A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis (LIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509847
Recruitment Status : Withdrawn (conduct (recruitment) not feasible within timeframe)
First Posted : August 1, 2007
Last Update Posted : May 28, 2014
Information provided by:

Brief Summary:
The purpose of this study is to establish the tolerability of treatment with human lactoferrin 1-11 peptide (hLF1-11) administered intravenously as a single dose given for 10 consecutive days, to patients with bacteremia due to staphylococcus epidermidis.

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Bacteremia Drug: human lactoferrin peptide 1-11 Phase 1 Phase 2

Detailed Description:


Choice of Drug

Staphylococcus epidermidis is a relatively uncommon find in blood cultures, most cases being found in patients with intravenous lines through contiguous contamination and current clinical practice is often one of not using antibiotic treatment immediately, unless significant clinical signs and symptoms and/or patient status justifies intervention with an antibiotic. The latter tends to be vancomycin as many S epidermidis strains are resistant to other agents.

hLF1-11 is hypothesized to have antibacterial effects against Staphylococcus epidermidis, amongst other strains.

Should hLF1-11 be shown to be an effective antibacterial against Staphylococcus epidermidis, its use would be justified in other more serious hospital-acquired infections such as MRSA for which hLF1-11 has been shown (in preclinical in vitro and in vivo data) to display a strong therapeutic effect.

Choice of Patient Population

Based on preclinical data hLF1-11 has been shown to possess antibacterial effects on the selected bacteria (Staphylococcus epidermidis). Staphylococcus epidermidis is a commensal found in human skin. In current clinical practice hospital-acquired systemic Staphylococcal epidermidis is not routinely treated unless the bacteremia is accompanied by a clear clinical risk to the patient.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase-IIa, Double-blind, Randomized, Controlled Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Bacteremia Due to Staphylococcus Epidermidis
Study Start Date : February 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : October 2009

Intervention Details:
    Drug: human lactoferrin peptide 1-11
    (A) hLF1-11 (once-daily 0.5mg IV for 10 days): Group #1, n=10; OR (B) Placebo (to match hLF1-11): Group #2, n=10
    Other Name: hLF1-11

Primary Outcome Measures :
  1. Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Test of Cure (TOC): Microbiological: eradication of Staphylococcus epidermidis bacteria identified at baseline; and Clinical: complete resolution of any clinical signs and symptoms related to bacteraemia due to Staphylococcus epidermidis [ Time Frame: 28 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hospitalized patients with positive blood culture for Staphylococcus epidermidis.
  • Diagnosis of staphylococcal infection based on a positive culture for Staphylococcus epidermidis on 2 consecutive occasions within 12 hours.
  • Study medication must be started not later than 24 hours of the last qualifying positive blood culture.
  • Patients for whom antibiotic treatment is not clinically indicated at the start of the study.
  • Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables.
  • Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
  • Fecund females patients must not be pregnant (confirmed by pregnancy test at entry) and must be on appropriate mechanical (intra-uterine device) or pharmacological ("pill") contraception.
  • Written informed consent must be obtained before admission in the study.

Exclusion Criteria:

  • Prior antibiotic usage: patients who have received (within 48 hours of study entry) a systemic anti-staphylococcal antibiotic for longer than 24 hours.
  • Concomitant antibiotic or anti-bacterial agents except as allowed by the protocol or in life-threatening complications.
  • Patients with devices infected with Staphylococcus epidermidis or other important pathogens, including in implants, heart valves and catheters.
  • Patients known to have AIDS or who are HIV-positive.
  • Neutropenic patients with neutrophil count below 0.5x10^9/L.
  • Patients with staphylococcal endocarditis, mediastinitis, meningitis, osteomyelitis and/or joint infections, lung/pleural infections, septic shock.
  • Patients with methicillin-sensitive coagulase-negative staphylococcus (CNS) infections (MSSE).
  • Patients who have known hypersensitivity to any constituent of hLF1-11.
  • Patients who have received an investigational drug within three months prior to the study that may interfere with the interpretation of study results.
  • Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
  • Patients considered inappropriate by the PI for enrolment in the study, for any reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509847

UMC St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Principal Investigator: Professor P.E. Verweij, MD, PhD UMC St. Radboud, Nijmegen, The Netherlands

Additional Information:
Responsible Party: Dr J Arend, MD, AM-Pharma Identifier: NCT00509847     History of Changes
Other Study ID Numbers: AMP SSTI 01-01
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: January 2010

Keywords provided by AM-Pharma:
S. epidermidis

Additional relevant MeSH terms:
Staphylococcal Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Gram-Positive Bacterial Infections
Anti-Infective Agents