Clinical trial
Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins in Patients With Presumptive Candidemia
Name
PA-07-004
Description
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.
Trial arms
Trial start
2008-12-01
Estimated PCD
2010-05-01
Trial end
2010-05-01
Status
Completed
Phase
Early phase I
Treatment
micafungin
100 mg qd by slow IV infusion for 24 h
Arms:
micafungin 100
Other names:
Micamine
Micafungin
200 mg qd by slow IV infusion for 24 h
Arms:
micafungin 200
Other names:
Micamine
Caspofungin
70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
Arms:
Caspofungin
Other names:
Cancidas
Size
21
Primary endpoint
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
Eligibility criteria
Inclusion Criteria:
* Adult patients with presumptive candidemia
Exclusion Criteria:
* Patients with severe neutropenia (\<500)
* Patients with APACHE II scores \> 20
* Patients with severe liver disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}
Updated at
2024-04-30
1 organization
3 products
1 indication
Organization
Gary E. SteinProduct
micafunginIndication
CandidemiaProduct
MicafunginProduct
Caspofungin