Trial reportAntimicrobial agents and chemotherapy2006
Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection.
Trial report in Antimicrobial agents and chemotherapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00034671 (Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole), which is not on this map. Cited by 75 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts
Who cites it
75 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Treatment of invasive fungal infections in cancer patients-updated recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO).Annals of hematology · 2014Guideline
- Antifungal pharmacodynamics: Latin America's perspective.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesPooled it
- Therapeutic drug monitoring of posaconazole in patients with acute myeloid leukemia or myelodysplastic syndrome.Antimicrobial agents and chemotherapy · 2012Trial
- Single-dose phase I study to evaluate the pharmacokinetics of posaconazole in new tablet and capsule formulations relative to oral suspension.Antimicrobial agents and chemotherapy · 2012Trial
- Pharmacokinetics of different dosing strategies of oral posaconazole in patients with compromised gastrointestinal function and who are at high risk for invasive fungal infection.Antimicrobial agents and chemotherapy · 2012Trial
- Relevance of timing for determination of posaconazole plasma concentrations.Antimicrobial agents and chemotherapy · 2011Trial
- Randomized comparison of safety and pharmacokinetics of caspofungin, liposomal amphotericin B, and the combination of both in allogeneic hematopoietic stem cell recipients.Antimicrobial agents and chemotherapy · 2010Trial
- Intracellular concentrations of posaconazole in different compartments of peripheral blood.Antimicrobial agents and chemotherapy · 2010Trial
- Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers.Antimicrobial agents and chemotherapy · 2009Trial
- Posaconazole Target Attainment in Critically Ill Children: A 15-Year Single-Center Retrospective Analysis.Clinical and translational science · 2026Article
- Commemorating the Landmark Advances in Our Understanding of Mucormycosis by Dimitrios P. Kontoyiannis.Journal of fungi (Basel, Switzerland) · 2025Article
- Diagnosis and management of invasive fungal infections due to non-Aspergillus moulds.The Journal of antimicrobial chemotherapy · 2025Review
- Efficacy and Safety Assessment of Antifungal Prophylaxis with Posaconazole Using Therapeutic Drug Monitoring in Pediatric Patients with Oncohematological Disorders-A Single-Centre Study.Journal of fungi (Basel, Switzerland) · 2025Article
- Challenges in the Treatment of Invasive Aspergillosis in Immunocompromised Children.Antimicrobial agents and chemotherapy · 2022Review
- The Role of New Posaconazole Formulations in the Treatment of Candida albicans Infections: Data from anAntimicrobial agents and chemotherapy · 2021Article
- Review
- Observational
- Clinical Pharmacokinetics of Second-Generation Triazoles for the Treatment of Invasive Aspergillosis and Candidiasis.European journal of drug metabolism and pharmacokinetics · 2019Review
- Clinical Pharmacokinetics and Dose Recommendations for Posaconazole in Infants and Children.Clinical pharmacokinetics · 2019Article
15 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmacokinetic profiles, safety, and efficacies of different dosing schedules of posaconazole oral suspension in patients with possible, probable, and proven refractory invasive fungal infection (rIFI) or febrile neutropenia (FN) were evaluated in a multicenter, open-label, parallel-group study. Sixty-six patients with FN and 32 patients with rIFI were randomly assigned to one of three posaconazole regimens: 200 mg four times a day (q.i.d.) for nine doses, followed by 400 mg twice a day (b.i.d.); 400 mg q.i.d. for nine doses, followed by 600 mg b.i.d.; or 800 mg b.i.d. for five doses, followed by 800 mg once a day (q.d.). Therapy was continued for up to 6 months in patients with rIFI or until neutrophil recovery occurred in patients with FN. The 400-mg-b.i.d. dose provided the highest overall mean exposure, with 135% (P = 0.0004) and 182% (P < 0.0001) greater exposure than the 600-mg-b.i.d. and 800-mg-q.d. doses, respectively. However, exposure in allogeneic bone marrow transplant (BMT) recipients (n = 12) was 52% lower than in non-BMT patients. Treatment-related adverse events (occurring in 24% of patients) were mostly gastrointestinal in nature. Twenty-four percent of patients had adverse events leading to premature discontinuation (none were treatment related). In efficacy-evaluable patients, successful clinical response was observed in 43% with rIFI (56% of patients receiving 400 mg b.i.d., 17% receiving 600 mg b.i.d., and 50% receiving 800 mg q.d.) and 77% with FN (74% receiving 400 mg b.i.d., 78% receiving 600 mg b.i.d., and 81% receiving 800 mg q.d.). Posaconazole is well tolerated and absorbed. Divided doses of 800 mg (400 mg b.i.d.) provide the greatest posaconazole exposure.
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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.