Fungal InfectionPhase 2CASPHYLAXNCT01318148
Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis
A Phase 2 study testing caspofungin in people with Fungal Infection, run by Werner J. Heinz at 1 site in Germany.
Trial summary
The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection
- What is being tested?
- caspofungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Oct 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia
- receiving induction chemotherapy
Who cannot join
- current or need of systemic antifungal therapy
- history of proven or probable invasive aspergillus infection
- pregnant or breastfeeding women
- weight more than 100 kg
- history of allergy, hypersensitivity or any serious reaction to caspofungin
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Wuerzburg Medical Centre, Department of Internal Medicine II
Würzburg, 97080
About this study
Official title: Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients
The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.
Read the detailed description
Pharmacokinetic and safety of caspofungin, in an intermittent dosing schedule, for prophylaxis of invasive fungal (IFI) infections will be evaluated in patients receiving induction chemotherapy for treatment of acute myeloid leukemia, myelodysplastic syndrome with blast crisis or acute lymphatic leukemia.
For prophylaxis caspofungin once daily will be given three times a week after a loading phase of three days. For drug monitoring serum samples will be collected from the first day of trial medication till one day after end of therapy (EOT). Invasive fungal infections will be diagnosed analog the criteria defined by the European organization for Research and Treatment of Cancer and the Mycosis Study Group (EORTC/MSG), revised in 2008.
Caspofungin prophylaxis will be stopped after the end of neutropenia, in case of documented proven or probable invasive fungal disease and in case of a serious adverse event attributable to the study drug, for which in view of the investigator further usage of the study drug should be avoided.
- Conditions
- Fungal Infection
- Being tested
- caspofungin
- Keywords
- Echinocandins, Caspofungin, Pharmacokinetics, Prophylaxis, Antifungal, Aspergillosis, Acute Leucemia
- Medical subject headings
- Mycoses, Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofunginDrug
Also called Cancidas
Intermittent intravenous application of caspofungin
| Study group | Role | What they receive |
|---|---|---|
| Caspofungin | Experimental | Not described Receives: Drug: caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
caspofungin pharmacokinetic
To characterize the pharmacokinetic of caspofungin IV solution in an intermittent dosing schedule of 3 times a week after a 3 days loading in a representative subject population.
Measured: day 20 (average), till end of enutropenia
Secondary outcomes (3)
Caspofungin pharmacokinetic
caspofungin serum concentrations
Measured: day 20 (average), at end of neutropenia
Incidence of invasive fungal disease and outcome
Incidence of proven or probable invasive fungal disease according to the revised EORTC/MSG criteria during the period of prophylaxis and during follow up.
Measured: day 100 after start of chemotherapy
Safety of intermittent caspofungin
Caspofungin related and all adverse and serious adverse events
Measured: day 34 (average), 2 weeks after end of neutropenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Werner J. Heinz
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Werner J. Heinz, Wuerzburg University Hospital
- Investigators
- Werner J Heinz, MD, Study chair, University of Wuerzburg Medical Centre, Department of Internal Medicine II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318148
- Sponsor's protocol ID
- UKW-Inf-001
- Other IDs
- 2009-015159-26, 2009
- Acronym
- CASPHYLAX
- Status last verified
- Jan 2014
- First submitted
- 17 Mar 2011
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients
- ClinicalTrials.gov ID
- NCT01318148
- Acronym / sponsor ID
- CASPHYLAX / UKW-Inf-001
- Conditions
- Fungal Infection
- Keywords
- Echinocandins, Caspofungin, Pharmacokinetics, Prophylaxis, Antifungal, Aspergillosis, Acute Leucemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Werner J. HeinzUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Mar 2011 (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.
The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.
Detailed description
Pharmacokinetic and safety of caspofungin, in an intermittent dosing schedule, for prophylaxis of invasive fungal (IFI) infections will be evaluated in patients receiving induction chemotherapy for treatment of acute myeloid leukemia, myelodysplastic syndrome with blast crisis or acute lymphatic leukemia.
For prophylaxis caspofungin once daily will be given three times a week after a loading phase of three days. For drug monitoring serum samples will be collected from the first day of trial medication till one day after end of therapy (EOT). Invasive fungal infections will be diagnosed analog the criteria defined by the European organization for Research and Treatment of Cancer and the Mycosis Study Group (EORTC/MSG), revised in 2008.
Caspofungin prophylaxis will be stopped after the end of neutropenia, in case of documented proven or probable invasive fungal disease and in case of a serious adverse event attributable to the study drug, for which in view of the investigator further usage of the study drug should be avoided.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caspofungin | Experimental | Drug: caspofungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia
- receiving induction chemotherapy
Key exclusion criteria (5 listed)
- current or need of systemic antifungal therapy
- history of proven or probable invasive aspergillus infection
- pregnant or breastfeeding women
- weight more than 100 kg
- history of allergy, hypersensitivity or any serious reaction to caspofungin
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 |
|---|---|---|
| caspofunginAlso: CancidasIntermittent intravenous application of caspofungin | Drug | Caspofungin |
Primary outcome
caspofungin pharmacokinetic
Time frame: day 20 (average), till end of enutropenia
To characterize the pharmacokinetic of caspofungin IV solution in an intermittent dosing schedule of 3 times a week after a 3 days loading in a representative subject population.
3 secondary outcomes
Caspofungin pharmacokinetic
Time frame: day 20 (average), at end of neutropenia
Incidence of invasive fungal disease and outcome
Time frame: day 100 after start of chemotherapy
Safety of intermittent caspofungin
Time frame: day 34 (average), 2 weeks after end of neutropenia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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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.
Werner J Heinz, MD study chair
University of Wuerzburg Medical Centre, Department of Internal Medicine II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing caspofungin in people with Fungal Infection, run by Werner J. Heinz at 1 site in Germany.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jan 2014. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caspofungin pharmacokinetic (time frame: day 20 (average), till end of enutropenia). 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 9 Jan 2014.