A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia (SLIC)
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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
-
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Gelderland
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Nijmegen, Gelderland, Olanda, 6500 HB
- UMC St. Radboud
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: hLF1-11
hLF1-11 0.5mg
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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
0.5mg hLF1-11 iv per day for 14 consecutive days
Altri nomi:
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Comparatore placebo: Placebo
Placebo formulation is Similar to hLF1-11 iv formulation except for the active component
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Placebo
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.
Lasso di tempo: 28 Days
|
28 Days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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.
Lasso di tempo: 28 Days
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28 Days
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AMP IC 01-01
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