Evidence map›Paper›PMID 20660670›Full record

Trial reportAntimicrobial agents and chemotherapy2010

Randomized comparison of safety and pharmacokinetics of caspofungin, liposomal amphotericin B, and the combination of both in allogeneic hematopoietic stem cell recipients.

Andreas H Groll, Gerda Silling, Charlotte Young, Rainer Schwerdtfeger, Helmut Ostermann, Werner J Heinz, Joachim Gerss, Hedwig Kolve, Claudia Lanvers-Kaminsky, João Paulo Vieira Pinheiro and 3 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Low Caspofungin Exposure in Patients in Intensive Care Units.Antimicrobial agents and chemotherapy · 2017
    Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Antimicrobial agents and chemotherapy · 2019
    Article
  9. Clinical Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Liposomal Amphotericin B.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Review
  10. Article
  11. Invasive Aspergillosis in Children: Update on Current Guidelines.Mediterranean journal of hematology and infectious diseases · 2018
    Review
  12. Tolerability and outcome of once weekly liposomal amphotericin B for the prevention of invasive fungal infections in hematopoietic stem cell transplant patients with graft-versus-host disease.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2016
    Article
  13. Article
  14. Review
  15. 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

13 authors at 6 institutions in 3 countries.

Andreas H GrollInfectious Disease Research Program, Center for Bone Marrow Transplantation and Department of Pediatric Hematology/Oncology, University Children’s Hospital Muenster, Muenster, Germany. grollan@ukmuenster.de
Gerda Silling
Charlotte Young
Rainer Schwerdtfeger
Helmut Ostermann
Werner J Heinz
Joachim Gerss
Hedwig Kolve
Claudia Lanvers-Kaminsky
João Paulo Vieira Pinheiro
Sibylle Gammelin
Oliver A Cornely
Gudrun Wuerthwein
University Hospital Münster · DEChildren's Clinical University Hospital · LVBielefeld University · DEDeutsche Klinik für Diagnostik · DEUniversitätsklinikum Würzburg · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The combination of liposomal amphotericin B (LAMB) and caspofungin (CAS) holds promise to improve the outcome of opportunistic invasive mycoses with poor prognosis. Little is known, however, about the safety and pharmacokinetics of the combination in patients at high risk for these infections. The safety and pharmacokinetics of the combination of LAMB and CAS were investigated in a risk-stratified, randomized, multicenter phase II clinical trial in 55 adult allogeneic hematopoietic stem cell recipients (aHSCT) with granulocytopenia and refractory fever. The patients received either CAS (50 mg/day; day 1, 70 mg), LAMB (3 mg/kg of body weight/day), or the combination of both (CASLAMB) until defervescence and granulocyte recovery. Safety, development of invasive fungal infections, and survival were assessed through day 14 after the end of therapy. Pharmacokinetic sampling and analysis were performed on days 1 and 4. All three regimens were well tolerated. Premature study drug discontinuations due to grade III/IV adverse events occurred in 1/18, 2/20, and 0/17 patients randomized to CAS, LAMB, and CASLAMB, respectively. Adverse events not leading to study drug discontinuation were frequent but similar across cohorts, except for a higher frequency of hypokalemia with CASLAMB (P < 0.05). Drug exposures were similar for patients receiving combination therapy and those randomized to monotherapy. There was no apparent difference in the occurrence of proven/probable invasive fungal infections and survival through day 14 after the end of therapy. CASLAMB combination therapy in immunocompromised aHSCT patients was as safe as monotherapy with CAS or LAMB and had similar plasma pharmacokinetics, lending support to further investigations of the combination in the management of patients with invasive opportunistic mycoses.

Indexed as

Hematopoietic Stem Cell TransplantationTransplantation, HomologousAdolescentAdultAgranulocytosisAmphotericin BAntifungal AgentsCaspofunginChildChild, PreschoolDrug Therapy, CombinationEchinocandinsFemaleHumansLipopeptidesMaleAmphotericin BAntifungal AgentsCaspofunginEchinocandinsLipopeptidesliposomal amphotericin B

Identifiers

PMID20660670
PMCPMC2944616
OpenAlexW2118169480

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.