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

Abstract:

BACKGROUND:The 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. METHODS:We 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. RESULTS:Single 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. CONCLUSION:The 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 REGISTRATION:ClinicalTrials.gov: nct00509938.

journal_name

BMC Med

journal_title

BMC medicine

authors

Velden WJ,van Iersel TM,Blijlevens NM,Donnelly JP

doi

10.1186/1741-7015-7-44

subject

Has Abstract

pub_date

2009-09-08 00:00:00

pages

44

issn

1741-7015

pii

1741-7015-7-44

journal_volume

7

pub_type

杂志文章,随机对照试验
  • Causes of death after fluid bolus resuscitation: new insights from FEAST.

    abstract::The Fluid Expansion as Supportive Therapy (FEAST study) was an extremely well conducted study that gave unexpected results. The investigators had reported that febrile children with impaired perfusion treated in low-income countries without access to intensive care are more likely to die if they receive bolus resuscit...

    journal_title:BMC medicine

    pub_type: 评论,杂志文章

    doi:10.1186/1741-7015-11-67

    authors: Myburgh J,Finfer S

    更新日期:2013-03-14 00:00:00

  • Migraine aura or transient ischemic attacks? A five-year follow-up case-control study of women with transient central nervous system disorders in pregnancy.

    abstract:BACKGROUND:Migraine aura may be difficult to differentiate from transient ischemic attacks and other transient neurological disorders in pregnant women. The aims of the present study were to investigate and diagnose all pregnant women with transient neurological disorders of suspected central nervous system origin, and...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-5-19

    authors: Ertresvg JM,Stovner LJ,Kvavik LE,Johnsen HJ,Zwart JA,Helde G,Bovim G

    更新日期:2007-07-17 00:00:00

  • Ultrasound and dynamic functional imaging in vascular cognitive impairment and Alzheimer's disease.

    abstract:BACKGROUND:The vascular contributions to neurodegeneration and neuroinflammation may be assessed by magnetic resonance imaging (MRI) and ultrasonography (US). This review summarises the methodology for these widely available, safe and relatively low cost tools and analyses recent work highlighting their potential utili...

    journal_title:BMC medicine

    pub_type: 杂志文章,评审

    doi:10.1186/s12916-017-0799-3

    authors: Malojcic B,Giannakopoulos P,Sorond FA,Azevedo E,Diomedi M,Oblak JP,Carraro N,Boban M,Olah L,Schreiber SJ,Pavlovic A,Garami Z,Bornstein NM,Rosengarten B

    更新日期:2017-02-09 00:00:00

  • Improving performance of the Tariff Method for assigning causes of death to verbal autopsies.

    abstract:BACKGROUND:Reliable data on the distribution of causes of death (COD) in a population are fundamental to good public health practice. In the absence of comprehensive medical certification of deaths, the only feasible way to collect essential mortality data is verbal autopsy (VA). The Tariff Method was developed by the ...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-015-0527-9

    authors: Serina P,Riley I,Stewart A,James SL,Flaxman AD,Lozano R,Hernandez B,Mooney MD,Luning R,Black R,Ahuja R,Alam N,Alam SS,Ali SM,Atkinson C,Baqui AH,Chowdhury HR,Dandona L,Dandona R,Dantzer E,Darmstadt GL,Das V,Dh

    更新日期:2015-12-08 00:00:00

  • Combining serological and contact data to derive target immunity levels for achieving and maintaining measles elimination.

    abstract:BACKGROUND:Vaccination has reduced the global incidence of measles to the lowest rates in history. However, local interruption of measles virus transmission requires sustained high levels of population immunity that can be challenging to achieve and maintain. The herd immunity threshold for measles is typically stipula...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-019-1413-7

    authors: Funk S,Knapp JK,Lebo E,Reef SE,Dabbagh AJ,Kretsinger K,Jit M,Edmunds WJ,Strebel PM

    更新日期:2019-09-25 00:00:00

  • Development and evaluation of the feasibility and effects on staff, patients, and families of a new tool, the Psychosocial Assessment and Communication Evaluation (PACE), to improve communication and palliative care in intensive care and during clinical u

    abstract:BACKGROUND:There are widespread concerns about communication and support for patients and families, especially when they face clinical uncertainty, a situation most marked in intensive care units (ICUs). Therefore, we aimed to develop and evaluate an interventional tool to improve communication and palliative care, usi...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-11-213

    authors: Higginson IJ,Koffman J,Hopkins P,Prentice W,Burman R,Leonard S,Rumble C,Noble J,Dampier O,Bernal W,Hall S,Morgan M,Shipman C

    更新日期:2013-10-01 00:00:00

  • Colorectal cancer screening: the time to act is now.

    abstract:BACKGROUND:Colorectal cancer (CRC) is the third most common cancer and the fourth most common cause of cancer deaths globally. However, there is overwhelming evidence that a large proportion of CRC cases and deaths could be prevented by screening. Nevertheless, CRC screening programmes are offered in a minority of coun...

    journal_title:BMC medicine

    pub_type: 杂志文章,评审

    doi:10.1186/s12916-015-0498-x

    authors: Brenner H,Stock C,Hoffmeister M

    更新日期:2015-10-13 00:00:00

  • Hospital admissions in relation to body mass index in UK women: a prospective cohort study.

    abstract:BACKGROUND:Adiposity is associated with many adverse health outcomes but little direct evidence exists about its impact on the use of health care services. We aim to describe the relationship between body mass index (BMI) and rates of hospital admission in middle-aged UK women. METHODS:Among 1,251,619 Million Women St...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-12-45

    authors: Reeves GK,Balkwill A,Cairns BJ,Green J,Beral V,Million Women Study Collaborators.

    更新日期:2014-03-15 00:00:00

  • Attention bias modification: the Emperor's new suit?

    abstract::A series of primarily laboratory-based studies found attention bias modification in socially anxious participants to lead to reduced anxiety. It is argued that the failure to replicate the positive results of attention bias modification in the study of Carlbring et al. may be due to reasons other than the application ...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-10-63

    authors: Emmelkamp PM

    更新日期:2012-06-25 00:00:00

  • Cardiac-specific catalase overexpression rescues anthrax lethal toxin-induced cardiac contractile dysfunction: role of oxidative stress and autophagy.

    abstract:BACKGROUND:Lethal and edema toxins secreted by Bacillus anthracis during anthrax infection were found to incite serious cardiovascular complications. However, the underlying mechanisms in anthrax lethal toxin-induced cardiac anomalies remain unknown. This study was designed to evaluate the impact of antioxidant enzyme ...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-10-134

    authors: Kandadi MR,Yu X,Frankel AE,Ren J

    更新日期:2012-11-07 00:00:00

  • Constitutive phosphorylated STAT3-associated gene signature is predictive for trastuzumab resistance in primary HER2-positive breast cancer.

    abstract:BACKGROUND:The likelihood of recurrence in patients with breast cancer who have HER2-positive tumors is relatively high, although trastuzumab is a remarkably effective drug in this setting. Signal transducer and activator of transcription 3 protein (STAT3), a transcription factor that is persistently tyrosine-705 phosp...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-015-0416-2

    authors: Sonnenblick A,Brohée S,Fumagalli D,Vincent D,Venet D,Ignatiadis M,Salgado R,Van den Eynden G,Rothé F,Desmedt C,Neven P,Loibl S,Denkert C,Joensuu H,Loi S,Sirtaine N,Kellokumpu-Lehtinen PL,Piccart M,Sotiriou C

    更新日期:2015-08-03 00:00:00

  • Discontinuation of adjuvant hormone therapy among breast cancer patients not previously attending mammography screening.

    abstract:BACKGROUND:Breast cancer patients who have not previously attended mammography screening may be more likely to discontinue adjuvant hormone therapy and therefore have a worse disease prognosis. METHODS:We conducted a population-based cohort study using data from Stockholm Mammography Screening Program, Stockholm-Gotla...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-019-1252-6

    authors: He W,Eriksson L,Törnberg S,Strand F,Hall P,Czene K

    更新日期:2019-01-31 00:00:00

  • The 2014 Ebola virus disease outbreak in Pujehun, Sierra Leone: epidemiology and impact of interventions.

    abstract:BACKGROUND:In July 2014, an outbreak of Ebola virus disease (EVD) started in Pujehun district, Sierra Leone. On January 10th, 2015, the district was the first to be declared Ebola-free by local authorities after 49 cases and a case fatality rate of 85.7%. The Pujehun outbreak represents a precious opportunity for impro...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-015-0524-z

    authors: Ajelli M,Parlamento S,Bome D,Kebbi A,Atzori A,Frasson C,Putoto G,Carraro D,Merler S

    更新日期:2015-11-26 00:00:00

  • Cardiovascular implications of COVID-19 versus influenza infection: a review.

    abstract:BACKGROUND:Due to the overlapping clinical features of coronavirus disease 2019 (COVID-19) and influenza, parallels are often drawn between the two diseases. Patients with pre-existing cardiovascular diseases (CVD) are at a higher risk for severe manifestations of both illnesses. Considering the high transmission rate ...

    journal_title:BMC medicine

    pub_type: 杂志文章,评审

    doi:10.1186/s12916-020-01816-2

    authors: Khan MS,Shahid I,Anker SD,Solomon SD,Vardeny O,Michos ED,Fonarow GC,Butler J

    更新日期:2020-12-18 00:00:00

  • Mirror, mirror on the wall: which microbiomes will help heal them all?

    abstract:BACKGROUND:Clinicians have known for centuries that there is substantial variability between patients in their response to medications-some individuals exhibit a miraculous recovery while others fail to respond at all. Still others experience dangerous side effects. The hunt for the factors responsible for this variati...

    journal_title:BMC medicine

    pub_type: 社论

    doi:10.1186/s12916-016-0622-6

    authors: Nayak RR,Turnbaugh PJ

    更新日期:2016-05-04 00:00:00

  • The normal breast microenvironment of premenopausal women differentially influences the behavior of breast cancer cells in vitro and in vivo.

    abstract:BACKGROUND:Breast cancer studies frequently focus on the role of the tumor microenvironment in the promotion of cancer; however, the influence of the normal breast microenvironment on cancer cells remains relatively unknown. To investigate the role of the normal breast microenvironment on breast cancer cell tumorigenic...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-8-27

    authors: Fleming JM,Miller TC,Quinones M,Xiao Z,Xu X,Meyer MJ,Ginsburg E,Veenstra TD,Vonderhaar BK

    更新日期:2010-05-21 00:00:00

  • Model-based comorbidity clusters in patients with heart failure: association with clinical outcomes and healthcare utilization.

    abstract:BACKGROUND:Comorbidities affect outcomes in heart failure (HF), but are not reflected in current HF classification. The aim of this study is to characterize HF groups that account for higher-order interactions between comorbidities and to investigate the association between comorbidity groups and outcomes. METHODS:Lat...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-020-01881-7

    authors: Gulea C,Zakeri R,Quint JK

    更新日期:2021-01-18 00:00:00

  • There are no randomized controlled trials that support the United States Preventive Services Task Force Guideline on screening for depression in primary care: a systematic review.

    abstract:BACKGROUND:The United States Preventive Services Task Force (USPSTF) recommends screening adults for depression in primary care settings when staff-assisted depression management programs are available. This recommendation, however, is based on evidence from depression management programs conducted with patients alread...

    journal_title:BMC medicine

    pub_type: 杂志文章,评审

    doi:10.1186/1741-7015-12-13

    authors: Thombs BD,Ziegelstein RC,Roseman M,Kloda LA,Ioannidis JP

    更新日期:2014-01-28 00:00:00

  • Coagulopathy triggered autoimmunity: experimental antiphospholipid syndrome in factor V Leiden mice.

    abstract:BACKGROUND:We investigated interactions between genetically and autoimmune-mediated coagulopathies by inducing experimental antiphospholipid syndrome (eAPS) in mice carrying the factor V Leiden (FVL) mutation. METHODS:eAPS was induced in heterozygous and homozygous FVL transgenic mice (C57BL/6 background) by immunizat...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-11-92

    authors: Katzav A,Grigoriadis NC,Ebert T,Touloumi O,Blank M,Pick CG,Shoenfeld Y,Chapman J

    更新日期:2013-04-04 00:00:00

  • State of inequality in malaria intervention coverage in sub-Saharan African countries.

    abstract:BACKGROUND:Scale-up of malaria interventions over the last decade have yielded a significant reduction in malaria transmission and disease burden in sub-Saharan Africa. We estimated economic gradients in the distribution of these efforts and of their impacts within and across endemic countries. METHODS:Using Demograph...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-017-0948-8

    authors: Galactionova K,Smith TA,de Savigny D,Penny MA

    更新日期:2017-10-18 00:00:00

  • Predicting the response to sorafenib in hepatocellular carcinoma: where is the evidence for phosphorylated extracellular signaling-regulated kinase (pERK)?

    abstract::The approval of sorafenib and active development of many other molecularly targeted agents in hepatocellular carcinoma (HCC) have presented a challenge to understand the mechanism of action of sorafenib and identify predictive biomarkers to select patients more likely to benefit from sorafenib. The preclinical study b...

    journal_title:BMC medicine

    pub_type: 社论

    doi:10.1186/1741-7015-7-42

    authors: Zhu AX

    更新日期:2009-08-24 00:00:00

  • The link between chronic periodontitis and COPD: a common role for the neutrophil?

    abstract:BACKGROUND:The possible relationship between chronic inflammatory diseases and their co-morbidities has become an increasing focus of research. Both chronic periodontitis and chronic obstructive pulmonary disease are neutrophilic, inflammatory conditions characterized by the loss of local connective tissue. Evidence su...

    journal_title:BMC medicine

    pub_type: 杂志文章,评审

    doi:10.1186/1741-7015-11-241

    authors: Usher AK,Stockley RA

    更新日期:2013-11-13 00:00:00

  • Chronic fatigue syndrome in an ethnically diverse population: the influence of psychosocial adversity and physical inactivity.

    abstract:BACKGROUND:Chronic fatigue syndrome (CFS) is a complex multifactorial disorder. This paper reports the prevalence of chronic fatigue (CF) and CFS in an ethnically diverse population sample and tests whether prevalence varies by social adversity, social support, physical inactivity, anxiety and depression. METHODS:Anal...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/1741-7015-9-26

    authors: Bhui KS,Dinos S,Ashby D,Nazroo J,Wessely S,White PD

    更新日期:2011-03-21 00:00:00

  • Is inhibition of kinase activity the only therapeutic strategy for LRRK2-associated Parkinson's disease?

    abstract::Mutations in the leucine-rich repeat kinase 2 (LRRK2) gene are a common cause of familial Parkinson's disease (PD). Variation around the LRRK2 locus also contributes to the risk of sporadic PD. The LRRK2 protein contains a central catalytic region, and pathogenic mutations cluster in the Ras of complex protein C termi...

    journal_title:BMC medicine

    pub_type: 杂志文章,评审

    doi:10.1186/1741-7015-10-20

    authors: Rudenko IN,Chia R,Cookson MR

    更新日期:2012-02-23 00:00:00

  • A systematic review and analysis of long-term outcomes in attention deficit hyperactivity disorder: effects of treatment and non-treatment.

    abstract:BACKGROUND:In childhood, attention deficit/hyperactivity disorder (ADHD) is characterized by age-inappropriate levels of inattentiveness/disorganization, hyperactivity/impulsiveness, or a combination thereof. Although the criteria for ADHD are well defined, the long-term consequences in adults and children need to be m...

    journal_title:BMC medicine

    pub_type: 杂志文章,meta分析,评审

    doi:10.1186/1741-7015-10-99

    authors: Shaw M,Hodgkins P,Caci H,Young S,Kahle J,Woods AG,Arnold LE

    更新日期:2012-09-04 00:00:00

  • Lactate clearance as a prognostic marker of mortality in severely ill febrile children in East Africa.

    abstract:BACKGROUND:Hyperlactataemia (HL) is a biomarker of disease severity that predicts mortality in patients with sepsis and malaria. Lactate clearance (LC) during resuscitation has been shown to be a prognostic factor of survival in critically ill adults, but little data exist for African children living in malaria-endemic...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-018-1014-x

    authors: Aramburo A,Todd J,George EC,Kiguli S,Olupot-Olupot P,Opoka RO,Engoru C,Akech SO,Nyeko R,Mtove G,Gibb DM,Babiker AG,Maitland K

    更新日期:2018-03-09 00:00:00

  • Lactate dehydrogenase and susceptibility to deterioration of mild COVID-19 patients: a multicenter nested case-control study.

    abstract:BACKGROUND:Coronavirus disease 2019 (COVID-19) has infected more than 4 million people within 4 months. There is an urgent need to properly identify high-risk cases that are more likely to deteriorate even if they present mild diseases on admission. METHODS:A multicenter nested case-control study was conducted in four...

    journal_title:BMC medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1186/s12916-020-01633-7

    authors: Shi J,Li Y,Zhou X,Zhang Q,Ye X,Wu Z,Jiang X,Yu H,Shao L,Ai JW,Zhang H,Xu B,Sun F,Zhang W

    更新日期:2020-06-03 00:00:00

  • How and why weight stigma drives the obesity 'epidemic' and harms health.

    abstract:BACKGROUND:In an era when obesity prevalence is high throughout much of the world, there is a correspondingly pervasive and strong culture of weight stigma. For example, representative studies show that some forms of weight discrimination are more prevalent even than discrimination based on race or ethnicity. DISCUSSI...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-018-1116-5

    authors: Tomiyama AJ,Carr D,Granberg EM,Major B,Robinson E,Sutin AR,Brewis A

    更新日期:2018-08-15 00:00:00

  • The equity impact of brief opportunistic interventions to promote weight loss in primary care: secondary analysis of the BWeL randomised trial.

    abstract:BACKGROUND:Guidelines recommend that clinicians should make brief opportunistic behavioural interventions to patients who are obese to increase the uptake of effective weight loss programmes. The objective was to assess the effect of this policy on socioeconomic equity. METHODS:One thousand eight hundred eighty-two co...

    journal_title:BMC medicine

    pub_type: 杂志文章,随机对照试验

    doi:10.1186/s12916-019-1284-y

    authors: Graham J,Tudor K,Jebb SA,Lewis A,Tearne S,Adab P,Begh R,Jolly K,Daley A,Farley A,Lycett D,Nickless A,Aveyard P

    更新日期:2019-03-01 00:00:00

  • Antidepressant use and cognitive decline in community-dwelling elderly people - The Three-City Cohort.

    abstract:BACKGROUND:Cognitive impairment is very common in late-life depression, principally affecting executive skills and information processing speed. The aim of the study was to examine the effect of antidepressant treatment on cognitive performances over a 10-year period. METHODS:The community-based cohort included 7381 p...

    journal_title:BMC medicine

    pub_type: 杂志文章

    doi:10.1186/s12916-017-0847-z

    authors: Carrière I,Norton J,Farré A,Wyart M,Tzourio C,Noize P,Pérès K,Fourrier-Réglat A,Ritchie K,Ancelin ML

    更新日期:2017-04-19 00:00:00