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CandidemiaPhase 4NCT00548262

This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

A Phase 4 study testing Anidulafungin and Voriconazole in people with Candidemia and Invasive Candidiasis, run by Pfizer at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidemia, Invasive Candidiasis
What is being tested?
Anidulafungin and Voriconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
13 sitesin 5 countries
Study dates
Feb 2008to Oct 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Male or female patient 18 years of age and older.
  • If female, must be post-menopausal, surgically sterile or using adequate contraception,not lactating, and have a negative urine or blood pregnancy test at screening, prior to administration of study medication.
  • 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 to study entry ((informed consent provided).
  • Presence of one or more of the following signs and symptoms of acute fungal infection within the prior 48 hours to initiation of study treatment:
  • Fever defined as oral temperature greater than or equal to 38 degrees C (100.4 degrees F); rectal or core temperature greater than or equal to 38.6 degrees C (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less than 36.0 degrees C (96.8 degrees F).
  • Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease greater than or equal to 30 mm Hg from baseline.
Show all 11Show fewer
  • Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.).
  • Patient is classified in one of following categories based on previous antifungal treatment: received less than 48 hours of previous systemic antifungal therapy and no more than a single dose of echinocandin therapy prior to study entry; intolerant to infusion related toxicities of amphotericin B preparations despite appropriate supportive measures or serum creatinine increased by >1.5 mg/dl while receiving conventional or lipid amphotericin B therapy; or lack of clinical response and/or persistent positive blood culture after at least seven days of systemic antifungal treatment with a polyene or fluconazole at an adequate dose.
  • APACHE II 9 score < 25 at study entry.
  • Patients willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patients behalf.
  • Expected survival (in the opinion of the investigator) greater than 4 days.

Who cannot join

  • Hypersensitivity to anidulafungin, other echinocandins or azoles.
  • Participation presently or within the last 30 days in a trial with other investigational drug(s). Patients 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.
  • Chronic refractory neutropenia defined as absolute neutrophils count <500 cells/mm3 for 28 days prior to the baseline visit.
  • Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
  • Poor venous access that would preclude IV drug delivery or multiple blood draws.
  • Prosthetic devices at a suspected site of infection unless the device is removed within 24 hours of study entry.
  • Fungal endophthalmitis confirmed by fundoscopy.
  • 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 Patient inappropriate for entry into this trial.

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

Brazil6 sites
  • Pfizer Investigational Site

    Brasília, Federal District, 70710-905

  • Pfizer Investigational Site

    Curitiba, Paraná, 80060-900

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Pfizer Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Mexico3 sites
  • Pfizer Investigational Site

    Guadalajara, Jalisco, 44280

  • Pfizer Investigational Site

    León, Guanajuato, 37320

  • Pfizer Investigational Site

    San Luis Potosí City, San Luis Potosí, 78240

Other trials in Mexico

Colombia2 sites
  • Pfizer Investigational Site

    Bogota DC, Cundinamarca, 0000

  • Pfizer Investigational Site

    Cali, Valle del Cauca Department, 0000

Other trials in Colombia

Chile1 site
  • Pfizer Investigational Site

    Independencia, Santiago, RM, 8380456

Other trials in Chile

Panama1 site
  • Pfizer Investigational Site

    Panama City

Other trials in Panama

About this study

Official title: Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Hospitalized Patients

The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

Being tested
Anidulafungin, Voriconazole
Keywords
Open-label, non-comparative study to evaluate short course of IV anidulafungin, followed by oral voriconazole, for tx of candidemia/invasive candidiasis.
Medical subject headings
Candidemia, Candidiasis, Invasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnidulafunginDrug

    Also called Eraxis

    All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.

  • VoriconazoleDrug

    Also called Vfend

    Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if <40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if <40 kg body weight).

Study groups in NCT00548262
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Anidulafungin; Drug: Voriconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment

    Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).

    Measured: End of Treatment (EOT) (up to Day 42)

Secondary outcomes (21)
  1. Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)

    Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).

    Measured: End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up

  2. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.

    Measured: Baseline, EIVT (up to Day 42)

  3. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.

    Measured: Baseline, EOT (up to Day 42)

  4. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.

    Measured: Baseline, Week 2 Follow-up

  5. Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    Measured: Baseline, EOT (up to Day 42)

  6. Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    Measured: EIVT (up to Day 42)

  7. Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    Measured: Baseline, Week 2 Follow-up (F/U)

  8. Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.

    Measured: EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up

  9. Number of Participants Per Survival Status (Alive or Dead) on Day 30

    Measured: Day 30

  10. Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis

    Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.

    Measured: Baseline to Week 6 Follow-up

  11. Time to Negative Blood, Specimen, or Tissue Culture

    Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).

    Measured: Baseline to Week 2 Follow-up

  12. Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment

    Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.

    Measured: Baseline to Day 42

  13. Length of Hospital Stay

    Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.

    Measured: Baseline to Week 6 Follow-up

  14. Length of Stay in Intensive Care Unit (ICU)

    Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.

    Measured: Baseline up to Week 6 Follow-up

  15. Change From Baseline in Vital Signs: Supine Blood Pressure

    Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).

    Measured: Baseline to Week 2 Follow-up

  16. Change From Baseline in Vital Signs: Supine Heart Rate

    Supine heart rate measured as beats per minute (bpm).

    Measured: Baseline to Week 2 Follow-up

  17. Change From Baseline in Vital Signs: Weight

    Weight measured as kilograms (kg).

    Measured: Baseline to Week 2 Follow-up

  18. Change From Baseline in Vital Signs: Temperature

    Temperature measured as degrees of Celsius (C).

    Measured: Baseline to Week 2 Follow-up

  19. Change From Baseline in Vital Signs: Respiration Rate

    Respiration rate measured as respirations per minute (resp/min).

    Measured: Baseline to Week 2 Follow-up

  20. Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)

    Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).

    Measured: Baseline to Week 2 Follow-up

  21. Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)

    Chemistry laboratory test data measured as international units per (IU/L).

    Measured: Baseline to Week 2 Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00548262
Sponsor's protocol ID
A8851015
Status last verified
Dec 2010
First submitted
19 Oct 2007
Last updated
17 Jan 2011
Data monitoring committee
No

Publications

  • De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.

    PubMed 33891293
  • Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.

    PubMed 31280481
  • Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.

    PubMed 28597967
  • Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.

    PubMed 28459966
  • Nucci M, Colombo AL, Petti M, Magana M, Abreu P, Schlamm HT, Sanchez SP. An open-label study of anidulafungin for the treatment of candidaemia/invasive candidiasis in Latin America. Mycoses. 2014 Jan;57(1):12-8. doi: 10.1111/myc.12094. Epub 2013 May 26.

    PubMed 23710653

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anidulafungin and Voriconazole in people with Candidemia and Invasive Candidiasis, run by Pfizer at 13 sites in 5 countries.

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 11 inclusion and 8 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 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Brazil, Mexico, Colombia, Chile, Panama. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment (time frame: End of Treatment (EOT) (up to Day 42)). 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 NCT00548262, 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 17 Jan 2011.

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