Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis
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).
|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|
- 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.
- Evaluate the safety in the administration of SPK-843. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|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)|
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").
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
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.
- 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
|Contact: Luigi Allegra, Ph.D||39 02 email@example.com|
|Contact: Adolfo Gasparetto, Dr.||39 0429 firstname.lastname@example.org|
|Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e Respiratorie||Recruiting|
|Milan, Italy, 20122|
|Contact: Luigi Allegra, Ph.D 39 02 55033781 email@example.com|
|Principal Investigator: Francesco Blasi, MD|
|Study Director:||Luigi Allegra, Ph.D.||Ospedale Maggiore di Milano IRCCS Policlinico|
|Principal Investigator:||Francesco Blasi, MD||Ospedale Maggiore di Milano IRCCS Policlinico|