Cryptococcosis or Aspergillosis InfectionsPhase 3NCT01125644
Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis
A Phase 3 study testing SPK-843 in people with Cryptococcosis or Aspergillosis Infections, run by Proaparts srl at 1 site in Italy.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cryptococcosis or Aspergillosis Infections
- What is being tested?
- SPK-843
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- May 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore di Milano IRCCS Policlinico Dipartimento Malattie Cardiovascolari e Respiratorie
Milan, 20122
Luigi Allegra, Ph.D, 39 02 55033781, luigi.allegra@unimi.it
Francesco Blasi, MD
About this study
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).
Read the 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: 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
- Improvement on the basis of clinical symptoms;
- Antifungal efficacy from the cultures;
- Improvement on the basis of mycological blood testing;
- Improvement on the basis of laboratory diagnosis (hemogasanalysis, ESR, CPR);
- Improvement on the basis of radiological imaging (Rx, CAT HR,…);
- Improvement on the basis of endoscopic examination;
- Evaluate the plasma levels of SPK-843 after single dose and after multiple doses;
- Evaluate the safety in the administration of SPK-843.
Methodology: Open label multi center study
- Being tested
- SPK-843
- Keywords
- necrotic pulmonary infections
- Medical subject headings
- Cryptococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPK-843Drug
Also called SPA-S-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
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients are males and females between 18 and 75 years of age 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"). Receives: Drug: SPK-843 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Evaluate the safety in the administration of SPK-843.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptococcosis or Aspergillosis InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proaparts srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luigi Allegra, Ph.D., Study director, Ospedale Maggiore di Milano IRCCS PoliclinicoFrancesco Blasi, MD, Principal investigator, Ospedale Maggiore di Milano IRCCS Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125644
- Sponsor's protocol ID
- SPK-843-03/01
- Status last verified
- Jun 2011
- First submitted
- 17 May 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis. Open Label Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT01125644
- Acronym / sponsor ID
- SPK-843-03/01
- Keywords
- necrotic pulmonary infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Proaparts srlIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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: 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
- Improvement on the basis of clinical symptoms;
- Antifungal efficacy from the cultures;
- Improvement on the basis of mycological blood testing;
- Improvement on the basis of laboratory diagnosis (hemogasanalysis, ESR, CPR);
- Improvement on the basis of radiological imaging (Rx, CAT HR,…);
- Improvement on the basis of endoscopic examination;
- Evaluate the plasma levels of SPK-843 after single dose and after multiple doses;
- Evaluate the safety in the administration of SPK-843.
Methodology: Open label multi center study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: SPK-843Patients are males and females between 18 and 75 years of age 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"). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPK-843Also: SPA-S-843SPK-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 | Drug | Single Arm |
Primary outcome
Evaluation of the overall global clinical response
Time frame: 28 days
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.
1 secondary outcome
Evaluate the safety in the administration of SPK-843.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Allegra, Ph.D. study director
Ospedale Maggiore di Milano IRCCS Policlinico
Francesco Blasi, MD principal investigator
Ospedale Maggiore di Milano IRCCS Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPK-843 in people with Cryptococcosis or Aspergillosis Infections, run by Proaparts srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Allegra, Ph.D (39 02 55033781, luigi.allegra@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the overall global clinical response (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.