To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 10 days
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To investigate the safety of hLF1-11 in patients with Staphylococcus
epidermidis-positive blood cultures.
Secondary outcome
• 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.
Background summary
Staphylococcus epidermidis is a relatively uncommon find in blood cultures,
most cases being found in patients with intravenous lines through contiguous
contamination and current clinical practice is often one of not using
antibiotic treatment immediately, unless significant clinical signs and
symptoms and/or patient status justifies intervention with an antibiotic. The
latter tends to be vancomycin as many S epidermidis strains are resistant to
other agents.
hLF1-11 is hypothesized to have antibacterial effects against Staphylococcus
epidermidis, amongst other strains.
Should hLF1-11 be shown to be an effective antibacterial against Staphylococcus
epidermidis, its use would be justified in other more serious hospital-acquired
infections such as MRSA for which hLF1-11 has been shown (in preclinical in
vitro and in vivo data) to display a strong therapeutic effect.
Study objective
To establish the safety, tolerability, and early efficacy of multiple doses of
hLF1-11 given once daily for 10 days
Study design
This phase-I, double-blind, randomized, controlled study is designed to study
the tolerability and early efficacy of hLF1-11 in hospitalized patients with
bacteremia due to Staphylococcus epidermidis.
Two groups of 10 patients (2 groups of n=10, N=20) will be included. One group
will be treated with hLF1-11 and the other will receive matching placebo.
Although S epidermidis is not routinely treated with antibiotics, all patients
may also receive any antibiotic that becomes indicated after 96 hours from
start of study medication.
All decisions on *tolerability* will be made by the Principal Investigator(s)
in consultation with the Independent Data Safety Monitoring Committee (IDSMC)
who will oversee all safety aspects of the study on an ongoing basis and will
advise the PI(s) and Sponsor including on implementation of stopping rules
under separate protocol (available upon request).
N=20 (2 groups of N=10)
Randomization ratio: 1:1
Intervention
0.5mg hLF1-11 given once daily for 10 consecutive days.
Study burden and risks
Extra blood will be drawn through the central venous catheter
Rumpsterweg 6
3981 AK, Bunnik
Nederland
Rumpsterweg 6
3981 AK, Bunnik
Nederland
Listed location countries
Age
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 0.5x109/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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003869-40-NL |
| CCMO | NL18833.091.07 |