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.
- Conditions
- bacterial skin infectionStaphylococcus Epidermidis infection10004018
- Registration Number
- NL-OMON31208
- Lead Sponsor
- AM-Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
• 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.
• Patients considered inappropriate by the PI for enrolment in the study, for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• To investigate the safety of hLF1-11 in patients with Staphylococcus<br /><br>epidermidis-positive blood cultures.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To obtain in vitro susceptibility data on staphylococcal infections from<br /><br>patients participating in the study.<br /><br>• To explore the relationship of drug exposure to cure rates (TOC) in<br /><br>bacteriologically (blood culture) evaluable patients.</p><br>