CandidemiaPhase 4NCT00839540
Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins
A Phase 4 study testing micafungin and Caspofungin in people with Candidemia, run by Gary E. Stein, Pharm.D. at 1 site in United States.
Trial summary
The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is: To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- What is being tested?
- micafungin and Caspofungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients with presumptive candidemia
Who cannot join
- Patients with severe neutropenia (<500)
- Patients with APACHE II scores > 20
- Patients with severe liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins in Patients With Presumptive Candidemia
The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:
To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities.
This investigation will provide clinicians information supporting the use of caspofungin and micafungin in situations where Candida strains may be a cause of infection.
Read the detailed description
Methods:
Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia (<500) APACHE II scores > 20, or significant liver disease will be excluded. All will give written informed consent (Pappas et al. CID. Oct 1, 2007).
Drugs - Patients will receive either CFG: 70 mg loading dose (LD) followed by 50 mg once daily (qd) (8 patients), MFG: 100 mg qd (8 patients) or MFG: 200 mg qd (8 patients). All agents will be given by slow IV infusion (MFG will be supplied by Astellas).
Sera - Blood samples will be collected at the end of the infusion (peak) and at 12 h and 24 h (trough) after the beginning of an infusion (day 3-4).
Each patients sera will be tested (MIC and cidal activity) against their own Candida isolate (if isolated). In addition, recent clinical isolates of C. glabrata will also be tested against patient sera (time-kill) to verify previous in vitro and animal PD studies (Cota. AAC. Nov. 2006; Wiederhold. AAC. May 2007).
Results:
- Patient outcome, including Candida eradication, will be documented for each patient by repeat culture.
- Serum concentrations (lab to be determined) and PK analysis of each echinocandin will be determined for each patient.
- Serum cidal titers will be measured against each of the Candida isolates for each agent at each time period. Median and geometric mean Peak and duration of cidal activity will then be determined and compared.
- Conditions
- Candidemia
- Being tested
- micafungin, Caspofungin
- Keywords
- candidemia, echinocandin, micafungin, caspofungin
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micafunginDrug
Also called Micamine
100 mg qd by slow IV infusion for 24 h
MicafunginDrug
Also called Micamine
200 mg qd by slow IV infusion for 24 h
CaspofunginDrug
Also called Cancidas
70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
| Study group | Role | What they receive |
|---|---|---|
| micafungin 100 | Active comparator | Patients receive Micafungin 100 mg qd Receives: Drug: micafungin |
| micafungin 200 | Active comparator | Patients receive 200 mg Micafungin qd Receives: Drug: Micafungin |
| Caspofungin | Active comparator | Patients receive caspofungin 70 mg LD followed by 50 mg qd Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).
These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M).
Measured: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CandidemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary E. Stein, Pharm.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor-investigator, Gary E. Stein, Pharm.D., Michigan State University
- Investigators
- Gary E Stein, Pharm.D., Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839540
- Sponsor's protocol ID
- PA-07-004
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2009
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins in Patients With Presumptive Candidemia
- ClinicalTrials.gov ID
- NCT00839540
- Acronym / sponsor ID
- PA-07-004
- Conditions
- Candidemia
- Keywords
- candidemia, echinocandin, micafungin, caspofungin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gary E. Stein, Pharm.D.University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Dec 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:
To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities.
This investigation will provide clinicians information supporting the use of caspofungin and micafungin in situations where Candida strains may be a cause of infection.
Detailed description
Methods:
Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia (<500) APACHE II scores > 20, or significant liver disease will be excluded. All will give written informed consent (Pappas et al. CID. Oct 1, 2007).
Drugs - Patients will receive either CFG: 70 mg loading dose (LD) followed by 50 mg once daily (qd) (8 patients), MFG: 100 mg qd (8 patients) or MFG: 200 mg qd (8 patients). All agents will be given by slow IV infusion (MFG will be supplied by Astellas).
Sera - Blood samples will be collected at the end of the infusion (peak) and at 12 h and 24 h (trough) after the beginning of an infusion (day 3-4).
Each patients sera will be tested (MIC and cidal activity) against their own Candida isolate (if isolated). In addition, recent clinical isolates of C. glabrata will also be tested against patient sera (time-kill) to verify previous in vitro and animal PD studies (Cota. AAC. Nov. 2006; Wiederhold. AAC. May 2007).
Results:
- Patient outcome, including Candida eradication, will be documented for each patient by repeat culture.
- Serum concentrations (lab to be determined) and PK analysis of each echinocandin will be determined for each patient.
- Serum cidal titers will be measured against each of the Candida isolates for each agent at each time period. Median and geometric mean Peak and duration of cidal activity will then be determined and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| micafungin 100 | Active comparator | Drug: micafunginPatients receive Micafungin 100 mg qd |
| micafungin 200 | Active comparator | Drug: MicafunginPatients receive 200 mg Micafungin qd |
| Caspofungin | Active comparator | Drug: CaspofunginPatients receive caspofungin 70 mg LD followed by 50 mg qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with presumptive candidemia
Key exclusion criteria (3 listed)
- Patients with severe neutropenia (<500)
- Patients with APACHE II scores > 20
- Patients with severe liver disease
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 |
|---|---|---|
| micafunginAlso: Micamine100 mg qd by slow IV infusion for 24 h | Drug | micafungin 100 |
| MicafunginAlso: Micamine200 mg qd by slow IV infusion for 24 h | Drug | micafungin 200 |
| CaspofunginAlso: Cancidas70 mg LD followed by 50 mg qd by slow IV infusion for 24 h | Drug | Caspofungin |
Primary outcome
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Time frame: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Candidemia
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Candidemia
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.
Gary E Stein, Pharm.D. principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing micafungin and Caspofungin in people with Candidemia, run by Gary E. Stein, Pharm.D. at 1 site in United States.
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 1 inclusion and 3 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 30 Apr 2024. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) (time frame: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug). 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 30 Apr 2024.