Hematologic MalignanciesPhase 2ECALTANCT01053884
Anidulafungin in Patients With Hematologic Malignancies
A Phase 2 study testing Anidulafungin in people with Hematologic Malignancies, run by Elisabethinen Hospital at 1 site in Austria.
Trial summary
Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or treatment of invasive fungal infections (IFI) in hematologic patients. Study design, Study conduct period Prospective, open label, phase II, one arm, single centre study October 2009 - September 2010 Study population Twenty… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Anidulafungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2009to Sep 2011
- 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
- Adult patients (≥ 18 years) with a hematologic disorder AND an indication for IFI prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic or renal dysfunction*, are scheduled to receive anidulafungin for one of the following specific indications:
- Need for primary antifungal prophylaxis in patients with Acute leucaemia/MDS during induction, reinduction or consolidation chemotherapy (who are expected to become neutropenic for at least 10 days) OR after allogenic HSCT with GvHD (at least grade II or more - systemic steroid treatment required)
- Need for secondary antifungal prophylaxis in patients with the history of a proven or probable invasive fungal infection who are expected to become neutropenic during induction, reinduction or consolidation chemotherapy
- Indication for treatment of proven**, probable or possible fungal infection:
- Neutropenic patients with fever resistant to antibiotics (empirical use)
- Neutropenic patients with fever resistant to antibiotics and additive laboratory or imaging signs of IFI (preemptive use)
- Patients who failed other antifungal therapy due to intolerance or progressive infection
Who cannot join
- Absence of written informed consent
- Female patients who are pregnant or lactating
- Use of anidulafungin within 30 days prior to study
- Known hypersensitivity to anidulafungin
- Proven IFI with pathogen of known resistance to echinocandins (e.g. zygomycetes)
- Life expectancy less than 1 month
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anidulafungin in Patients With Hematologic Malignancies - An Open-label, Prospective Study to Evaluate the Safety Profile at Prophylactic and Therapeutic Dosages
Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or treatment of invasive fungal infections (IFI) in hematologic patients.
Study design, Study conduct period Prospective, open label, phase II, one arm, single centre study October 2009 - September 2010
Read more
Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic and renal dysfunction respectively
Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes of important laboratory parameters with clinical impact will be reported.
Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized into success or failure. For patients receiving anidulafungin as prophylaxis the number and rate of breakthrough infections will be documented.
Risk assessment Treatment related adverse effects as reported in the approved physician prescribing information (usually mild and with an incidence of < 5%). Treatment failure due to resistant pathogens.
Expected benefit from this study IFI is a major cause of death among hematological patients, especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a new treatment option for patients in whom azoles or polyenes are relatively contraindicated.
Read the detailed description
Treatment of patients with hematologic disorders is frequently complicated by invasive fungal infections (IFI). The current spectrum of pathogens in this patient population is characterised by an increasing rate of aspergillosis, atypical moulds and yeasts, which might be explained by an extended application of myelosuppressive chemotherapy and prophylactic use of antibiotic therapy, but also more sensitive diagnostic tools. Although several new antifungal drugs have been approved recently for the treatment of invasive fungal infections, the mortality rates remain unacceptably high. In patients with suspected IFI invasive diagnostic procedures can often not be performed due to thrombocytopenia and blood testing of fungal antigens with ELISA or PCR-methods are at most additive tools at this time. Thus, antifungal drugs are frequently applied empirically when neutropenic fever persists despite of antibiotic therapy or preemptive in case of radiological or laboratory suspicion of IFI. The antifungal armamentarium consists mainly of azoles, polyenes, and echinocandins. Therapy with azoles is frequently complicated by hepatological side effects and drug interactions, whereas the application of polyenes is often associated with a worsening of the renal function, severe hypopotassemia and shivering. Because of their favourable efficacy and outstanding safety profile, nowadays echinocandins are increasingly used in hematologic wards, especially in patients with renal or liver comorbidity. Anidulafungin is a novel echinocandin with potent invitro fungicidal activity against several pathogen yeasts and moulds like Candida- or Aspergillus spp. It has recently been approved by the EMEA for treatment of invasive candidiasis in non-neutropenic patients. A low cytochrome P450 interaction profile has been reported and dose adaption in case of hepatical or renal impairment is not recommended. In the pivotal clinical trial anidulafungin achieved a superior response rate for treatment of invasive candida infection in comparison with fluconazole. In this trial, only a quarter of patients had cancer and only 3% had neutrophil counts below 500/cm3 blood at randomisation. Although the clinical experience of the efficacy and tolerability of anidulafungin in adult hematologic patients is limited, the Infectious Diseases Society of America recently recommended anidulafungin for use in neutropenic patients with candidiasis.
Primary endpoint:
Safety: For all patients who will receive anidulafungin without regard to indication the incidence of (serious) adverse events and changes of important laboratory parameters (in particular liver and renal function parameters) with clinical impact will be reported.
Secondary endpoints:
Pharmacokinetics Efficacy
For patients receiving anidulafungin as prophylaxis the number and rate of breakthrough infections will be reported. If breakthrough infection occurs the type of salvage therapy and the outcome will also be documented. For patients receiving anidulafungin as treatment of a current episode of a fungal infection the primary efficacy outcome is defined as the proportion of patients alive at week six after inclusion in the study or at the time that a patient is censored. A second evaluation of survival will be done at week 12. Reason of death will be analyzed according to toxicity of study drug and progression of IFI, respectively.
The efficacy outcome will be categorized into the following:
Success:
Complete response: Survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease and radiological abnormalities, and mycological evidence of eradication of disease.
Partial response: Survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease and radiological abnormalities, and evidence of clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.
Failure: Stable response: Survival within the prespecified period of observation and minor or no improvement in fungal disease, but no evidence of progression, as determined on the basis of a composite of clinical, radiological, and mycological criteria.
Progression: Evidence of progressive fungal disease based on a composite of clinical, radiological, and mycological criteria.
Death: Death during the prespecified period of evaluation, regardless of attribution.
Survival data (overall mortality and attributable mortality, if applicable) for all patients and the time-to-negativity of a blood culture will be reported in this study.
- Conditions
- Hematologic Malignancies
- Being tested
- Anidulafungin
- Keywords
- Invasive Candidiasis, invasive fungal disease, Anidulafungin
- Medical subject headings
- Hematologic Neoplasms, Candidiasis, Invasive, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnidulafunginDrug
Also called Ecalta
standard dose: 200mg/d on day 1, followed by 100mg/d from day 2 as maintenance dose.
Prophylaxis will be given until the recovery from neutropenia (ANC > 1,0 G/L without myelosupportive medications) and in cases of active fungal infection until best response, in case of fungemia for at least 2 weeks after the first negative culture.
| Study group | Role | What they receive |
|---|---|---|
| Anidulafungin, safety, antifungal drug | Other | single arm study Receives: Drug: Anidulafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of (serious)adverse events and changes of important laboratory parameters (in particular liver and renal function parameters) with clinical impact will be reported.
Measured: day 1-5, 10 , end of treatment and study.
Secondary outcomes (1)
pharmacokinetics and efficacy: As prophylaxis: the number of breakthrough infections. As treatment: complete and partial response rate (success); stable, progression and death (Failure)
Measured: day 5 (pharmacokinetics), end of treatment, week 6 and 12 (efficacy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: reduced recruitment rate due to non infectious, but competitive trials at our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisabethinen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Michael Girschikofsky, Elisabethinen Hospital
- Investigators
- Michael Girschikofsky, MD, Study chair, Elisabethinen hospital Linz GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053884
- Sponsor's protocol ID
- Anidulafungin - MG-ECALTA1
- Other IDs
- 2009-014527-23, 2009
- Acronym
- ECALTA
- Status last verified
- Jul 2009
- First submitted
- 15 Jan 2010
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Damle BD, Dowell JA, Walsky RL, Weber GL, Stogniew M, Inskeep PB. In vitro and in vivo studies to characterize the clearance mechanism and potential cytochrome P450 interactions of anidulafungin. Antimicrob Agents Chemother. 2009 Mar;53(3):1149-56. doi: 10.1128/AAC.01279-08. Epub 2008 Nov 24.
PubMed 19029327Krause DS, Reinhardt J, Vazquez JA, Reboli A, Goldstein BP, Wible M, Henkel T; Anidulafungin Invasive Candidiasis Study Group. Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. Antimicrob Agents Chemother. 2004 Jun;48(6):2021-4. doi: 10.1128/AAC.48.6.2021-2024.2004.
PubMed 15155194Pappas PG, Kauffman CA, Andes D, Benjamin DK Jr, Calandra TF, Edwards JE Jr, Filler SG, Fisher JF, Kullberg BJ, Ostrosky-Zeichner L, Reboli AC, Rex JH, Walsh TJ, Sobel JD; Infectious Diseases Society of America. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Mar 1;48(5):503-35. doi: 10.1086/596757.
PubMed 19191635Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. doi: 10.1056/NEJMoa066906.
PubMed 17568028De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Munoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21. doi: 10.1086/588660.
PubMed 18462102Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, Walsh TJ, Maertens J, Patterson TF, Perfect JR, Dupont B, Wingard JR, Calandra T, Kauffman CA, Graybill JR, Baden LR, Pappas PG, Bennett JE, Kontoyiannis DP, Cordonnier C, Viviani MA, Bille J, Almyroudis NG, Wheat LJ, Graninger W, Bow EJ, Holland SM, Kullberg BJ, Dismukes WE, De Pauw BE. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. 2008 Sep 1;47(5):674-83. doi: 10.1086/590566.
PubMed 18637757Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
PubMed 7165009
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anidulafungin in Patients With Hematologic Malignancies - An Open-label, Prospective Study to Evaluate the Safety Profile at Prophylactic and Therapeutic Dosages
- ClinicalTrials.gov ID
- NCT01053884
- Acronym / sponsor ID
- ECALTA / Anidulafungin - MG-ECALTA1
- Conditions
- Hematologic Malignancies
- Keywords
- Invasive Candidiasis, invasive fungal disease, Anidulafungin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reduced recruitment rate due to non infectious, but competitive trials at our institution
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Elisabethinen HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Jan 2010 (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.
Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or treatment of invasive fungal infections (IFI) in hematologic patients.
Study design, Study conduct period Prospective, open label, phase II, one arm, single centre study October 2009 - September 2010
Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic and renal dysfunction respectively
Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes of important laboratory parameters with clinical impact will be reported.
Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized into success or failure. For patients receiving anidulafungin as prophylaxis the number and rate of breakthrough infections will be documented.
Risk assessment Treatment related adverse effects as reported in the approved physician prescribing information (usually mild and with an incidence of < 5%). Treatment failure due to resistant pathogens.
Expected benefit from this study IFI is a major cause of death among hematological patients, especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a new treatment option for patients in whom azoles or polyenes are relatively contraindicated.
Detailed description
Treatment of patients with hematologic disorders is frequently complicated by invasive fungal infections (IFI). The current spectrum of pathogens in this patient population is characterised by an increasing rate of aspergillosis, atypical moulds and yeasts, which might be explained by an extended application of myelosuppressive chemotherapy and prophylactic use of antibiotic therapy, but also more sensitive diagnostic tools. Although several new antifungal drugs have been approved recently for the treatment of invasive fungal infections, the mortality rates remain unacceptably high. In patients with suspected IFI invasive diagnostic procedures can often not be performed due to thrombocytopenia and blood testing of fungal antigens with ELISA or PCR-methods are at most additive tools at this time. Thus, antifungal drugs are frequently applied empirically when neutropenic fever persists despite of antibiotic therapy or preemptive in case of radiological or laboratory suspicion of IFI. The antifungal armamentarium consists mainly of azoles, polyenes, and echinocandins. Therapy with azoles is frequently complicated by hepatological side effects and drug interactions, whereas the application of polyenes is often associated with a worsening of the renal function, severe hypopotassemia and shivering. Because of their favourable efficacy and outstanding safety profile, nowadays echinocandins are increasingly used in hematologic wards, especially in patients with renal or liver comorbidity. Anidulafungin is a novel echinocandin with potent invitro fungicidal activity against several pathogen yeasts and moulds like Candida- or Aspergillus spp. It has recently been approved by the EMEA for treatment of invasive candidiasis in non-neutropenic patients. A low cytochrome P450 interaction profile has been reported and dose adaption in case of hepatical or renal impairment is not recommended. In the pivotal clinical trial anidulafungin achieved a superior response rate for treatment of invasive candida infection in comparison with fluconazole. In this trial, only a quarter of patients had cancer and only 3% had neutrophil counts below 500/cm3 blood at randomisation. Although the clinical experience of the efficacy and tolerability of anidulafungin in adult hematologic patients is limited, the Infectious Diseases Society of America recently recommended anidulafungin for use in neutropenic patients with candidiasis.
Primary endpoint:
Safety: For all patients who will receive anidulafungin without regard to indication the incidence of (serious) adverse events and changes of important laboratory parameters (in particular liver and renal function parameters) with clinical impact will be reported.
Secondary endpoints:
Pharmacokinetics Efficacy
For patients receiving anidulafungin as prophylaxis the number and rate of breakthrough infections will be reported. If breakthrough infection occurs the type of salvage therapy and the outcome will also be documented. For patients receiving anidulafungin as treatment of a current episode of a fungal infection the primary efficacy outcome is defined as the proportion of patients alive at week six after inclusion in the study or at the time that a patient is censored. A second evaluation of survival will be done at week 12. Reason of death will be analyzed according to toxicity of study drug and progression of IFI, respectively.
The efficacy outcome will be categorized into the following:
Success:
Complete response: Survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease and radiological abnormalities, and mycological evidence of eradication of disease.
Partial response: Survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease and radiological abnormalities, and evidence of clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.
Failure: Stable response: Survival within the prespecified period of observation and minor or no improvement in fungal disease, but no evidence of progression, as determined on the basis of a composite of clinical, radiological, and mycological criteria.
Progression: Evidence of progressive fungal disease based on a composite of clinical, radiological, and mycological criteria.
Death: Death during the prespecified period of evaluation, regardless of attribution.
Survival data (overall mortality and attributable mortality, if applicable) for all patients and the time-to-negativity of a blood culture will be reported in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anidulafungin, safety, antifungal drug | Other | Drug: Anidulafunginsingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (≥ 18 years) with a hematologic disorder AND an indication for IFI prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic or renal dysfunction*, are scheduled to receive anidulafungin for one of the following specific indications:
- Need for primary antifungal prophylaxis in patients with Acute leucaemia/MDS during induction, reinduction or consolidation chemotherapy (who are expected to become neutropenic for at least 10 days) OR after allogenic HSCT with GvHD (at least grade II or more - systemic steroid treatment required)
- Need for secondary antifungal prophylaxis in patients with the history of a proven or probable invasive fungal infection who are expected to become neutropenic during induction, reinduction or consolidation chemotherapy
- Indication for treatment of proven**, probable or possible fungal infection:
Key exclusion criteria (7 listed)
- Absence of written informed consent
- Female patients who are pregnant or lactating
- Use of anidulafungin within 30 days prior to study
- Known hypersensitivity to anidulafungin
- Proven IFI with pathogen of known resistance to echinocandins (e.g. zygomycetes)
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 |
|---|---|---|
| AnidulafunginAlso: Ecaltastandard dose: 200mg/d on day 1, followed by 100mg/d from day 2 as maintenance dose. Prophylaxis will be given until the recovery from neutropenia (ANC > 1,0 G/L without myelosupportive medications) and in cases of active fungal infection until best response, in case of fungemia for at least 2 weeks after the first negative culture. | Drug | Anidulafungin, safety, antifungal drug |
Primary outcome
Safety: incidence of (serious)adverse events and changes of important laboratory parameters (in particular liver and renal function parameters) with clinical impact will be reported.
Time frame: day 1-5, 10 , end of treatment and study.
1 secondary outcome
pharmacokinetics and efficacy: As prophylaxis: the number of breakthrough infections. As treatment: complete and partial response rate (success); stable, progression and death (Failure)
Time frame: day 5 (pharmacokinetics), end of treatment, week 6 and 12 (efficacy)
Results and safety
The study was stopped early (reason given: reduced recruitment rate due to non infectious, but competitive trials at our institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
- Background: PubMed 19029327Damle BD, Dowell JA, Walsky RL, Weber GL, Stogniew M, Inskeep PB. In vitro and in vivo studies to characterize the clearance mechanism and potential cytochrome P450 interactions of anidulafungin. Antimicrob Agents Chemother. 2009 Mar;53(3):1149-56. doi: 10.1128/AAC.01279-08. Epub 2008 Nov 24.
- Background: PubMed 15155194Krause DS, Reinhardt J, Vazquez JA, Reboli A, Goldstein BP, Wible M, Henkel T; Anidulafungin Invasive Candidiasis Study Group. Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. Antimicrob Agents Chemother. 2004 Jun;48(6):2021-4. doi: 10.1128/AAC.48.6.2021-2024.2004.
- Background: PubMed 19191635Pappas PG, Kauffman CA, Andes D, Benjamin DK Jr, Calandra TF, Edwards JE Jr, Filler SG, Fisher JF, Kullberg BJ, Ostrosky-Zeichner L, Reboli AC, Rex JH, Walsh TJ, Sobel JD; Infectious Diseases Society of America. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Mar 1;48(5):503-35. doi: 10.1086/596757.
- Background: PubMed 17568028Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. doi: 10.1056/NEJMoa066906.
- Background: PubMed 18462102De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Munoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21. doi: 10.1086/588660.
- Background: PubMed 18637757Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, Walsh TJ, Maertens J, Patterson TF, Perfect JR, Dupont B, Wingard JR, Calandra T, Kauffman CA, Graybill JR, Baden LR, Pappas PG, Bennett JE, Kontoyiannis DP, Cordonnier C, Viviani MA, Bille J, Almyroudis NG, Wheat LJ, Graninger W, Bow EJ, Holland SM, Kullberg BJ, Dismukes WE, De Pauw BE. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. 2008 Sep 1;47(5):674-83. doi: 10.1086/590566.
- Background: PubMed 7165009Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
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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.
Michael Girschikofsky, MD study chair
Elisabethinen hospital Linz GmbH
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 in people with Hematologic Malignancies, run by Elisabethinen Hospital at 1 site in Austria.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Mar 2012. 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 Austria. 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 was stopped early (reason given: reduced recruitment rate due to non infectious, but competitive trials at our institution). Results are not available in the source record.
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?
Safety: incidence of (serious)adverse events and changes of important laboratory parameters (in particular liver and renal function parameters) with clinical impact will be reported. (time frame: day 1-5, 10 , end of treatment and study.). 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 NCT01053884, which also lists 7 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 2 Mar 2012.