A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis - Full Text View

Sponsored by:	AM-Pharma
Information provided by:	AM-Pharma
ClinicalTrials.gov Identifier:	NCT00509847

Purpose

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	Intervention	Phase
Staphylococcal Infections Bacteremia	Drug: human lactoferrin peptide 1-11	Phase I Phase II

MedlinePlus related topics: Staphylococcal Infections

Drug Information available for: Lactoferrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AM-Pharma:

Primary Outcome Measures:

Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

(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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509847

Locations

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

Sponsors and Collaborators

AM-Pharma

Investigators

Principal Investigator:

Professor P.E. Verweij, MD, PhD

UMC St. Radboud Nijmegen, The Netherlands

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	AM-Pharma ( Dr J Arend, MD )
Study ID Numbers:	AMP SSTI 01-01
Study First Received:	July 31, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00509847
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AM-Pharma:

S. epidermidis
Staphylococcus
Lactoferrin
hLF1-11
Bacteraemia

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections

Sepsis
Bacteremia
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009