CandidaemiaPhase 1/2SLICNCT00509834
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia
A Phase 1/2 study testing hLF1-11 in people with Candidaemia, run by AM-Pharma at 1 site in Netherlands.
Trial summary
This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Candidaemia
- What is being tested?
- hLF1-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Jan 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
- Written informed consent must be obtained before admission in the study.
- Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.
- Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.
- Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
Who cannot join
- Patients with a history of hypersensitivity to fluconazole or hLF1-11.
- Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.
- Patients with a history of fluconazole-resistant Candida species within 12 weeks.
- Neutropenic patients with neutrophil count below 0.5x10^9/L.
- Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
- Patients known to have AIDS or who are HIV-positive.
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- Females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical).
- Patients with suspected candida osteomyelitis, endocarditis, or meningitis.
- Patients who have received an investigational drug within three months prior to the study.
- 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 enrollment 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 Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Proven Candidaemia. (SLIC: Study of Lactoferrin Peptide in Infections With Candida)
This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.
Read the detailed description
RATIONALE FOR THE STUDY
Choice of Drug
Fluconazole is considered "standard care" for the treatment of Candida infections, including candidaemia in hospitalized patients.
Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and, importantly, to be synergistic with fluconazole, whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo. Furthermore, candidaemia (bloodstream Candida infection) is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation
As previously mentioned, fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies, whereby the effect of fluconazole is enhanced by the addition of hLF1-11.
- Conditions
- Candidaemia
- Being tested
- hLF1-11, Placebo
- Keywords
- hLF1-11, Candida, candidaemia, lactoferrin
- Medical subject headings
- Candidemia, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hLF1-11Drug
The study treatment consists of IV administration of:
(A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10
hLF1-11Drug
Also called human lactoferrin 1-11
0.5mg hLF1-11 iv per day for 14 consecutive days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| hLF1-11 | Experimental | hLF1-11 0.5mg Receives: Drug: hLF1-11 |
| Placebo | Placebo comparator | Placebo formulation is Similar to hLF1-11 iv formulation except for the active component Receives: Drug: Placebo |
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): Clinical: complete resolution of clinical signs and symptoms or resolution to a point where no further antifungal therapy is judged necessary; and Microbiological: eradication of Candida identified at baseline.
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 startJul 2008
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: Patient population not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidaemiaStudies 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)
- Responsible party
- Sponsor
- Investigators
- Professor P.E. Verweij, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509834
- Sponsor's protocol ID
- AMP IC 01-01
- Acronym
- SLIC
- Status last verified
- Apr 2008
- First submitted
- 31 Jul 2007
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-IIa, Double-blind, Randomized Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Proven Candidaemia. (SLIC: Study of Lactoferrin Peptide in Infections With Candida)
- ClinicalTrials.gov ID
- NCT00509834
- Acronym / sponsor ID
- SLIC / AMP IC 01-01
- Conditions
- Candidaemia
- Keywords
- hLF1-11, Candida, candidaemia, lactoferrin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patient population not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AM-PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 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.
This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.
Detailed description
RATIONALE FOR THE STUDY
Choice of Drug
Fluconazole is considered "standard care" for the treatment of Candida infections, including candidaemia in hospitalized patients.
Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and, importantly, to be synergistic with fluconazole, whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo. Furthermore, candidaemia (bloodstream Candida infection) is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation
As previously mentioned, fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies, whereby the effect of fluconazole is enhanced by the addition of hLF1-11.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hLF1-11 | Experimental | Drug: hLF1-11hLF1-11 0.5mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo formulation is Similar to hLF1-11 iv formulation except for the active component |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained before admission in the study.
- Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.
- Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.
- Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
Key exclusion criteria (11 listed)
- Patients with a history of hypersensitivity to fluconazole or hLF1-11.
- Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.
- Patients with a history of fluconazole-resistant Candida species within 12 weeks.
- Neutropenic patients with neutrophil count below 0.5x10^9/L.
- Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
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 |
|---|---|---|
| hLF1-11The study treatment consists of IV administration of: (A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10 | Drug | hLF1-11 |
| hLF1-11Also: human lactoferrin 1-110.5mg hLF1-11 iv per day for 14 consecutive days | Drug | hLF1-11 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.
Time frame: 28 Days
1 secondary outcome
Test of Cure (TOC): Clinical: complete resolution of clinical signs and symptoms or resolution to a point where no further antifungal therapy is judged necessary; and Microbiological: eradication of Candida identified at baseline.
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 30 Jun 2015.
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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 hLF1-11 in people with Candidaemia, 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 4 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 30 Jun 2015. 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. Some participants in this study may receive a placebo. 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 30 Jun 2015.