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

NCT01125644 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-06-08

No results posted yet for this study

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).

Conditions

  • Cryptococcosis or Aspergillosis Infections

Interventions

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

Sponsors & Collaborators

  • Proaparts srl

    lead INDUSTRY

Principal Investigators

  • Luigi Allegra, Ph.D. · Ospedale Maggiore di Milano IRCCS Policlinico

  • Francesco Blasi, MD · Ospedale Maggiore di Milano IRCCS Policlinico

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125644 on ClinicalTrials.gov