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

May 26, 2014 updated by: AM-Pharma

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

RATIONALE FOR THE STUDY

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

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • UMC St. Radboud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AM-Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2009

Study Completion (ANTICIPATED)

October 1, 2009

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (ESTIMATE)

August 1, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP SSTI 01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacteremia

Clinical Trials on human lactoferrin peptide 1-11

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe