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Undersøgelse for at vurdere sikkerhed, tolerabilitet og effektivitet af afabicin i behandlingen af ​​deltagere med knogle- eller ledinfektion på grund af stafylokokker

7. september 2026 opdateret af: Debiopharm International SA

Randomiseret åbent, aktivt kontrolleret studie for at vurdere sikkerheden, tolerabiliteten og effektiviteten af ​​Afabicin IV/Oral i behandlingen af ​​patienter med knogle- eller ledinfektioner på grund af stafylokokker

Dette er et randomiseret, aktivt kontrolleret, åbent studie for at vurdere sikkerheden, tolerabiliteten og effektiviteten af ​​Afabicin i behandlingen af ​​deltagere med knogle- eller ledinfektioner på grund af Staphylococcus aureus [både methicillin-modtagelig S. aureus (MSSA) og methicillin -resistente S. aureus (MRSA)] og/eller koagulase-negative stafylokokker (CoNS) og sammenligne det med standardbehandling (SOC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Georgien
      • Akhalts'ikhe, Georgien, 0800
        • Georgian Clinics JSC
      • Kutaisi, Georgien, 4600
        • West Georgia Medical Center LLC
      • Tbilisi, Georgien, 0141
        • LEPL The First University Clinic of Tbilisi State Medical University
      • Tbilisi, Georgien, 0144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
      • Tbilisi, Georgien, 0101
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
      • Tbilisi, Georgien, 0160
        • Academician Vakhtang Bochorishvili Clinic LTD
      • Tbilisi, Georgien, 0186
        • Caucasus Medical Center LLC
  • Sydafrika
      • Benoni, Sydafrika, 1500
        • Worthwhile Clinical Trials, Lakeview Hospital
      • Pretoria, Sydafrika, 0002
        • Clinical Research Unit, University of Pretoria
      • Pretoria, Sydafrika, 0157
        • Global Clinical Trials (Pty) Ltd
  • Ukraine
      • Dnipro, Ukraine, 49027
        • Dnipropetrovsk Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine, 76008
        • Regional Clinical Hospital under Ivano-Frankivsk Regional Council
      • Kharkiv, Ukraine, 61176
        • Kharkiv Regional Clinical Traumatology Hospital
      • Kyiv, Ukraine, 04107
        • Kyiv Regional Clinical Hospital
      • Kyiv, Ukraine, 01601
        • Institute of Traumatology and Orthopedics
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
      • Vinnytsia, Ukraine, 21028
        • Vinnytsya Regional Clinical Hospital
      • Vynnyky, Ukraine, 79495
        • Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
      • Zaporizhia, Ukraine, 69065
        • City Hospital #9 under Zaporizhia City Council

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnose af knogle- eller ledinfektion, som opfylder følgende betingelser: a) Infektion skyldes kun S. aureus (MSSA eller MRSA) og/eller ConNS; og b) Deltagerne havde ikke modtaget mere end 7 dages empirisk antibiotika før påbegyndelse af behandling med undersøgelseslægemiddel, medmindre det isolerede patogen var resistent over for de administrerede empiriske antibiotika; og c) Biofilm anses ikke for at være etableret endnu og/eller er blevet mekanisk udryddet; og, d) Infektion er ikke forbundet med en diabetisk fod; og e) Infektion kan involvere periostealt eller blødt væv.

Ekskluderingskriterier:

  • Tilstedeværelse af samtidig infektion med ikke-stafylokokbakterier ved det berørte led eller knoglested eller i blodet.
  • Deltagere med øget risiko for at udvikle leverskade.
  • Cirkulationschok eller enhver medicinsk tilstand forbundet med akut risiko for død.
  • Forventet levetid på mindre end 1 år.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A: Afabicin: Cohort 1
Participants received afabicin intravenously (IV) at a dose of 160 milligrams (mg), twice daily (BID), followed by a switch to oral afabicin at a dose of 240 mg, BID, for 2-3 weeks.
Medicin: Afabicin
Indgives intravenøst ​​og oralt.
Eksperimentel: Part A: Afabicin: Cohort 2
Participants received afabicin IV at a dose of 160 mg, BID, followed by a switch to oral afabicin at a dose of 240 mg, BID, for 3-6 weeks.
Medicin: Afabicin
Indgives intravenøst ​​og oralt.
Aktiv komparator: Part A: SoC: Cohort 1
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicin: Cefazolin
Administered intravenously.
Medicin: Vancomycin
Administered intravenously.
Medicin: Linezolid
Administered intravenously and orally.
Medicin: Clindamycin
Administered intravenously and orally.
Aktiv komparator: Part A: SoC: Cohort 2
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicin: Cefazolin
Administered intravenously.
Medicin: Vancomycin
Administered intravenously.
Medicin: Linezolid
Administered intravenously and orally.
Medicin: Clindamycin
Administered intravenously and orally.
Eksperimentel: Part B: Afabicin: Cohort 1
Participants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 2-3 weeks.
Medicin: Afabicin
Indgives intravenøst ​​og oralt.
Eksperimentel: Part B: Afabicin: Cohort 2
Participants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 3-6 weeks.
Medicin: Afabicin
Indgives intravenøst ​​og oralt.
Aktiv komparator: Part B: SoC: Cohort 1
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicin: Cefazolin
Administered intravenously.
Medicin: Vancomycin
Administered intravenously.
Medicin: Linezolid
Administered intravenously and orally.
Medicin: Clindamycin
Administered intravenously and orally.
Aktiv komparator: Part B: SoC: Cohort 2
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicin: Cefazolin
Administered intravenously.
Medicin: Vancomycin
Administered intravenously.
Medicin: Linezolid
Administered intravenously and orally.
Medicin: Clindamycin
Administered intravenously and orally.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to Day 142
Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. TEAE is any undesirable event either not present prior to medical treatment or worsening (in intensity or frequency) following treatment. SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening (i.e., puts the patient at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Hematology Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03
Tidsramme: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters Based on NCI-CTCAE v4.03
Tidsramme: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Electrolyte Parameters Based on NCI-CTCAE v4.03
Tidsramme: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Coagulation Parameters Based on NCI-CTCAE v4.03
Tidsramme: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Post-baseline Clinically Significant Urinalysis Abnormalities
Tidsramme: Up to Day 142
Clinical significance of abnormalities in urinalysis was determined based on the investigator's discretion. Baseline is defined as the last assessment prior to the randomization.
Up to Day 142

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Clinical Response
Tidsramme: Part A: At Day 8, EOT (up to Day 22), 4-weeks post-EOT (up to Day 50), and 12-weeks post-EOT (up to Day 130); Part B: At Day 8, Day 28, Day 42, EOT (up to Day 43), 4-weeks post-EOT (up to Day 73), and 12-weeks post-EOT (up to Day 142)
Clinical response was based on the improvement of disease-specific signs and symptoms. Responders are defined as participants meeting all the following criteria: improvement of disease-specific signs and symptoms and no new signs, symptoms or complications attributable to the initial infection; No evidence of drainage, sinus tract formation or infection-related bone instability; No requirement for subsequent antibiotics with activity against Staphylococcus to treat the initial infection after the start of study treatment; Microbiological eradication of the baseline pathogen (if post-baseline sample[s] are available); Imaging test at 12 weeks post-EOT showing no worsening of baseline pathology or presence of signs indicating resolution or healing of the infection. Percentages are rounded off.
Part A: At Day 8, EOT (up to Day 22), 4-weeks post-EOT (up to Day 50), and 12-weeks post-EOT (up to Day 130); Part B: At Day 8, Day 28, Day 42, EOT (up to Day 43), 4-weeks post-EOT (up to Day 73), and 12-weeks post-EOT (up to Day 142)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Debiopharm International SA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. februar 2019

Primær færdiggørelse (Faktiske)

23. april 2025

Studieafslutning (Faktiske)

23. april 2025

Datoer for studieregistrering

Først indsendt

26. oktober 2018

Først indsendt, der opfyldte QC-kriterier

26. oktober 2018

Først opslået (Faktiske)

29. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Debio 1450-BJI-205
  • 2017-002854-35 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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