Studie zur Bewertung der Sicherheit, Verträglichkeit und Wirksamkeit von Afabicin bei der Behandlung von Teilnehmern mit Knochen- oder Gelenkinfektionen aufgrund von Staphylokokken
7. September 2026 aktualisiert von: Debiopharm International SA
Randomisierte, offene, aktiv kontrollierte Studie zur Bewertung der Sicherheit, Verträglichkeit und Wirksamkeit von Afabicin IV/Oral bei der Behandlung von Patienten mit Knochen- oder Gelenkinfektionen aufgrund von Staphylokokken
Dies ist eine randomisierte, aktiv kontrollierte, unverblindete Studie zur Bewertung der Sicherheit, Verträglichkeit und Wirksamkeit von Afabicin bei der Behandlung von Teilnehmern mit Knochen- oder Gelenkinfektionen aufgrund von Staphylococcus aureus [sowohl Methicillin-empfindlicher S. aureus (MSSA) als auch Methicillin -resistenter S. aureus (MRSA)] und/oder Koagulase-negative Staphylokokken (CoNS) und zum Vergleich mit dem Behandlungsstandard (SOC).
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
67
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Akhalts'ikhe, Georgia, 0800
- Georgian Clinics JSC
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Kutaisi, Georgia, 4600
- West Georgia Medical Center LLC
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Tbilisi, Georgia, 0141
- LEPL The First University Clinic of Tbilisi State Medical University
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Tbilisi, Georgia, 0144
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
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Tbilisi, Georgia, 0101
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
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Tbilisi, Georgia, 0160
- Academician Vakhtang Bochorishvili Clinic LTD
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Tbilisi, Georgia, 0186
- Caucasus Medical Center LLC
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Benoni, Südafrika, 1500
- Worthwhile Clinical Trials, Lakeview Hospital
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Pretoria, Südafrika, 0002
- Clinical Research Unit, University of Pretoria
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Pretoria, Südafrika, 0157
- Global Clinical Trials (Pty) Ltd
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Dnipro, Ukraine, 49027
- Dnipropetrovsk Regional Clinical Hospital
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Ivano-Frankivsk, Ukraine, 76008
- Regional Clinical Hospital under Ivano-Frankivsk Regional Council
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Kharkiv, Ukraine, 61176
- Kharkiv Regional Clinical Traumatology Hospital
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Kyiv, Ukraine, 04107
- Kyiv Regional Clinical Hospital
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Kyiv, Ukraine, 01601
- Institute of Traumatology and Orthopedics
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Kyiv, Ukraine
- Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
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Vinnytsia, Ukraine, 21028
- Vinnytsya Regional Clinical Hospital
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Vynnyky, Ukraine, 79495
- Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
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Zaporizhia, Ukraine, 69065
- City Hospital #9 under Zaporizhia City Council
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Einschlusskriterien:
- Diagnose einer Knochen- oder Gelenkinfektion, die die folgenden Bedingungen erfüllt: a) Die Infektion ist nur auf S. aureus (MSSA oder MRSA) und/oder CoNS zurückzuführen; und b) die Teilnehmer hatten nicht mehr als 7 Tage empirische Antibiotika vor Beginn der Behandlung mit dem Studienmedikament erhalten, es sei denn, der isolierte Erreger war gegen die verabreichten empirischen Antibiotika resistent; und c) Biofilm gilt als noch nicht etabliert und/oder wurde mechanisch beseitigt; und d) die Infektion nicht mit einem diabetischen Fuß assoziiert ist; und e) Infektion kann Periost- oder Weichgewebe betreffen.
Ausschlusskriterien:
- Vorhandensein einer Co-Infektion mit Nicht-Staphylokokken-Bakterien an der betroffenen Gelenk- oder Knochenstelle oder im Blut.
- Teilnehmer mit erhöhtem Risiko, eine Leberschädigung zu entwickeln.
- Kreislaufschock oder ein medizinischer Zustand, der mit einem akuten Todesrisiko verbunden ist.
- Lebenserwartung von weniger als 1 Jahr.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
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Intravenös und oral verabreicht.
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Experimental: 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.
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Intravenös und oral verabreicht.
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Aktiver 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.
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Administered intravenously.
Administered intravenously.
Administered intravenously and orally.
Administered intravenously and orally.
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Aktiver 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.
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Administered intravenously.
Administered intravenously.
Administered intravenously and orally.
Administered intravenously and orally.
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Experimental: 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.
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Intravenös und oral verabreicht.
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Experimental: 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.
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Intravenös und oral verabreicht.
|
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Aktiver 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.
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Administered intravenously.
Administered intravenously.
Administered intravenously and orally.
Administered intravenously and orally.
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Aktiver 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.
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Administered intravenously.
Administered intravenously.
Administered intravenously and orally.
Administered intravenously and orally.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Zeitfenster: Up to Day 142
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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.
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Up to Day 142
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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
Zeitfenster: Up to Day 142
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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.
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Up to Day 142
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Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters Based on NCI-CTCAE v4.03
Zeitfenster: Up to Day 142
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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.
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Up to Day 142
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Number of Participants With Grade Shift From Baseline in Electrolyte Parameters Based on NCI-CTCAE v4.03
Zeitfenster: Up to Day 142
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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.
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Up to Day 142
|
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Number of Participants With Grade Shift From Baseline in Coagulation Parameters Based on NCI-CTCAE v4.03
Zeitfenster: Up to Day 142
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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.
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Up to Day 142
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Number of Participants With Post-baseline Clinically Significant Urinalysis Abnormalities
Zeitfenster: Up to Day 142
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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.
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Up to Day 142
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants With Clinical Response
Zeitfenster: 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)
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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.
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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)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. Februar 2019
Primärer Abschluss (Tatsächlich)
23. April 2025
Studienabschluss (Tatsächlich)
23. April 2025
Studienanmeldedaten
Zuerst eingereicht
26. Oktober 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Oktober 2018
Zuerst gepostet (Tatsächlich)
29. Oktober 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Bewegungsapparates
- Pathologische Prozesse
- Krankheitsattribute
- Arthritis
- Gelenkerkrankungen
- Infektionen
- Übertragbare Krankheiten
- Arthritis, ansteckend
- Peptide
- Aminosäuren, Peptide und Proteine
- Schwefelverbindungen
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Azolen
- Kohlenhydrate
- Säuren, acyclisch
- Carboxylsäuren
- Glykoside
- Amides
- Glykoconjugate
- Pyrrolidine
- Lincomycin
- Lincosamides
- Beta-Lactams
- Lactams
- Cephalosporine
- Thiazinen
- Acetamides
- Acetate
- Oxazolidinone
- Oxazoles
- Glycopeptide
- Linezolid
- Vancomycin
- Cefazolin
- Clindamycin
- AFABICIN
Andere Studien-ID-Nummern
- Debio 1450-BJI-205
- 2017-002854-35 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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