- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00509834
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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Gelderland
-
Nijmegen, Gelderland, Nederland, 6500 HB
- UMC St. Radboud
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: hLF1-11
hLF1-11 0.5mg
|
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
Andre navn:
|
Placebo komparator: Placebo
Placebo formulation is Similar to hLF1-11 iv formulation except for the active component
|
Placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.
Tidsramme: 28 Days
|
28 Days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: 28 Days
|
28 Days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AMP IC 01-01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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