이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Staphylococcus로 인한 뼈 또는 관절 감염이 있는 참가자의 치료에서 Afabicin의 안전성, 내약성 및 효능을 평가하기 위한 연구

2026년 9월 7일 업데이트: Debiopharm International SA

Staphylococcus로 인한 뼈 또는 관절 감염 환자의 치료에서 Afabicin IV/Oral의 안전성, 내약성 및 효능을 평가하기 위한 무작위 공개 라벨 활성 대조 연구

이것은 Staphylococcus aureus[메티실린 감수성 S. 아우레우스(MSSA) 및 메티실린 모두 -내성 S. 아우레우스(MRSA)] 및/또는 응고효소 음성 포도상구균(CoNS) 및 표준 치료(SOC)와 비교합니다.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

67

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 다음 조건을 충족하는 뼈 또는 관절 감염의 진단: a) 감염은 S. 아우레우스(MSSA 또는 MRSA) 및/또는 CoNS에만 기인합니다. b) 참가자는 분리된 병원체가 투여된 경험적 항생제에 내성이 없는 한 연구 약물로 치료를 시작하기 전에 경험적 항생제를 7일 이상 받지 않았습니다. c) 생물막이 아직 확립되지 않았거나 기계적으로 박멸된 것으로 간주됩니다. 및, d) 감염이 당뇨병성 발과 관련되지 않음; e) 감염은 골막 또는 연조직을 포함할 수 있습니다.

제외 기준:

  • 영향을 받은 관절이나 뼈 부위 또는 혈액에 비포도상구균 박테리아와의 공동 감염이 존재합니다.
  • 간 손상이 발생할 위험이 높은 참가자.
  • 순환 쇼크 또는 급성 사망 위험과 관련된 모든 의학적 상태.
  • 기대 수명은 1년 미만입니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 아파비신
정맥 주사 및 경구 투여.
실험적: 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.
의약품: 아파비신
정맥 주사 및 경구 투여.
활성 비교기: 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.
의약품: Cefazolin
Administered intravenously.
의약품: Vancomycin
Administered intravenously.
의약품: Linezolid
Administered intravenously and orally.
의약품: Clindamycin
Administered intravenously and orally.
활성 비교기: 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.
의약품: Cefazolin
Administered intravenously.
의약품: Vancomycin
Administered intravenously.
의약품: Linezolid
Administered intravenously and orally.
의약품: Clindamycin
Administered intravenously and orally.
실험적: 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.
의약품: 아파비신
정맥 주사 및 경구 투여.
실험적: 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.
의약품: 아파비신
정맥 주사 및 경구 투여.
활성 비교기: 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.
의약품: Cefazolin
Administered intravenously.
의약품: Vancomycin
Administered intravenously.
의약품: Linezolid
Administered intravenously and orally.
의약품: Clindamycin
Administered intravenously and orally.
활성 비교기: 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.
의약품: Cefazolin
Administered intravenously.
의약품: Vancomycin
Administered intravenously.
의약품: Linezolid
Administered intravenously and orally.
의약품: Clindamycin
Administered intravenously and orally.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Clinical Response
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Debiopharm International SA

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 20일

기본 완료 (실제)

2025년 4월 23일

연구 완료 (실제)

2025년 4월 23일

연구 등록 날짜

최초 제출

2018년 10월 26일

QC 기준을 충족하는 최초 제출

2018년 10월 26일

처음 게시됨 (실제)

2018년 10월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 7일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다