A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia (SLIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509834
Recruitment Status : Withdrawn (Patient population not available)
First Posted : August 1, 2007
Last Update Posted : June 30, 2015
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Candidaemia Drug: hLF1-11 Drug: Placebo Phase 1 Phase 2

Detailed Description:


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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : July 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2009

Arm Intervention/treatment
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

Drug: hLF1-11
0.5mg hLF1-11 iv per day for 14 consecutive days
Other Name: human lactoferrin 1-11

Placebo Comparator: Placebo
Placebo formulation is Similar to hLF1-11 iv formulation except for the active component
Drug: Placebo

Primary Outcome Measures :
  1. Haematology, biochemistry, and microbiological evaluation Adverse event monitoring. [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  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. [ Time Frame: 28 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509834

UMC St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Principal Investigator: Professor P.E. Verweij, MD, PhD UMC St. Radboud, Nijmegen, The Netherlands

Responsible Party: AM-Pharma Identifier: NCT00509834     History of Changes
Other Study ID Numbers: AMP IC 01-01
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: April 2008

Keywords provided by AM-Pharma:

Additional relevant MeSH terms:
Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Infective Agents