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Efficacy of micafungin in patients with deep, invasive Candida infections

Abstract number: 1733_479

Ullmann A.J., De Waele J., Betts R., Rotstein C., Nucci M., Kovanda L., Wu C., Buell D., Diekmann H., Koblinger S., Cornely O.A.

Objectives: The objective of this study was a post hoc analysis of efficacy data from two double-blind, randomised, phase III trials with the echinocandin micafungin (MICA) in patients with invasive candidiasis (IC).

Methods: We reviewed data on patients with a baseline diagnosis of IC other than candidaemia enrolled in two double-blind, randomised, phase III MICA trials. A three-arm trial compared intravenous MICA 100 mg/day (MICA100) or 150 mg/day (MICA150) with intravenous caspofungin (CAS) (70 mg/day loading followed by 50 mg/day). A two-arm trial compared MICA100 with liposomal amphotericin B (L-AmB) 3 mg/kg/day. The studies shared similar endpoints: the primary efficacy endpoint was treatment success at the end of therapy, defined as both clinical and mycological response as assessed by the investigator. In this analysis, we reviewed data from the modified full analysis set (mFAS) for each of the trials, which for the three-arm trial included all randomised patients who received at least one dose of study drug and had documented Candida infection at baseline, confirmed by the data review panel. In this trial, the mFAS excluded patients with Candida-associated endocarditis, osteomyelitis or meningitis. For the two-arm trial, the mFAS included all patients who received at least one dose of study drug and had a confirmed diagnosis of IC or candidaemia.

Results: IC was observed in 85 of 578 patients (14.7%) in the three-arm trial and in 84 of 494 patients (17.0%) in the two-arm trial. Treatment success rates by infection site are shown in the table. MICA150 disseminated results were influenced by APACHE scores (2, 13, 14 for successes vs 12, 13, 16, 21, 23, 26, 29, 33 for failures). Otherwise, MICA was at least as effective as CAS in the three-arm trial in IC patients and not affected by the site of infection. In the two-arm trial, MICA was at least as effective as L-AmB in IC patients, and showed consistent efficacy independent of the infection site.

Infection siteTreatment success (%)
Three-arm trialTwo-arm trialPooled data on MICA 100
MICA100 (n = 199)MICA150 (n = 191)CAS (n = 188)MICA100 (n = 247)L-AmB (n = 247 
Invasive candidiasis22/28 (78.6)16/30 (53.3)17/26 (65.4)28/40 (70.0)22/38 (57.9)50/68 (73.5)
  Abscess5/5 (100)5/6 (83.3)6/9 (66.7)5/5 (100)4/6 (66.7)10/10 (100)
  Bone1/1 (100)
  Chorioretinitis0/21/1 (100)0/2
  Disseminated6/8 (75.0)3/11 (27.3)5/8 (62.5)7/10 (70.0)6/10 (60.0)13/18 (72.2)
  Endocardium–1/2 (50.0)3/5 (60.0)12 (50.0)  
  Endophthalmitis4/4 (100)1/3 (33.3)1/1 (100)4/4 (100)
  Kidney0/1
  Organ–1/1 (100) 
  Other3/3 (100)1/1 (100)3/3 (100)1/3 (33.3)0/14/6 (66.7)
  Peritonitis4/6 (66.7)4/7 (57.1)2/5 (40.0)14/20 (70.0)8/14 (57.1)18/26 (69.2)

Conclusion: In these trials, MICA was associated with efficacy comparable to both CAS and L-AmB in patients with IC and thus represents a valuable treatment option.

Session Details

Date: 31/03/2007
Time: 00:00-00:00
Session name: European Society of Clinical Microbiology and Infectious Diseases
Subject:
Location: ICC, Munich, Germany
Presentation type:
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