A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia (SLIC)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Candidaemia |
Drug: hLF1-11 Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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) |
- Haematology, biochemistry, and microbiological evaluation Adverse event monitoring. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: hLF1-11
hLF1-11 0.5mg
|
Drug: hLF1-11
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 Other Name: hLF1-11
Drug: hLF1-11
0.5mg hLF1-11 iv per day for 14 consecutive days
Other Name: human lactoferrin 1-11
|
|
Placebo Comparator: 2
Similar to hLF1-11 iv formulation except for the active component
|
Drug: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations| Netherlands | |
| UMC St. Radboud | |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Principal Investigator: | Professor P.E. Verweij, MD, PhD | UMC St. Radboud, Nijmegen, The Netherlands |
More Information
No publications provided
| Responsible Party: | Dr J Arend, MD, AM-Pharma |
| ClinicalTrials.gov Identifier: | NCT00509834 History of Changes |
| Other Study ID Numbers: | AMP IC 01-01 |
| Study First Received: | July 31, 2007 |
| Last Updated: | October 16, 2008 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by AM-Pharma:
|
hLF1-11 Candida candidaemia lactoferrin |
Additional relevant MeSH terms:
|
Candidemia Fungemia Sepsis Infection Candidiasis, Invasive |
Candidiasis Mycoses Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013