Evidence map›Paper›PMID 21911573›Full record

Trial reportAntimicrobial agents and chemotherapy2011

Phase II dose escalation study of caspofungin for invasive Aspergillosis.

O A Cornely, J J Vehreschild, M J G T Vehreschild, G Würthwein, D Arenz, S Schwartz, C P Heussel, G Silling, M Mahne, J Franklin and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00404092 (A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis), which is not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT00404092 phase2completednot on this map

A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis

TypeinterventionalSponsorUniversity of CologneRan2006 to 2009Enrolled46ConditionsInvasive AspergillosisArmscaspofungin
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Guideline
  2. 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 · 2016
    Guideline
  3. Guideline
  4. Low Caspofungin Exposure in Patients in Intensive Care Units.Antimicrobial agents and chemotherapy · 2017
    Trial
  5. Trial
  6. Trial
  7. Article
  8. Azole-ResistantJournal of fungi (Basel, Switzerland) · 2025
    Review
  9. Article
  10. Review
  11. ISCCM Position Statement on the Management of Invasive Fungal Infections in the Intensive Care Unit.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024
    Article
  12. Article
  13. Article
  14. Review
  15. Systemic Antifungal Therapy for Invasive Pulmonary Infections.Journal of fungi (Basel, Switzerland) · 2023
    Review
  16. Postantifungal Effect of Antifungal Drugs againstJournal of fungi (Basel, Switzerland) · 2022
    Review
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 1 country.

O A Cornely1st Department of Internal Medicine, University Hospital of Cologne, Kerpener Str 62, 50937 Cologne, Germany. oliver.cornely@ctuc.de
J J Vehreschild
M J G T Vehreschild
G Würthwein
D Arenz
S Schwartz
C P Heussel
G Silling
M Mahne
J Franklin
U Harnischmacher
A Wilkens
F Farowski
M Karthaus
T Lehrnbecher
A J Ullmann
M Hallek
A H Groll
University of Cologne · DEUniversity Hospital Münster · DECharité - Universitätsmedizin Berlin · DEHeidelberg University · DEJohannes Gutenberg University Mainz · DEMünchen Klinik Neuperlach · DEUniversity Hospital Frankfurt · DEUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our objective was to evaluate the maximum tolerated dose of caspofungin for invasive aspergillosis (IA). The safety and pharmacokinetics of escalating dosages of caspofungin were investigated in IA. Eight patients each received caspofungin 70, 100, 150, or 200 mg once a day (QD). Dose-limiting toxicity (DLT) was defined as the same non-hematological treatment-related adverse event of grade ≥ 4 in 2 of 8 patients or ≥ 3 in 4 of 8 patients in a cohort. A total of 46 patients (median age, 61 years; 21 female; 89% with hematological malignancies) received caspofungin (9, 8, 9, and 20 patients in the 70-, 100-, 150-, and 200-mg cohorts) for a median of 24.5 days. Plasma pharmacokinetics were linear across the investigated dosages and followed a two-compartment model, with weight as the covariate on clearance and sex as the covariate on central volume of distribution. Simulated peak plasma concentrations at steady state ranged from 14.2 to 40.6 mg/liter (28%), trough concentrations from 4.1 to 11.8 mg/liter (58%), and area under the concentration-time curve from 175 to 500 mg/liter/h (32%) (geometric mean, geometric coefficient of variation). Treatment was well tolerated without dose-limiting toxicity. The rate of complete or partial responses was 54.3%, and the overall mortality at 12-week follow-up was 28.3%. In first-line treatment of invasive aspergillosis, daily doses of up to 200 mg caspofungin were well tolerated and the maximum tolerated dose was not reached. Pharmacokinetics was linear. Response rates were similar to those previously reported for voriconazole and liposomal amphotericin.

Indexed as

Antifungal AgentsAspergillosisCaspofunginCohort StudiesDose-Response Relationship, DrugDrug Administration ScheduleEchinocandinsFemaleFollow-Up StudiesHumansLipopeptidesMaleMiddle AgedSurvival AnalysisTreatment OutcomeAntifungal AgentsCaspofunginEchinocandinsLipopeptides

Identifiers

PMID21911573
PMCPMC3232774
OpenAlexW2163773890

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.