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Trial record 28 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)

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ClinicalTrials.gov Identifier: NCT00620074
Recruitment Status : Terminated (See Detailed Description)
First Posted : February 21, 2008
Results First Posted : February 15, 2010
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aspergillosis
Interventions Drug: voriconazole
Drug: anidulafungin
Enrollment 6
Recruitment Details  
Pre-assignment Details Study was closed due to an overall low rate of enrollment after only 6 subjects enrolled.
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description

Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).

Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.

Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42.

Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description

Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).

Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.

Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 57 and 83 years Number Analyzed 6 participants
6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
1.Primary Outcome
Title Summary of Global Response at End of Treatment (EOT)
Hide Description Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Time Frame End of Treatment (Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): includes all subjects who received at least 1 dose of study medication. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin and voriconazole in combination followed by monotherapy.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Failure (No response) 1
Partial response 3
Stable response 0
Complete response 2
2.Secondary Outcome
Title Summary of Global Response at Week 2, Week 4, and Week 6
Hide Description Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Time Frame Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; due to low study enrollment, data not summarized by global response at Week 2, Week 4, and Week 6. Cross-reference outcome measure: Summary of Global Response at End of Treatment (EOT).
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin and voriconazole in combination followed by monotherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Summary of Mortality
Hide Description Number of subects with documented mortality (death).
Time Frame Up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin and voriconazole in combination followed by monotherapy.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
1
4.Secondary Outcome
Title Galactomannan Titer Assay Levels and Global Response
Hide Description Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Time Frame Up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin and voriconazole in combination followed by monotherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Voriconazole Trough Levels With Intravenous and Oral Dosing
Hide Description Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).
Time Frame Week 1 through Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; only 1 pharmacokinetic sample was collected for each subject, therefore a comprehensive analysis of trough plasma concentrations was not completed due to insufficient data.
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description:
Anidulafungin and voriconazole in combination followed by monotherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anidulalfungin and Voriconazole
Hide Arm/Group Description

Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).

Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.

Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42.

All-Cause Mortality
Anidulalfungin and Voriconazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anidulalfungin and Voriconazole
Affected / at Risk (%)
Total   4/6 (66.67%) 
General disorders   
Disease progression  1  1/6 (16.67%) 
Renal and urinary disorders   
Renal failure acute  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Hydropneumothorax  1  1/6 (16.67%) 
Pulmonary embolism  1  1/6 (16.67%) 
Respiratory failure  1  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anidulalfungin and Voriconazole
Affected / at Risk (%)
Total   6/6 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/6 (16.67%) 
Leukocytosis  1  1/6 (16.67%) 
Cardiac disorders   
Cardiac failure congestive  1  2/6 (33.33%) 
Gastrointestinal disorders   
Diarrhoea  1  1/6 (16.67%) 
Haematemesis  1  1/6 (16.67%) 
Nausea  1  1/6 (16.67%) 
Vomiting  1  2/6 (33.33%) 
General disorders   
Pyrexia  1  1/6 (16.67%) 
Infections and infestations   
Oropharyngeal candidiasis  1  1/6 (16.67%) 
Investigations   
Blood glucose increased  1  1/6 (16.67%) 
Blood magnesium decreased  1  1/6 (16.67%) 
Blood potassium increased  1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Acidosis  1  1/6 (16.67%) 
Hyperphosphataemia  1  1/6 (16.67%) 
Hypocalcaemia  1  1/6 (16.67%) 
Hypoglycaemia  1  1/6 (16.67%) 
Hypophosphataemia  1  1/6 (16.67%) 
Metabolic alkalosis  1  1/6 (16.67%) 
Psychiatric disorders   
Anxiety  1  1/6 (16.67%) 
Mental status changes  1  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  1/6 (16.67%) 
Subcutaneous emphysema  1  1/6 (16.67%) 
Vascular disorders   
Deep vein thrombosis  1  1/6 (16.67%) 
Subclavian vein thrombosis  1  1/6 (16.67%) 
Venous thrombosis limb  1  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Due to low enrollment and early termination of the study, data was insufficient for descriptive or inferential analysis as planned; no significant treatment-related safety results were identified in the subjects treated with combination therapy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00620074     History of Changes
Other Study ID Numbers: A8851014
First Submitted: February 8, 2008
First Posted: February 21, 2008
Results First Submitted: January 21, 2010
Results First Posted: February 15, 2010
Last Update Posted: February 15, 2010