Evidence map›Paper›PMID 19735580›Full record

Trial reportBMC medicine2009

Safety and tolerability of the antimicrobial peptide human lactoferrin 1-11 (hLF1-11).

Walter J F M van der Velden, Thijs M P van Iersel, Nicole M A Blijlevens, J Peter Donnelly

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00509938 (Safety and Efficacy of Human Lactoferrin hLF1-11 for the Treatment of Infectious Complications Among Haematopoietic Stem Cell Transplant Recipients Part A), which is not on this map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
7.5field-weighted citation impact, top 3% 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.

NCT00509938 phase1 / phase2completednot on this map

Safety and Efficacy of Human Lactoferrin hLF1-11 for the Treatment of Infectious Complications Among Haematopoietic Stem Cell Transplant Recipients Part A: Clinical Study Protocol SC12: Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients

TypeinterventionalSponsorAM-PharmaRan2006 to 2006Enrolled8ConditionsHematopoietic Stem Cell Transplantation, Bacterial Infections and MycosesArmshuman lactoferrin peptide 1-11
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 114 citations in OpenAlex.

  1. Roles of d-Amino Acids on the Bioactivity of Host Defense Peptides.International journal of molecular sciences · 2016
    Pooled it
  2. Review
  3. Emerging antimicrobial peptides in gastrointestinal disorders: Dual role in immunity and therapy.World journal of gastrointestinal pharmacology and therapeutics · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Nanomedicine: New Frontiers in Fighting Microbial Infections.Nanomaterials (Basel, Switzerland) · 2023
    Review
  16. Review
  17. Antibiotics (Basel, Switzerland) · 2022
    Article
  18. Review
  19. Review
  20. Review
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

4 authors at 3 institutions in 1 country.

Walter J F M van der VeldenDepartment of Haematology, Radboud University Nijmegen Medical Centre, The Netherlands. w.vandervelden@hemat.umcn.nl
Thijs M P van Iersel
Nicole M A Blijlevens
J Peter Donnelly
Radboud University Nijmegen · NLRadboud University Medical Center · NLXendo (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe treatment of patients with haematological malignancies by means of haematopoietic stem cell transplantation (HSCT) is often accompanied by life threatening infections. With emerging antimicrobial resistance there is an increased need for new agents, with a beneficial safety profile. Therefore we evaluated the safety of the promising new antimicrobial peptide human lactoferrrin 1-11 (hLF1-11) in healthy volunteers and patients.

methodsWe undertook a sequential, randomised, double-blind, placebo-controlled study using ascending single (0.005, 0.05, 0.5, 5 mg) and multiple intravenous doses (0.5, 5 mg) in healthy volunteers, and open-label, single intravenous 5 mg doses in autologous HSCT recipients.

resultsSingle and multiple doses of hLF1-11 were tolerable up to 5 mg intravenously in healthy volunteers, while 5 mg single dose was tolerable in patients. Elevations in transaminases possibly related to treatment were reversible and not serious.

conclusionThe new antimicrobial hLF1-11 is well tolerated in healthy volunteers with repeated daily doses up to 5 mg. The side-effect profile is very favourable for an antimicrobial, the only undesirable effect being a possible elevation of transaminases, which may be related to hLF1-11 although the current data do not allow conclusive interpretation of treatment relationship. A lower dose is recommended for the forthcoming multiple dosing studies in HSCT patients.

trial registrationClinicalTrials.gov: nct00509938.

Indexed as

AdolescentAdultAnti-Infective AgentsDouble-Blind MethodFemaleHumansInjections, IntravenousLactoferrinMaleMiddle AgedPeptide FragmentsPlacebosTransaminasesYoung AdultAnti-Infective AgentsLactoferrinlactoferrin (1-11), humanPeptide FragmentsPlacebosTransaminases

Identifiers

PMID19735580
PMCPMC2746231
OpenAlexW2068479106

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.