Trial reportAntimicrobial agents and chemotherapy2015
Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study.
Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00413439 (Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia), which is not on this map. Cited by 50 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
Who cites it
50 citing papers in PubMed, 2 syntheses or guidelines pooled it, 112 citations in OpenAlex.
- Updated antimicrobial dosing recommendations for obese patients.Antimicrobial agents and chemotherapy · 2024Pooled it
- Guideline
- A phase 2, randomized, double-blind, multicenter trial to evaluate the safety and efficacy of three dosing regimens of isavuconazole compared with fluconazole in patients with uncomplicated esophageal candidiasis.Antimicrobial agents and chemotherapy · 2015Trial
- The Activity of FDA-Approved Prodrug Isavuconazonium Sulfate and Its Major Metabolite Isavuconazole AgainstPharmaceutics · 2026Article
- Prospective study of pharmacokinetics of isavuconazole in critically ill patients undergoing continuous hemodialysis with and without acute-on-chronic liver failure.Annals of intensive care · 2026Article
- Exploratory model-based optimizing isavuconazole dosing regimens forFrontiers in cellular and infection microbiology · 2026Article
- Isavuconazole in Pediatric Invasive Fungal Infections: Outcomes and Therapeutic Drug Monitoring in a Chinese Multicenter Case Series.Infection and drug resistance · 2026Article
- Incidence of Breakthrough Fungal Infections in Patients With Isavuconazole Prophylaxis: A Systematic Review and Meta-analysis.Open forum infectious diseases · 2025Article
- Unexpected renal influence on isavuconazole trough concentrations: two case reports and literature review.Frontiers in medicine · 2025Article
- Isavuconazole as prophylaxis and therapy for invasive fungal diseases: a real-life observational study.The Journal of antimicrobial chemotherapy · 2024Observational
- Pharmacokinetics of isavuconazole at different target sites in healthy volunteers after single and multiple intravenous infusions.The Journal of antimicrobial chemotherapy · 2024Article
- Primary prophylaxis of invasive fungal diseases in patients with haematological malignancies: 2022 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO).The Journal of antimicrobial chemotherapy · 2023Review
- Clinical Features and Treatment Progress of Invasive Mucormycosis in Patients with Hematological Malignancies.Journal of fungi (Basel, Switzerland) · 2023Review
- A physiologically based pharmacokinetic analysis to predict the pharmacokinetics of intravenous isavuconazole in patients with or without hepatic impairment.Antimicrobial agents and chemotherapy · 2023Article
- Salvage Treatment for Invasive Aspergillosis and Mucormycosis: Challenges, Recommendations and Future Considerations.Infection and drug resistance · 2023Review
- New Perspectives on Antimicrobial Agents: Isavuconazole.Antimicrobial agents and chemotherapy · 2022Review
- Challenges in the Treatment of Invasive Aspergillosis in Immunocompromised Children.Antimicrobial agents and chemotherapy · 2022Review
- Isavuconazole for COVID-19-Associated Invasive Mold Infections.Journal of fungi (Basel, Switzerland) · 2022Review
- Interaction of Antifungal Drugs with CYP3A- and OATP1B-Mediated Venetoclax Elimination.Pharmaceutics · 2022Article
- Therapeutic Drug Monitoring of Isavuconazole: Serum Concentration Variability and Success Rates for Reaching Target in Comparison with Voriconazole.Antibiotics (Basel, Switzerland) · 2021Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Isavuconazole is a novel broad-spectrum triazole antifungal agent. This open-label dose escalation study assessed the safety and pharmacokinetics of intravenous isavuconazole prophylaxis in patients with acute myeloid leukemia who had undergone chemotherapy and had preexisting/expected neutropenia. Twenty-four patients were enrolled, and 20 patients completed the study. The patients in the low-dose cohort (n = 11) received isavuconazole loading doses on day 1 (400/200/200 mg, 6 h apart) and day 2 (200/200 mg, 12 h apart), followed by once-daily maintenance dosing (200 mg) on days 3 to 28. The loading and maintenance doses were doubled in the high-dose cohort (n = 12). The mean ± standard deviation plasma isavuconazole areas under the concentration-time curves for the dosing period on day 7 were 60.1 ± 22.3 μg · h/ml and 113.1 ± 19.6 μg · h/ml for the patients in the low-dose and high-dose cohorts, respectively. The adverse events in five patients in the low-dose cohort and in eight patients in the high-dose cohort were considered to be drug related. Most were mild to moderate in severity, and the most common adverse events were headache and rash (n = 3 each). One patient in the high-dose cohort experienced a serious adverse event (unrelated to isavuconazole treatment), and two patients each in the low-dose and high-dose cohorts discontinued the study due to adverse events. Of the 20 patients who completed the study, 18 were classified as a treatment success. In summary, the results of this analysis support the safety and tolerability of isavuconazole administered at 200 mg and 400 mg once-daily as prophylaxis in immunosuppressed patients at high risk of fungal infections. (This study is registered at ClinicalTrials.gov under registration number NCT00413439.).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.