Cryptococcosis or Aspergillosis Infections Clinical Trial
Official title:
Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis. Open Label Phase III Clinical Study
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).
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e Respiratorie | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Proaparts srl |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the overall global clinical response | 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. | 28 days | No |
| Secondary | Evaluate the safety in the administration of SPK-843. | 28 days | Yes |