Condition
Candidemia and Invasive Candidiasis
Candidemia and invasive candidiasis are infections where Candida yeast, normally harmless on skin and in the gut, reaches the bloodstream and organs. The evidence is strong for anidulafungin, which achieved treatment success in 76% of people versus 60% with fluconazole, and for rezafungin, which matched caspofungin at day 14. Rezafungin showed similarity rather than an advantage, so it looks comparable, not better.
Sources: PMID 17576612; PMID 40651396
- Updated
- How we grade
- 100 studies cited
- Supplements studied
- 0
- Medicines and peptides
- 4
- Graded outcomes
- 17
Prescription medicines and peptides studied, for context
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| Efficacy by Candida Species Species subanalysis: Effective against C. albicans (42%), C. glabrata (26%), and C. tropicalis (20%). Consistent efficacy across major Candida species causing invasive disease. | Improves (the measure goes up) | Moderate effect | 39 studies | |||
Studies that measured efficacy by candida species
| ||||||
| Day-14 Global Cure ReSTORE Phase 3 (n=187): 59% rezafungin vs 61% caspofungin achieved global cure at day 14 (EMA primary endpoint). Noninferiority demonstrated. First new echinocandin approved in >10 years. | Improves (the measure goes up) | Moderate effect | 34 studies | |||
Studies that measured day-14 global cure
| ||||||
| 30-Day All-Cause Mortality ReSTORE Phase 3: 24% rezafungin vs 21% caspofungin mortality at day 30 (FDA primary endpoint). Noninferior within 20% margin. Similar safety profile to other echinocandins. | NoneNo effect | 34 studies | ||||
Studies that measured 30-day all-cause mortality
| ||||||
| Weekly Dosing Convenience Unique weekly dosing (vs daily for caspofungin/micafungin) enables outpatient parenteral therapy. May avoid need for central venous catheter. Improves patient convenience and reduces healthcare resource use. | Improves (the measure goes up) | Moderate effect | 34 studies | |||
Studies that measured weekly dosing convenience
| ||||||
Micafungin (Mycamine)
- HSCT Candida Prophylaxis: improves
- Invasive Candidiasis/Candidemia: improves
- Esophageal Candidiasis: improves
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| HSCT Candida Prophylaxis Phase 3 RCT: Micafungin superior to fluconazole for prophylaxis of invasive Candida infections in HSCT recipients. Only echinocandin FDA-approved for this indication. Significantly reduced breakthrough fungal infections. | Improves (the measure goes down) | Large effect | 19 studies | |||
| Invasive Candidiasis/Candidemia Phase 3 trials: Excellent clinical and microbiological efficacy in primary treatment of invasive candidiasis. Comparable to caspofungin and liposomal amphotericin B. FDA-approved for candidemia. | Improves (the measure goes up) | Moderate effect | 18 studies | |||
| Esophageal Candidiasis Clinical trials: Efficacy comparable to fluconazole in esophageal candidiasis treatment. FDA-approved indication. Endoscopic cure rates similar to standard therapy. | Improves (the measure goes up) | Moderate effect | 15 studies | |||
| Safety Profile (Pooled Analysis) Pooled analysis of 17 trials (n=3028): Favorable clinical safety profile similar to other echinocandins. Well tolerated across treatment and prophylaxis indications. Low discontinuation rates. | Improves (the measure goes up) | Large effect | 9 studies | |||
| Pediatric Efficacy Approved for pediatric use. Effective for prophylaxis and treatment in children including neonates. Weight-based dosing (2-4 mg/kg). Scientific evidence supports safety and efficacy in pediatric populations. | Improves (the measure goes up) | Moderate effect | 12 studies | |||
Anidulafungin
- Activity vs Fluconazole-Resistant Candida: improves
- Treatment Success (vs Fluconazole): improves
- Dose-Ranging Efficacy: improves
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| Activity vs Fluconazole-Resistant Candida In vitro: 99% of 315 fluconazole-resistant Candida isolates susceptible to anidulafungin (MIC <=1 μg/ml). Important option for azole-resistant infections. | Improves (the measure goes up) | Large effect | 16 studies | |||
Studies that measured activity vs fluconazole-resistant candida | ||||||
| Treatment Success (vs Fluconazole) Phase 3 RCT: 76% anidulafungin vs 60% fluconazole achieved treatment success (95% CI 4-27%, P=0.01). Superior efficacy in invasive candidiasis and candidemia. FDA approval 2006. | Improves (the measure goes up) | Moderate effect | 15 studies | |||
| Dose-Ranging Efficacy Phase 2 study (n=123): Success rates 84%, 90%, 89% at 50, 75, 100 mg respectively. High efficacy across dose range. 100 mg daily selected for Phase 3. | Improves (the measure goes up) | Large effect | 14 studies | |||
Studies that measured dose-ranging efficacy | ||||||
| Safety in Organ Impairment No dose adjustment needed in hepatic or renal impairment. Non-CYP450 metabolism minimizes drug interactions. Well tolerated with low discontinuation rates. | Improves (the measure goes up) | Moderate effect | 12 studies | |||
Key findings
- Efficacy by Candida SpeciesImproves (the measure goes up)
- Invasive Candidiasis EfficacyImproves (the measure goes up)
- Day-14 Global CureImproves (the measure goes up)
Safety notes in the studies
- No serious clinical or laboratory adverse events.
- May avoid need for central venous catheter.
Studies cited
100 studies from PubMed
- Echinocandins Pharmacokinetics: A Comprehensive Review of Micafungin, Caspofungin, Anidulafungin, and Rezafungin Population Pharmacokinetic Models and Dose Optimization in Special Populations.
- Efficacy and safety of voriconazole and caspofungin for the treatment of invasive pulmonary aspergillosis in critically ill patients in China.
- Rezafungin vs caspofungin for the treatment of invasive candidiasis: A systematic review and meta-analysis.
- Clinical and mycological outcomes of candidaemia and/or invasive candidiasis by Candida spp. and antifungal susceptibility: pooled analyses of two randomized trials of rezafungin versus caspofungin.
- Long-term Safety and Effectiveness of Rezafungin Treatment in Candidemia and Invasive Candidiasis: Results From an Early Access Program in Italy and Germany.
- Rezafungin: A Review in Invasive Candidiasis.
- Early use of the novel antifungal rezafungin: a case series and literature review.
- Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis: Results from the Double-blind, Randomized, Phase 3 ReSTORE Trial Including the China Extension Study.
- Initial micafungin treatment does not improve outcomes compared to fluconazole treatment in immunocompromised and critically ill patients with candidaemia.
- Plasma Concentration of Antifungal Agent Micafungin for Pediatric Living Donor Liver Transplantation.
- Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis
- Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults
- Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trials
- Formulary Drug Review: Rezafungin
- Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study
- New antifungals development: rezafungin in candidiasis treatment.
- A Mini-Review of In Vitro Data for Candida Species, Including C. auris, Isolated during Clinical Trials of Three New Antifungals: Fosmanogepix, Ibrexafungerp, and Rezafungin.
- Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials.
- Safety of rezafungin as a long-term treatment option in two patients with complicated fungal infections: two cases from Lecco Hospital (Italy).
- Pneumocystis jirovecii pneumonia in people living with HIV: a review.
- Formulary Drug Review: Rezafungin.
- Game Changer or More of the Same? A Comparative Meta-analysis of Rezafungin and Caspofungin in Treating Candidemia and Invasive Candidiasis.
- Efficacy of initial caspofungin plus trimethoprim/sulfamethoxazole for severe PCP in patients without human immunodeficiency virus infection.
- Micafungin: A promising inhibitor of UBE2M in cancer cell growth suppression.
- Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial
- An exciting time for antifungal therapy
- Rezafungin and invasive candida infections: a new game changing antifungal?
- Efficacy and safety of caspofungin for patients with hepatic insufficiency.
- Pharmacokinetics/Pharmacodynamics of Caspofungin in Plasma and Peritoneal Fluid of Liver Transplant Recipients.
- Risk assessment of micafungin-induced liver injury using spontaneous reporting system data and electronic medical records.
- Echinocandins - structure, mechanism of action and use in antifungal therapy.
- Evaluation of the Post-Antifungal Effect of Rezafungin and Micafungin against Candida albicans, Candida parapsilosis and Candida glabrata.
- A phase I randomized, double-blind, single subcutaneous dose escalation study to determine the safety, tolerability, and pharmacokinetics of rezafungin in healthy adult subjects.
- Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies.
- Caspofungin Effects on Electrocardiogram of Mice: An Evaluation of Cardiac Safety.
- Caspofungin combined with TMP/SMZ as a first-line therapy for moderate-to-severe PCP in patients with human immunodeficiency virus infection.
- Nebulized Micafungin Treatment for Scopulariopsis/Microascus Tracheobronchitis in Lung Transplant Recipients.
- Biological Properties and Analytical Methods for Micafungin: A Critical Review.
- Rezafungin: a novel antifungal for the treatment of invasive candidiasis.
- The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin.
- Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial.
- Erratum to: Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial.
- Anidulafungin liposome nanoparticles exhibit antifungal activity against planktonic and biofilm Candida albicans.
- Factors influencing caspofungin plasma concentrations in kidney transplant patients with high incidence of invasive fungal infections.
- Caspofungin: a review of its characteristics, activity, and use in intensive care units.
- Micafungin as antifungal prophylaxis in non-transplanted haemotological patients.
- Drug-Induced Liver Injury (DILI) With Micafungin: The Importance of Causality Assessment.
- Activity of a Long-Acting Echinocandin, Rezafungin, and Comparator Antifungal Agents Tested against Contemporary Invasive Fungal Isolates (SENTRY Program, 2016 to 2018).
- Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data.
- Anidulafungin Susceptibility Testing of Candida glabrata Isolates from Blood Cultures by the MALDI Biotyper Antibiotic (Antifungal) Susceptibility Test Rapid Assay.
- Caspofungin for primary antifungal prophylaxis after T-cell-replete haploidentical stem cell transplantation with post-transplant cyclophosphamide.
- Adsorption and caspofungin dosing during continuous renal replacement therapy.
- Effect of Caspofungin vs Fluconazole Prophylaxis on Invasive Fungal Disease Among Children and Young Adults With Acute Myeloid Leukemia: A Randomized Clinical Trial.
- Micafungin may be safely administered as outpatient parenteral antimicrobial therapy for chronic pulmonary aspergillosis.
- Immune neutropenia mediated by micafungin.
- Micafungin prophylaxis for acute leukemia patients undergoing induction chemotherapy.
- Micafungin-Induced Hypoglycemia in a Patient With Type 1 Diabetes: A Case Report and Review of Literature.
- Candida glabrata prosthetic joint infection, successfully treated with anidulafungin: A case report and review of the literature.
- Caspofungin dosage adjustments are not required for patients with Child-Pugh B or C cirrhosis.
- Rezafungin: First-in-Class Echinocandin for Invasive Candidiasis and Invasive Aspergillosis Prophylaxis
- Rezafungin (CD101), a next-generation echinocandin: A systematic literature review and assessment of possible place in therapy.
- Successful treatment with caspofungin of candiduria in a child with Wilms tumor; review of literature.
- Micafungin: prophylaxis and treatment in paediatric patients
- Efficacy and safety of caspofungin in children: systematic review and meta-analysis.
- Micafungin as primary antifungal prophylaxis in patients presenting with acute myeloid leukemia.
- Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial.
- Combination antifungal therapy for invasive aspergillosis: a randomized trial.
- Anidulafungin: advantage for the newcomer?
- Pharmacokinetics and safety of intravitreal caspofungin.
- Micafungin for Candida albicans pacemaker-associated endocarditis: a case report and review of the literature.
- Anidulafungin for the treatment of invasive candidiasis
- Caspofungin for prophylaxis and treatment of fungal infections in adolescents and adults: a meta-analysis of randomized controlled trials.
- Efficacy and safety of micafungin for invasive candida infections: a meta-analysis of randomized controlled trials.
- Micafungin: a review of its use in the prophylaxis and treatment of invasive Candida infections.
- Anidulafungin: an evidence-based review of its use in invasive fungal infections
- Pharmacology and metabolism of anidulafungin, caspofungin and micafungin in the treatment of invasive candidosis: review of the literature.
- Treatment and prophylaxis of invasive candidiasis with anidulafungin, caspofungin and micafungin:review of the literature.
- Treatment and prophylaxis of invasive candidiasis with anidulafungin, caspofungin and micafungin and its impact on use and costs: review of the literature.
- Efficacy and safety of caspofungin in obese patients.
- Caspofungin therapy in immunocompromised children and neonates.
- Micafungin - the newest echinocandin
- Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases
- Safety of micafungin in infants: insights into optimal dosing.
- Safety of micafungin in pediatric clinical trials.
- Nebulizer delivery of micafungin aerosols.
- Micafungin-induced thrombotic thrombocytopenic purpura: a case report and review of the literature.
- Treatment and prophylaxis of invasive candidiasis with anidulafungin, caspofungin and micafungin and its impact on use and costs--review of the literature
- Pharmacokinetics, antifungal activity and clinical efficacy of anidulafungin in the treatment of fungal infections.
- Micafungin: a brief review of pharmacology, safety, and antifungal efficacy in pediatric patients.
- Efficacy and safety of micafungin as an empirical antifungal agent for febrile neutropenic patients with hematological diseases.
- Pharmacology and antifungal properties of anidulafungin, a new echinocandin.
- Pharmacological properties of antifungal drugs with a focus on anidulafungin.
- Anidulafungin, a new echinocandin: effectiveness and tolerability.
- [In vitro antifungal activity of micafungin].
- Antifungal activity of micafungin in serum.
- Micafungin-induced immune hemolysis attacks.
- Micafungin: a review of its use in the prophylaxis and treatment of invasive Candida infections in pediatric patients.
- [In vitro antifungal activity of anidulafungin].
- [Anidulafungin: a new therapeutic approach in antifungal therapy. Pharmacology of anidulafungin].
- Micafungin for the prophylaxis and treatment of Candida infections