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Studio per valutare la sicurezza, la tollerabilità e l'efficacia dell'afabicina nel trattamento dei partecipanti con infezione ossea o articolare dovuta a stafilococco

7 settembre 2026 aggiornato da: Debiopharm International SA

Studio randomizzato in aperto con controllo attivo per valutare la sicurezza, la tollerabilità e l'efficacia dell'afabicina IV/orale nel trattamento di pazienti con infezione ossea o articolare dovuta a stafilococco

Questo è uno studio randomizzato, con controllo attivo, in aperto per valutare la sicurezza, la tollerabilità e l'efficacia di Afabicin nel trattamento di partecipanti con infezione ossea o articolare dovuta a Staphylococcus aureus [sia S. aureus meticillino-sensibile (MSSA) che meticillino aureus resistente (MRSA)] e/o stafilococchi coagulasi-negativi (CoNS) e confrontarlo con lo standard di cura (SOC).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

67

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Diagnosi di infezione ossea o articolare che soddisfi le seguenti condizioni: a) L'infezione è dovuta solo a S. aureus (MSSA o MRSA) e/o CoNS; e, b) I partecipanti non avevano ricevuto più di 7 giorni di antibiotici empirici prima di iniziare il trattamento con il farmaco in studio a meno che l'agente patogeno isolato non fosse resistente agli antibiotici empirici somministrati; e, c) il biofilm non è considerato ancora stabilito e/o è stato eradicato meccanicamente; e, d) l'infezione non è associata a un piede diabetico; e, e) L'infezione può coinvolgere il tessuto periostale o molle.

Criteri di esclusione:

  • Presenza di co-infezione con batteri non stafilococcici nell'articolazione o nel sito osseo interessato o nel sangue.
  • Partecipanti ad aumentato rischio di sviluppare danno epatico.
  • Shock circolatorio o qualsiasi condizione medica associata a rischio acuto di morte.
  • Aspettativa di vita inferiore a 1 anno.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Afabicina
Somministrato per via endovenosa e orale.
Sperimentale: 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.
Droga: Afabicina
Somministrato per via endovenosa e orale.
Comparatore attivo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.
Comparatore attivo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.
Sperimentale: 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.
Droga: Afabicina
Somministrato per via endovenosa e orale.
Sperimentale: 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.
Droga: Afabicina
Somministrato per via endovenosa e orale.
Comparatore attivo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.
Comparatore attivo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Clinical Response
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Debiopharm International SA

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 febbraio 2019

Completamento primario (Effettivo)

23 aprile 2025

Completamento dello studio (Effettivo)

23 aprile 2025

Date di iscrizione allo studio

Primo inviato

26 ottobre 2018

Primo inviato che soddisfa i criteri di controllo qualità

26 ottobre 2018

Primo Inserito (Effettivo)

29 ottobre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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