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

• Status: Withdrawn
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AM-Pharma
• Treatments: Lactoferrin

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.