pulmonary mycosis(cryptococcosis o aspergillosis) MedDRA version: 9.1 Level: LLT Classification code 10037371 MedDRA version: 9.1 Level: LLT Classification code 10059259 MedDRA version: 9.1 Level: LLT Classification code 10027833
Conditions
Interventions
Product Code: SPK-843
Pharmaceutical Form: Powder for infusion*
Current Sponsor code: SPK-843
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
PRO APARTS SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with fungal etiology demonstrated by an examination of micologic culture (crop) and histopathological examination (patients with definite diagnosis), or patients with fungal infection which is difficult to determine the causative agent but with a diagnosis of deep mycosis based on serological test for fungal infection and / or clinical radiological investigation, and / or clinical endoscopic investigation, clinical symptoms (patients with clinical diagnosis). Patients treated with other antifungal drugs with a poor response to treatment after at least 5 days of administration of the antifungal drug, which had an adverse drug reaction that affects the use, considering the risk / benefit profile for the patient. Age between 18 and 75 years. Subjects are able to understand what is written in the form of informed consent and eager to participate in the trial. Male and female. Patients admitted to the hospital identified for the trial in question. Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with clinical improvement of symptoms or a clinical course not clear, being treated with other antifungal drugs; patients with intravenous catheter and hospitalized with a diagnosis of fungemia, without clinical symptoms in 12 hours after removal of the catheter; patients with severe deep mycosis with a low probability of clinical efficacy (probability of occurrence with very high death), or severe concomitant diseases or complications that can lead to difficulties in assessing the safety in the treatment in question; Patients with a history of allergy to drugs such as AMPH-B or severe allergic reactions to drugs (shock after administration of several drugs by antifungals); patients with severe hepatic insufficiency, renal, cardiac or pulmonary disease or with the basic function test of body meeting the following criteria: - AST (GOT) or ALT (GPT) greater than 5 times the upper limit of normal or 200 IU / L; - Serum creatinine greater than 2.0 mg / dl; - Proteinuria (qualitative test) 3 + or higher, or total urinary excretion of protein (quantitative test) of 3.5 g / day or higher; - Hyperkalemia or hypokalemia, or baseline level of sodium of 6.0 mEq / L or greater or less than 2.5 mEq / L; - Hyperlipidaemia with a baseline total cholesterol greater than 1.5 times the upper limit of normal or 300 mg / dl, triglycerides greater than 2 times the upper limit of normal or 300 mg / dl; Patients who require an infusion of leukocytes; patients with arterial thrombosis or coagulation with severe dysfunction; patients with diabetes mellitus associated with ketosis; Women who are pregnant or wish to become pregnant, women in puerperium,breastfeeding women; Patients who have participated in a clinical study (with any kind of drugs including anticancer drugs) or who were enrolled for clinical observational studies with pharmaceutical agents in the previous month before the start of treatment with SPK-843; Patients who were not judged by the investigator to be eligible enrolled in the study in question.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of clinical response based on the total global secondary end points 1 to 6 at the end of treatment (Study Day 14) and the final study visit - follow up - (Study Day 28), compared to the initial clinical status. The assessment will be based on improvement / normalization on a semi-quantitative scale to 3.4 and 5 items or assessed as positive for at least 3 of the first 6 secondary end points;Secondary Objective: Improvement on the basis of clinical symptoms. Effectiveness antifungal crop. Improvement on the basis of serology mycology. Improvement on the basis of the diagnostic laboratory (emogasanalisi, VES, CPR) Improvement on radiological imaging (X-ray, CT HR). Improvement on the basis of endoscopic. To assess the plasma levels of SPK-843 after a single dose and after multiple doses. Assessing security in the administration of SPK-843.;Primary end point(s): Assessment of clinical response based on the total global secondary end points 1 to 6 at the end of treatment (Study Day 14) and the final study visit - follow up - (Study Day 28), compared to the initial clinical status. The assessment will be based on improvement / normalization on a semi-quantitative scale to 3.4 and 5 items or assessed as positive for at least 3 of the first 6 secondary end points | — |
Countries
Italy
Outcome results
None listed