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

NCT00509847 | Withdrawn Phase 1 DMC

• 1 other identifier: AMP SSTI 01-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcal Infections; Bacteremia

Keywords

S. epidermidis; Staphylococcus; Lactoferrin; hLF1-11; Bacteraemia

Outcome Measures

Primary Outcomes (1)

• Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring

  28 Days

Secondary Outcomes (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

  28 Days

Interventions

human lactoferrin peptide 1-11 DRUG

(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

Also known as: hLF1-11

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AM-Pharma: lead

Study Sites (1)

UMC St. Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Staphylococcal Infections; Bacteremia; Toxemia

Interventions

lactoferrin (1-11), human

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor P.E. Verweij, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 28, 2014

Record last verified: 2010-01

Locations

NL (1)