV daily dose of 400mg. Patients will be maintained on IV therapy for a minimum of 10 days to a maximum of 42 days. After 10 days of therapy, patients on either study drug may be treated on an ambulatory basis with oral fluconazole therapy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of candidemia or other forms of invasive candidiasis from a blood culture or a culture specimen from a normally sterile site, the sample preferably having been taken within 96 hours before study entry. The diagnosis will be based on the following:
- Candidemia: at least one blood culture positive for yeast (in the absence of other demonstrated foci of infection).
- Other Forms of Invasive Candidiasis:
- AND at least one of the following signs and symptoms:
- Radiological findings of invasive candidiasis.
Key exclusion criteria (19 listed)
- Female patients who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of child bearing potential and not using an acceptable method of birth control (i.e. abstinence, surgically sterile, intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam). Patients are to continue contraceptive methods during the study and for at least 30 days after receiving their last treatment.
- Patients who have received greater than 72 hours of systemic antifungal therapy for the Candida infection for which they will be enrolled (patients who develop their Candida infection while receiving caspofungin or azole therapy will also be excluded).
- Patients who have received prophylactic administration of fluconazole, itraconzaole, or voriconazole greater than or equal to one week within 30 days prior to enrollment.
- Patients who have failed antifungal therapy with any systemic antifungal for this episode of candidiasis/candidemia. Recurrence within 2 weeks is considered failure of previous therapy.
- Patients with suspected Candida osteomyelitis, endocarditis, or meningitis.
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 | 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 3196127Wey SB, Mori M, Pfaller MA, Woolson RF, Wenzel RP. Hospital-acquired candidemia. The attributable mortality and excess length of stay. Arch Intern Med. 1988 Dec;148(12):2642-5. doi: 10.1001/archinte.148.12.2642.
- Background: PubMed 7548503Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. doi: 10.1093/clinids/20.6.1526.
- Background: PubMed 7948573Pfaller MA. Epidemiology and control of fungal infections. Clin Infect Dis. 1994 Aug;19 Suppl 1:S8-13. doi: 10.1093/clinids/19.supplement_1.s8.
- Derived from this study: PubMed 22026929Kett DH, Shorr AF, Reboli AC, Reisman AL, Biswas P, Schlamm HT. Anidulafungin compared with fluconazole in severely ill patients with candidemia and other forms of invasive candidiasis: support for the 2009 IDSA treatment guidelines for candidiasis. Crit Care. 2011;15(5):R253. doi: 10.1186/cc10514. Epub 2011 Oct 25.
- Derived from this study: PubMed 21961941Reboli AC, Shorr AF, Rotstein C, Pappas PG, Kett DH, Schlamm HT, Reisman AL, Biswas P, Walsh TJ. Anidulafungin compared with fluconazole for treatment of candidemia and other forms of invasive candidiasis caused by Candida albicans: a multivariate analysis of factors associated with improved outcome. BMC Infect Dis. 2011 Sep 30;11:261. doi: 10.1186/1471-2334-11-261.
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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 Anidulafungin in people with Candida 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.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 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 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 NCT00058682, which also lists 5 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.