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Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis

Primary Purpose

Cryptococcosis or Aspergillosis Infections

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
SPK-843
Sponsored by
Proaparts srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptococcosis or Aspergillosis Infections focused on measuring necrotic pulmonary infections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:The following will be included in the study:

  • Patients with proven fungal etiology confirmed by mycological culture test and by hystopathological exam ("patients with definite diagnosis"), or patients with fungal infection of which is difficult to determine the etiological agent but with diagnosis of deep mycosis based on blood testing for fungal infection and/or clinical radiological examination, and/or endoscopic clinical examination, clinical symptomatology ("patients with clinical diagnosis").
  • Patients being treated with other anti-fungal drugs (i) showing a poor response to the treatment at least after 5 days of administration of the anti-fungal drug, (ii) that have had an adverse reaction to the drug prejudicing its use, determining the risk/benefit ratio unfavorable to the patient.
  • Patients between 18 and 75 years of age.
  • Patients able to understand the content of the Informed Consent and willing to participate in the study.
  • Male and female patients.
  • Patients initially admitted to the hospitals identified for this clinical study.
  • Informed Consent.

Exclusion Criteria:

  • Patients being treated with other anti-fungal drugs with improving clinical symptoms or with an unclear clinical course.
  • Patients with intra-venous catheter and hospitalized with a diagnosis of fungemia but without clinical symptomatology twelve hours after the removal of the catheter.
  • Patients with serious deep mycosis with low change of clinical efficacy (with a high probability of death event), or with serious concomitant illnesses or with complications, which may make difficult a safety evaluation of the treatment object of this study.
  • Patients with a history of allergy to drugs like AMPH-B or with serious allergic reactions to drugs (shock after administration of drugs different from antifungals).
  • Patients with serious hepatic, and/or renal, and/or cardiac failure or basic lung disease or with functionality of the organs with the following criteria:

    • AST (GOT) or ALT (GPT) higher five (5) times the highest normal value or 200 UI/L;
    • Blood creatinine higher than 2,0 mg/dl;
    • Proteinuira (qualitative test) 3+ or greater, or a total urinary excretion of proteins (quantitative test) of 3,5 g/day or higher;
    • Hyperkalemia or hypokalemia or with a basic level of sodium of 6,0 mEq/L or greater or less than 2,5 mEq/L;
    • Hyperlipidemia with a basic value of total cholesterol greater than 1,5 times the highest normal values or 300 mg/dl, triglycerides higher than twice the highest normal values or 300 mg/dl;
    • Patients that require the infusion of leucocytes;
    • Patients with arterial thrombosis or with serious coagulative dysfunctions;
    • Patients with diabetes mellitus associated with ketosis ;
    • Pregnant women or women who intend to become pregnant, women in purperium, or breast feeding;
    • Patients that participated in a clinical study (with any type of drugs, including anti-cancer drugs) or that have been recruited for observational clinical studies with pharmaceutical agents a month before the beginning of the treatment with SPK-843;
    • Patients who, according to the doctor, are not considered fit to be recruited in the study.

Sites / Locations

  • Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e RespiratorieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Patients are males and females between 18 and 75 years of age with proven fungal etiology confirmed by mycological culture test and by hystopathological exam ("patients with definite diagnosis"), or patients with fungal infection of which is difficult to determine the etiological agent but with diagnosis of deep mycosis based on blood testing for fungal infection and/or clinical radiological examination, and/or endoscopic clinical examination, clinical symptomatology ("patients with clinical diagnosis").

Outcomes

Primary Outcome Measures

Evaluation of the overall global clinical response
Evaluation of the overall global clinical response based on secondary end points from 1 to 6 at the end of the therapy (Study day 14) and at the final visit at the end of the study - follow-up- (Study day 28) in comparison to the initial clinical state.

Secondary Outcome Measures

Evaluate the safety in the administration of SPK-843.

Full Information

First Posted
May 17, 2010
Last Updated
June 6, 2011
Sponsor
Proaparts srl
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1. Study Identification

Unique Protocol Identification Number
NCT01125644
Brief Title
Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis
Official Title
Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis. Open Label Phase III Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Proaparts srl

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recruitment of at least 10 adult patients (men and women) among individuals affected and admitted to the hospitals identified for the clinical study. All patients shall be between 18 and 75 years of age, with confirmed diagnosis of cryptococcosis or aspergillosis . During therapy (14 days) and examination (28 days), the patients will be subject to 7 doctor's visits (day 1,3,7,10,14,21, and 28).
Detailed Description
Objective: primary objective Evaluation of the overall global clinical response based on secondary end points from 1 to 6 at the end of the therapy (Study day 14) and at the final visit at the end of the study - follow-up- (Study day 28) in comparison to the initial clinical state. The evaluation will be based on: improvement/normalization in relation to the semi-quantitative scales at 3, 4 and 5 items or at opinion expressed as positive for at least 3 of the first 6 secondary end points. secondary objectives Improvement on the basis of clinical symptoms; Antifungal efficacy from the cultures; Improvement on the basis of mycological blood testing; Improvement on the basis of laboratory diagnosis (hemogasanalysis, ESR, CPR); Improvement on the basis of radiological imaging (Rx, CAT HR,…); Improvement on the basis of endoscopic examination; Evaluate the plasma levels of SPK-843 after single dose and after multiple doses; Evaluate the safety in the administration of SPK-843. Methodology: Open label multi center study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptococcosis or Aspergillosis Infections
Keywords
necrotic pulmonary infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Patients are males and females between 18 and 75 years of age with proven fungal etiology confirmed by mycological culture test and by hystopathological exam ("patients with definite diagnosis"), or patients with fungal infection of which is difficult to determine the etiological agent but with diagnosis of deep mycosis based on blood testing for fungal infection and/or clinical radiological examination, and/or endoscopic clinical examination, clinical symptomatology ("patients with clinical diagnosis").
Intervention Type
Drug
Intervention Name(s)
SPK-843
Other Intervention Name(s)
SPA-S-843
Intervention Description
SPK-843 is a semi-synthetic substance derived from Partricin A. 05 mg/Kg solution of SPK-843 in 10% intralipid will be administered i.v. in a hour for a treatment of 14 days
Primary Outcome Measure Information:
Title
Evaluation of the overall global clinical response
Description
Evaluation of the overall global clinical response based on secondary end points from 1 to 6 at the end of the therapy (Study day 14) and at the final visit at the end of the study - follow-up- (Study day 28) in comparison to the initial clinical state.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Evaluate the safety in the administration of SPK-843.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:The following will be included in the study: Patients with proven fungal etiology confirmed by mycological culture test and by hystopathological exam ("patients with definite diagnosis"), or patients with fungal infection of which is difficult to determine the etiological agent but with diagnosis of deep mycosis based on blood testing for fungal infection and/or clinical radiological examination, and/or endoscopic clinical examination, clinical symptomatology ("patients with clinical diagnosis"). Patients being treated with other anti-fungal drugs (i) showing a poor response to the treatment at least after 5 days of administration of the anti-fungal drug, (ii) that have had an adverse reaction to the drug prejudicing its use, determining the risk/benefit ratio unfavorable to the patient. Patients between 18 and 75 years of age. Patients able to understand the content of the Informed Consent and willing to participate in the study. Male and female patients. Patients initially admitted to the hospitals identified for this clinical study. Informed Consent. Exclusion Criteria: Patients being treated with other anti-fungal drugs with improving clinical symptoms or with an unclear clinical course. Patients with intra-venous catheter and hospitalized with a diagnosis of fungemia but without clinical symptomatology twelve hours after the removal of the catheter. Patients with serious deep mycosis with low change of clinical efficacy (with a high probability of death event), or with serious concomitant illnesses or with complications, which may make difficult a safety evaluation of the treatment object of this study. Patients with a history of allergy to drugs like AMPH-B or with serious allergic reactions to drugs (shock after administration of drugs different from antifungals). Patients with serious hepatic, and/or renal, and/or cardiac failure or basic lung disease or with functionality of the organs with the following criteria: AST (GOT) or ALT (GPT) higher five (5) times the highest normal value or 200 UI/L; Blood creatinine higher than 2,0 mg/dl; Proteinuira (qualitative test) 3+ or greater, or a total urinary excretion of proteins (quantitative test) of 3,5 g/day or higher; Hyperkalemia or hypokalemia or with a basic level of sodium of 6,0 mEq/L or greater or less than 2,5 mEq/L; Hyperlipidemia with a basic value of total cholesterol greater than 1,5 times the highest normal values or 300 mg/dl, triglycerides higher than twice the highest normal values or 300 mg/dl; Patients that require the infusion of leucocytes; Patients with arterial thrombosis or with serious coagulative dysfunctions; Patients with diabetes mellitus associated with ketosis ; Pregnant women or women who intend to become pregnant, women in purperium, or breast feeding; Patients that participated in a clinical study (with any type of drugs, including anti-cancer drugs) or that have been recruited for observational clinical studies with pharmaceutical agents a month before the beginning of the treatment with SPK-843; Patients who, according to the doctor, are not considered fit to be recruited in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Allegra, Ph.D
Phone
39 02 55033781
Email
luigi.allegra@unimi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Adolfo Gasparetto, Dr.
Phone
39 0429 652545
Email
adolfogasparetto@nextrasearch.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Allegra, Ph.D.
Organizational Affiliation
Ospedale Maggiore di Milano IRCCS Policlinico
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francesco Blasi, MD
Organizational Affiliation
Ospedale Maggiore di Milano IRCCS Policlinico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e Respiratorie
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Allegra, Ph.D
Phone
39 02 55033781
Email
luigi.allegra@unimi.it
First Name & Middle Initial & Last Name & Degree
Francesco Blasi, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis

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