A phase-I, double-blind, randomized, controlled study on the tolerability and early efficacy of hLF1-11 in hospitalized patients with bacteremia due to Staphylococcus epidermidis. - not applicable

AM-Pharma B.V.0 sites20 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

AM-Pharma B.V.

•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.

•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.