Ignite Creation Date:
2024-05-05 @ 10:30 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01125644
Status:
UNKNOWN
Last Update Posted:
2011-06-08
First Post:
2010-05-17
Brief Title:
Efficacy Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis
Sponsor:
Proaparts srl
Organization:
Proaparts srl
Study Overview
Official Title:
Efficacy Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis Open Label Phase III Clinical Study
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 doctors visits day 137101421 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 improvementnormalization 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
The evaluation will be based on improvementnormalization 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None