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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Proaparts srl.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Proaparts srl
ClinicalTrials.gov Identifier:
NCT01125644
First received: May 17, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
Cryptococcosis or Aspergillosis Infections
Drug: SPK-843
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis. Open Label Phase III Clinical Study

Resource links provided by NLM:


Further study details as provided by Proaparts srl:

Primary Outcome Measures:
  • Evaluation of the overall global clinical response [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
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").
Drug: SPK-843
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
Other Name: SPA-S-843

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

  1. Improvement on the basis of clinical symptoms;
  2. Antifungal efficacy from the cultures;
  3. Improvement on the basis of mycological blood testing;
  4. Improvement on the basis of laboratory diagnosis (hemogasanalysis, ESR, CPR);
  5. Improvement on the basis of radiological imaging (Rx, CAT HR,…);
  6. Improvement on the basis of endoscopic examination;
  7. Evaluate the plasma levels of SPK-843 after single dose and after multiple doses;
  8. Evaluate the safety in the administration of SPK-843.

Methodology: Open label multi center study

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125644

Contacts
Contact: Luigi Allegra, Ph.D 39 02 55033781 luigi.allegra@unimi.it
Contact: Adolfo Gasparetto, Dr. 39 0429 652545 adolfogasparetto@nextrasearch.it

Locations
Italy
Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e Respiratorie Recruiting
Milan, Italy, 20122
Contact: Luigi Allegra, Ph.D    39 02 55033781    luigi.allegra@unimi.it   
Principal Investigator: Francesco Blasi, MD         
Sponsors and Collaborators
Proaparts srl
Investigators
Study Director: Luigi Allegra, Ph.D. Ospedale Maggiore di Milano IRCCS Policlinico
Principal Investigator: Francesco Blasi, MD Ospedale Maggiore di Milano IRCCS Policlinico
  More Information

No publications provided

Responsible Party: Tiberio Bruzzese, Proaparts srl
ClinicalTrials.gov Identifier: NCT01125644     History of Changes
Other Study ID Numbers: SPK-843-03/01
Study First Received: May 17, 2010
Last Updated: June 6, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Proaparts srl:
necrotic pulmonary infections

Additional relevant MeSH terms:
Aspergillosis
Cryptococcosis
Mycoses

ClinicalTrials.gov processed this record on July 20, 2014