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Label indication CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients. ( 1 ) Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. ( 1 ) Treatment of esophageal candidiasis. FDA label
Also known as caspofungin acetate, MK-0991, CANCIDAS®
caspofungin · 9 trials · 8 indications
A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.
A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention. A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.
Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.
Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.
| Arm | Type | Description |
|---|---|---|
| Caspofungin | EXPERIMENTAL | caspofungin acetate (MK0991) |
| Micafungin | ACTIVE_COMPARATOR | Micafungin sodium |
| Caspofungin 50 mg Intravenous (IV) | EXPERIMENTAL | - |
| 1 | ACTIVE_COMPARATOR | 50 mg intravenous (IV) infusion (diluted with 9% saline) administered daily (following a 70-mg IV loading dose on Day 1), over the course of \~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection. |
| 2 | EXPERIMENTAL | 150 mg intravenous (IV) infusion (diluted with 9% saline) administered daily, over the course of \~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection. |
| Participants with Esophageal Candidiasis | EXPERIMENTAL | Candida infection is strongly suspected based on clinical symptoms and the participant's clinical course, white moss (plaque) is observed on the esophageal mucosa, and therapy via intravenous infusion is judged to be suitable for the present episode of esophageal candidiasis. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively. |
| Participants with Invasive Candidiasis | EXPERIMENTAL | Candida infection is strongly suspected based on the presence of refractory fever not responding to an antibiotic agent, or clinical symptoms at the site of disease, or the participant's clinical course. In addition, at least 1 of the following criteria must be met: 1) Candida infection is strongly suspected based on radiographic imaging findings and positive serological test for fungus, 2) yeast is observed by direct microscopy or histopathological test of tissue biopsied from the site of disease, or 3) Candida species are observed by culture test of specimens sampled from the site of disease. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively. |
| Participants with Aspergillosis | EXPERIMENTAL | Aspergillus infection is strongly suspected based on clinical symptoms and the participant's clinical course, and characteristic radiographic imaging findings are observed. In addition, at least 1 of the following criteria must be met: 1) risk factors predisposing to an Aspergillus infection, 2) positive serological test for Aspergillus, 3) acute-branching mold with separated hyphae are observed by direct microscopy or histopathological test, or 4) Aspergillus species are observed by culture test. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively. |
| Name | Type | Description |
|---|---|---|
| caspofungin acetate | DRUG | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Comparator: Micafungin sodium | DRUG | Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Caspofungin | DRUG | - |
| Comparator: AmBisome | DRUG | Duration of Treatment: 28-90 days |
Inclusion Criteria: * Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp. Exclusion Criteria: * Patients With Mycoses Other Than Ones Due To...
Top 1 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Posaconazole |
Caspofungin is used to treat fungal infections, including aspergillosis, esophageal candidiasis, invasive candidiasis, and fungal infections in patients with neutropenia. It is an antifungal medicine studied in adults and in Japanese children and adolescents with documented Candida or Aspergillus infections.
Caspofungin is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is the sponsor behind the clinical studies of caspofungin, including the trials conducted in Japanese, Chinese, and Indian patient populations.
Caspofungin has been studied across Phase 2 and Phase 3 clinical development. Its four listed trials are all completed, with no active trials currently ongoing. The studies enrolled a combined total of 250 participants and covered indications such as candidiasis, aspergillosis, and fungal infection.
Caspofungin has been evaluated in four completed trials: NCT01165320 in Japanese children and adolescents with Candida or Aspergillus infections, NCT00717860 in Japanese patients with deep-seated infections, NCT00635648 in Chinese adults with esophageal or invasive candidiasis, and NCT00379964 in Indian adults with persistent fever and neutropenia.
Yes, caspofungin acetate is another name for caspofungin. The two names refer to the same antifungal medicine, and caspofungin acetate appears in the title of the trial NCT00635648, which studied it for esophageal candidiasis or invasive candidiasis in Chinese adults.
Caspofungin has been studied as empirical therapy in adults with persistent fever and neutropenia. Trial NCT00379964 evaluated the safety, tolerability, and efficacy of caspofungin injection over 28 to 90 days in Indian adults with persistent fever and neutropenia.