Evidence map›Paper›PMID 10808210›Full record

Trial reportBone marrow transplantation2000

Amphotericin B colloidal dispersion (Amphocil) vs fluconazole for the prevention of fungal infections in neutropenic patients: data of a prematurely stopped clinical trial.

G J Timmers, S Zweegman, A M Simoons-Smit, A C van Loenen, D Touw, P C Huijgens

Abstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
2.7field-weighted citation impact, top 10% 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

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  4. Adverse effects of antifungal therapies in invasive fungal infections: review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2006
    Pooled it
  5. Adverse effects of antifungal therapies in invasive fungal infections: review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2005
    Pooled it
  6. Article
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  8. Article
  9. Review
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  11. Tolerability profile of the current antifungal armoury.The Journal of antimicrobial chemotherapy · 2018
    Review
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  17. Article
  18. Article
  19. Lipid-based nanoparticles as pharmaceutical drug carriers: from concepts to clinic.Critical reviews in therapeutic drug carrier systems · 2009
    Review
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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

6 authors at 2 institutions in 2 countries.

G J TimmersDepartment of Haematology, University Hospital Vrije Universiteit, Amsterdam, The Netherlands.
S Zweegman
A M Simoons-Smit
A C van Loenen
D Touw
P C Huijgens
Vrije Universiteit Amsterdam · NLTarget (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We conducted an open label, randomised clinical trial to compare amphotericin B colloidal dispersion (ABCD, Amphocil) 2 mg/kg/day intravenously with fluconazole 200 mg/day orally, for the prevention of fungal disease in neutropenic patients with haematological malignancies. In the event of unresolved fever after 4 days of empirical antibacterial therapy, patients in both treatment groups were to receive ABCD, 4 mg/kg/day. However, the study had to be stopped in an early phase, due to severe side-effects of ABCD. A total of 24 patients were enrolled, 12 patients were randomly assigned to receive prophylactic ABCD, which was administered for a mean of 13.9 days. Fluconazole prophylaxis was given to 12 patients for a mean of 21.2 days. Therapeutic ABCD, 4 mg/kg, was initiated in four patients because of suspected fungal infection, all of whom had initially received fluconazole. A high rate of infusion-related toxicity of ABCD was observed. Chills occurred in 15/16 ABCD recipients (94%), accompanied by a temperature rise of >/=2 degrees C in 4/16 patients and of >/=1 degrees C but <2 degrees C in 10/16 patients. Other ABCD-related adverse events were hypotension (4/16), nausea with vomiting (5/16), tachycardia (7/16), headache (3/16) and dyspnoea (3/16). For premedication patients received: antihistamines (12/16), hydrocortisone (9/16) and/or morphine (6/16). ABCD was discontinued in 8/16 patients (50%) due to side-effects, which ultimately dictated early termination of the study. We conclude that ABCD is not suitable for antifungal prophylaxis in neutropenic patients due to severe infusion-related side-effects. Subject numbers were too low for conclusions on variables of antifungal efficacy.

Indexed as

AdolescentAdultAgedAmphotericin BBilirubinConsumer Product SafetyContraindicationsFemaleFluconazoleHematologic NeoplasmsHematopoietic Stem Cell TransplantationHumansInfusions, IntravenousMaleMiddle AgedMorphineAmphotericin BBilirubinFluconazoleMorphineTransaminases

Identifiers

PMID10808210
OpenAlexW2082689534

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.