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

NCT00548262 | Completed Phase 4 Results

• 1 other identifier: A8851015
• Study Type: interventional
• Target: 54
• Locations: 5 countries
• Sites: 13

Brief 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.

Conditions

Candidemia; Invasive Candidiasis

Keywords

Open-label; non-comparative study to evaluate short course of IV anidulafungin; followed by oral voriconazole; for tx of candidemia/invasive candidiasis.

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (21)

• Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)

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

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

  Baseline, EIVT (up to Day 42)

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

  Baseline, EOT (up to Day 42)

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

  Baseline, Week 2 Follow-up

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

  Baseline, EOT (up to Day 42)

Study Arms (1)

1

EXPERIMENTAL

Drug: Anidulafungin; Drug: Voriconazole

Interventions

Anidulafungin DRUG

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.

Also known as: Eraxis

1

Voriconazole DRUG

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).

Also known as: Vfend

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Pfizer Investigational Site

Brasília, Federal District, 70710-905, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80060-900, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Independencia, Santiago, RM, 8380456, Chile

Location

Pfizer Investigational Site

Bogota DC, Cundinamarca, 0000, Colombia

Location

Pfizer Investigational Site

Cali, Valle del Cauca Department, 0000, Colombia

Location

Pfizer Investigational Site

León, Guanajuato, 37320, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44280, Mexico

Location

Pfizer Investigational Site

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Pfizer Investigational Site

Panama City, Panama

Location

Related Publications (5)

• 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.

  PMID: 33891293 DERIVED

• 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.

  PMID: 31280481 DERIVED

• 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.

  PMID: 28597967 DERIVED

• 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.

  PMID: 28459966 DERIVED

• 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.

  PMID: 23710653 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Candidemia; Candidiasis, Invasive

Interventions

Anidulafungin; Voriconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Protocol registration indicated timeframes for EIVT and/or Week 2 F/U for time to event, mortality, vital signs, and labs; however, analyses were continuous and reported from baseline to EIVT (up to Day 42), Week 2 F/U, or Week 6 telephone F/U visit.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 23, 2007
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 17, 2011
• Results First Posted: January 17, 2011

Record last verified: 2010-12

Locations

CL (1); BR (6); CO (2); ME (3); PA (1)