MDACC Study Summary 2007-0413 (Archived)

Study Summary
No. 2007-0413:.......Infection......Victor Mulanovich......Infectious Disease

Study Summary Title



Study Summary Number:	2007-0413

Study Title:	Phase IV Open-Label Non-Comparative Trial of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment of Candidemia and Invasive Candidiasis

Physician

New Patient Referral



Name:	Victor Mulanovich	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Infectious Disease	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6237 Contact us about clinical trials

General Information



Disease Group:	Infection	Supported By:	Pfizer

Phase of Study:	Phase IV	Return Visit:	They must come back once a week up to day 42.

Treatment Agents:	Anidulafungin Fluconazole Voriconazole	Home Care:	NA

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	5 - 28 days for hospitalization, depending on the patients response to treatment.


Description/ Intervention:	The goal of this clinical research study is to learn if Eraxis™ (anidulafungin) when given before either fluconazole or voriconazole can help to control Candida. The safety of this drug will also be studied.

Study Objectives / Outcomes

The trial objectives are to collect data on efficacy, safety and tolerability of anidulafungin, for at least five days, followed by oral azole therapy with either fluconazole or voriconazole in subjects with invasive candidiasis or candidemia.

Although there will be a focus on evaluating efficacy in the treatment of infections caused by C. albicans, those with infections caused by non-albicans Candida spp. will qualify for inclusion in this study.

Secondary objectives:

To evaluate the efficacy of anidulafungin treatment in the subset of subjects with non-albicans Candida infections.

To assess safety and tolerability of anidulafungin utilizing laboratory assay results and adverse events listings, including mortality.

To evaluate the presence of a global response at the End of IV Treatment (EOIV).

To evaluate the presence of a sustained global response at Week 2 and Week 6 follow-up visits.

To evaluate the time to negative blood/tissue culture.

To explore a possible correlation between ā-D-glucan assay results and blood/tissue culture results.

To assess health outcome impact as determined with review of data relevant to outpatient and inpatient Medical Resource Utilization (MRU). MRU data collection will include the length of hospital stay, medically dischargeable status, hospitalization status, discharge destination, hospital re-admission(s), and start and stop time of study drug and antifungal medications used to treat acute candidemia/candidiasis.

To assess all cause and attributable mortality (copies of death certificates, autopsy reports or hospital summaries will be collected whenever possible/available).

To assess the plasma pharmacokinetics of anidulafungin through sparse sampling, and to explore the pharmacokinetic-pharmacodynamic relationship of anidulafungin in a subset of patients.

Study Status Information



Study Activation / Registration Date:	07/09/2008

IRB Review and Approval Date:	03/20/2008

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	286

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Male or female subjects greater than or equal to 18 years of age.

2) Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours:

3) Candidemia: at least one blood culture positive for yeast.

4) Other forms of invasive candidiasis: positive culture for yeast from a normally sterile site with or without a positive blood culture. Specific examples are as follows: A. Positive culture for yeast from a newly placed drain in a normally sterile site; B. Positive culture for yeast from a specimen from a normally sterile site.

5) Presence of 1 or more of the following signs & symptoms of fungal infection: Fever defined as oral/tympanic temperature >/= 38 degree C (100.4 degree F); rectal/core temperature >/= 38.6 degree C (101.4 degree F); or axillary temperature >/= 99.4 degree F. Hypothermia defined as core temperature < 96.8 degreeF (36.0 degree C). Hypotension (systolic blood pressure [SBP] <100 mmHg, or SBP decrease >/= 30 mm Hg from baseline). Localized signs & symptoms of inflammation (swelling, heat erythema or purulence at a site infected with Candida spp.) or radiological findings of invasive candidiasis

6) Subjects willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patient's behalf.

7) Subjects on previous/current azole therapy administered as prophylaxis may be enrolled provided the medication is discontinued prior to initiating study drug treatment.

8) Subjects who received no more than a single dose of echinocandin therapy prior to study entry may be enrolled. Subjects who received no more than 48 hours of systemic azole for treatment (including empirical therapy) of the current Candida infection may be enrolled provided the azole is discontinued prior to initiating study drug treatment.

9) Subjects who received no more than a single dose of amphotericin B prior to study entry may be enrolled.

10) Expected survival (in the opinion of the investigator) of greater than 1 month.

Exclusion Criteria:

1) Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.

2) Subjects who failed treatment for the current episode of candidemia and/or invasive candidiasis with any systemic antifungal agent.

3) Subjects who are participating or have participated within the last 30 days in a trial with other investigational drug(s). Subjects on antiretroviral or chemotherapy regimens which include an investigational drug may participate provided that there has been no change in their therapy during the past 4 weeks and no change in treatment is anticipated during study participation.

4) Subjects with a diagnosis of fungal endophthalmitis with involvement of the vitreous.

5) Subjects with chronic refractory neutropenia who are not expected to recover, (defined as ANC < 500 cells/mm^3 for 28 days prior to the baseline visit).

6) Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.

7) Women of child bearing potential, who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, or are currently breastfeeding.

8) Subjects with prosthetic devices, as suspected sites of infection, are excluded unless the device is removed within 24 hours of study entry.

9) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Links

Registration Number: NCT00496197
Study Information on Clinical Trials Registry (clinicaltrials.gov)