Candidemia
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CLINICAL_TRIALS safety_alert · 2016-02-04Clinical Trial Update: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
A Pfizer-sponsored trial in invasive candidiasis evaluated the risk of severe hepatic injury with echinocandins. The study was terminated an…
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CLINICAL_TRIALS withdrawal · 2015-10-27Clinical Trial Update: UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients
A non-interventional observational trial (NCT01622595) evaluating infectious complications in cancer patients sponsored by the University of…
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CLINICAL_TRIALS trial_result · 2015-09-21Clinical Trial Update: A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis [Phase 3]
A Phase 3 randomized trial comparing anidulafungin to fluconazole for candidemia and invasive candidiasis was terminated; results were poste…
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FDA approval · 2015-09-02FDA Approved: VORICONAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's original application for a generic Voriconazole (ANDA 203503), enabling the generic antifungal to be marketed in…
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CLINICAL_TRIALS withdrawal · 2015-06-30Clinical Trial Update: A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia [Phase 1, Phase 2]
A Phase 1/2 study evaluating tolerability and early efficacy of hLF1-11 in proven candidemia was withdrawn.
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FDA approval · 2015-03-19FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Fluconazole from Hikma Pharmaceuticals USA Inc., updating the regulatory approval of this pr…
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CLINICAL_TRIALS trial_result · 2014-12-04Clinical Trial Update: Early- and Late-onset Candidemia
A clinical trial evaluating early- and late-onset candidemia has completed; the snippet provides sponsor information but no trial results.
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CLINICAL_TRIALS research · 2014-11-19Clinical Trial Update: SIHAM Candidemia Network:An Observational Study
An observational study of candidemia conducted by the SIHAM Candidemia Network; the study status is completed.
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FDA approval · 2014-10-23FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for CANCIDAS (caspofungin acetate) filed by Merck Sharp & Dohme LLC.
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CLINICAL_TRIALS trial_result · 2014-09-18Clinical Trial Update: Study of Micafungin in Patients With Invasive Candidiasis or Candidemia [Phase 3]
A Phase 3 study of micafungin for invasive candidiasis or candidemia has completed, representing a completed trial update for this antifunga…
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CLINICAL_TRIALS trial_result · 2014-09-18Clinical Trial Update: Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia [Phase 3]
Phase 3 trial comparing micafungin to liposomal amphotericin B (AmBisome) for invasive candidiasis and candidemia has completed.
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CLINICAL_TRIALS trial_result · 2014-08-20Clinical Trial Update: Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug [Phase 1]
A Phase 1 study evaluating the safety and drug blood levels of micafungin (Mycamine) in infants and toddlers with invasive candidiasis, esop…
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CLINICAL_TRIALS trial_result · 2014-07-16Clinical Trial Update: Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
A completed clinical trial examining outcomes in candidemia patients according to the in vitro susceptibility of Candida isolates.
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CLINICAL_TRIALS trial_result · 2014-06-09Clinical Trial Update: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
The DIRECT trial evaluating rapid detection of candidemia using the T2Candida panel by T2 Biosystems has completed.
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CLINICAL_TRIALS trial_result · 2014-05-26Clinical Trial Update: Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)
This is a completed clinical trial update for the direcT2 study evaluating rapid detection of candidemia by T2 Biosystems. The sponsor liste…
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FDA approval · 2014-04-07FDA Approved: VFEND — Supplemental Application (Roerig)
FDA approved a supplemental application for VFEND (voriconazole) submitted by Roerig.
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FDA approval · 2014-03-28FDA Approved: ERAXIS — Supplemental Application (Roerig)
FDA's supplemental application for ERAXIS (anidulafungin) submitted by Roerig is noted as a supplemental approval action. The entry shows th…
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FDA approval · 2014-03-24FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)
The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride, an intravenous formulation of fluconazole.
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CLINICAL_TRIALS trial_result · 2014-03-17Clinical Trial Update: Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal
This clinical trial update describes candidemia in a pediatric center and emphasizes that removing the central venous catheter is important …
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FDA approval · 2013-12-18FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC to update its labeling.
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CLINICAL_TRIALS research · 2013-04-23Clinical Trial Update: Prospective Population Study on Candidemia in Spain
A completed prospective population study on candidemia (fungemia) in Spain sponsored by Fundacion SEIMC-GESIDA.
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FDA approval · 2013-01-08FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC, authorizing changes to the drug's l…
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CLINICAL_TRIALS trial_result · 2012-12-20Clinical Trial Update: An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System [Phase 3]
A Phase 3 trial comparing anidulafungin to caspofungin for serious Candida infections in immunocompromised patients was terminated; results …
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CLINICAL_TRIALS trial_result · 2012-08-02Clinical Trial Update: Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants [NA]
A completed trial compared Veronate with placebo for preventing nosocomial Staphylococcal sepsis in premature infants, assessing safety and …
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FDA approval · 2012-03-14FDA Approved: FLUCONAZOLE — Supplemental Application (Hospira, Inc)
The FDA approved a supplemental application for fluconazole submitted by Hospira, Inc., authorizing changes to the product under the ANDA.