Staphylococcal InfectionsPhase 1/2LISTNCT00509847
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis
A Phase 1/2 study testing human lactoferrin peptide 1-11 in people with Staphylococcal Infections and Bacteremia, run by AM-Pharma at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Staphylococcal Infections, Bacteremia
- What is being tested?
- human lactoferrin peptide 1-11
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2009to Oct 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase-IIa, Double-blind, Randomized, Controlled Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Bacteremia Due to Staphylococcus Epidermidis
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.
Read the detailed description
RATIONALE FOR THE STUDY
Choice of Drug
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.
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess antibacterial effects on the selected bacteria (Staphylococcus epidermidis). Staphylococcus epidermidis is a commensal found in human skin. In current clinical practice hospital-acquired systemic Staphylococcal epidermidis is not routinely treated unless the bacteremia is accompanied by a clear clinical risk to the patient.
- Conditions
- Staphylococcal Infections, Bacteremia
- Being tested
- human lactoferrin peptide 1-11
- Keywords
- S. epidermidis, Staphylococcus, Lactoferrin, hLF1-11, Bacteraemia
- Medical subject headings
- Staphylococcal Infections, Bacteremia, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human lactoferrin peptide 1-11Drug
Also called hLF1-11
(A) hLF1-11 (once-daily 0.5mg IV for 10 days): Group #1, n=10; OR (B) Placebo (to match hLF1-11): Group #2, n=10
What is being measured
The primary outcome is the main question the study is designed to answer.
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring
Measured: 28 Days
Secondary outcomes (1)
Test of Cure (TOC): Microbiological: eradication of Staphylococcus epidermidis bacteria identified at baseline; and Clinical: complete resolution of any clinical signs and symptoms related to bacteraemia due to Staphylococcus epidermidis
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startFeb 2009
- Primary completionJul 2009 (estimated)
- Study completionOct 2009 (estimated)
Why it stopped: conduct (recruitment) not feasible within timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AM-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor P.E. Verweij, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509847
- Sponsor's protocol ID
- AMP SSTI 01-01
- Acronym
- LIST
- Status last verified
- Jan 2010
- First submitted
- 31 Jul 2007
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-IIa, Double-blind, Randomized, Controlled Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Bacteremia Due to Staphylococcus Epidermidis
- ClinicalTrials.gov ID
- NCT00509847
- Acronym / sponsor ID
- LIST / AMP SSTI 01-01
- Conditions
- Staphylococcal Infections, Bacteremia
- Keywords
- S. epidermidis, Staphylococcus, Lactoferrin, hLF1-11, Bacteraemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: conduct (recruitment) not feasible within timeframe
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AM-PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 1 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONALE FOR THE STUDY
Choice of Drug
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.
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess antibacterial effects on the selected bacteria (Staphylococcus epidermidis). Staphylococcus epidermidis is a commensal found in human skin. In current clinical practice hospital-acquired systemic Staphylococcal epidermidis is not routinely treated unless the bacteremia is accompanied by a clear clinical risk to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human lactoferrin peptide 1-11Also: hLF1-11(A) hLF1-11 (once-daily 0.5mg IV for 10 days): Group #1, n=10; OR (B) Placebo (to match hLF1-11): Group #2, n=10 | Drug | – |
Primary outcome
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring
Time frame: 28 Days
1 secondary outcome
Test of Cure (TOC): Microbiological: eradication of Staphylococcus epidermidis bacteria identified at baseline; and Clinical: complete resolution of any clinical signs and symptoms related to bacteraemia due to Staphylococcus epidermidis
Time frame: 28 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor P.E. Verweij, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human lactoferrin peptide 1-11 in people with Staphylococcal Infections and Bacteremia, run by AM-Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.