bacterial skin infection Staphylococcus Epidermidis infection
Conditions
Interventions
0.5mg hLF1-11 given once daily for 10 consecutive days.
Sponsors
AM-Pharma B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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 0.5x109/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To investigate the safety of hLF1-11 in patients with Staphylococcus epidermidis-positive blood cultures. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To obtain in vitro susceptibility data on staphylococcal infections from patients participating in the study. • To explore the relationship of drug exposure to cure rates (TOC) in bacteriologically (blood culture) evaluable patients. | — |
Countries
Netherlands
Outcome results
None listed