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

2014-08-27 03:13:35 | BioPortfolio

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).

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

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cryptococcosis or Aspergillosis Infections

Intervention

SPK-843

Location

Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e Respiratorie
Milan
Italy
20122

Status

Recruiting

Source

Proaparts srl

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:35-0400

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