ブドウ球菌による骨または関節感染症の参加者の治療におけるアファビシンの安全性、忍容性および有効性を評価するための研究
2026年9月7日 更新者：Debiopharm International SA
ブドウ球菌による骨または関節感染症の患者の治療におけるアファビシン IV/経口の安全性、忍容性、および有効性を評価するための無作為化非盲検実薬対照試験
これは、黄色ブドウ球菌 [メチシリン感受性黄色ブドウ球菌 (MSSA) およびメチシリン耐性黄色ブドウ球菌 (MRSA)] および/またはコアグラーゼ陰性ブドウ球菌 (CoNS) と比較し、それを標準治療 (SOC) と比較します。
調査の概要
研究の種類
介入
入学 (実際)
67
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Dnipro、ウクライナ、49027
- Dnipropetrovsk Regional Clinical Hospital
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Ivano-Frankivsk、ウクライナ、76008
- Regional Clinical Hospital under Ivano-Frankivsk Regional Council
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Kharkiv、ウクライナ、61176
- Kharkiv Regional Clinical Traumatology Hospital
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Kyiv、ウクライナ、04107
- Kyiv Regional Clinical Hospital
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Kyiv、ウクライナ、01601
- Institute of Traumatology and Orthopedics
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Kyiv、ウクライナ
- Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
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Vinnytsia、ウクライナ、21028
- Vinnytsya Regional Clinical Hospital
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Vynnyky、ウクライナ、79495
- Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
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Zaporizhia、ウクライナ、69065
- City Hospital #9 under Zaporizhia City Council
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Akhalts'ikhe、グルジア、0800
- Georgian Clinics JSC
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Kutaisi、グルジア、4600
- West Georgia Medical Center LLC
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Tbilisi、グルジア、0141
- LEPL The First University Clinic of Tbilisi State Medical University
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Tbilisi、グルジア、0144
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
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Tbilisi、グルジア、0101
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
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Tbilisi、グルジア、0160
- Academician Vakhtang Bochorishvili Clinic LTD
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Tbilisi、グルジア、0186
- Caucasus Medical Center LLC
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Benoni、南アフリカ、1500
- Worthwhile Clinical Trials, Lakeview Hospital
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Pretoria、南アフリカ、0002
- Clinical Research Unit, University of Pretoria
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Pretoria、南アフリカ、0157
- Global Clinical Trials (Pty) Ltd
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 以下の条件を満たす骨または関節の感染症の診断: a) 黄色ブドウ球菌 (MSSA または MRSA) および/または CoNS のみによる感染症; b) 参加者は、分離された病原体が投与された経験的抗生物質に耐性でない限り、治験薬による治療を開始する前に経験的抗生物質を7日以上受けていませんでした。 c) バイオフィルムは、まだ確立されていない、および/または機械的に根絶されたとは見なされません。 d) 感染症は糖尿病性足に関連していません。 e) 感染は、骨膜または軟部組織に関与する可能性があります。
除外基準:
- 影響を受けた関節または骨部位、または血液中の非ブドウ球菌による同時感染の存在。
- 肝障害を発症するリスクが高い参加者。
- 循環ショックまたは死亡の急性リスクに関連する病状。
- 平均余命は1年未満。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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静脈内および経口で投与されます。
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実験的：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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静脈内および経口で投与されます。
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アクティブコンパレータ：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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アクティブコンパレータ：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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実験的：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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静脈内および経口で投与されます。
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実験的：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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静脈内および経口で投与されます。
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アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Clinical Response
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年2月20日
一次修了 (実際)
2025年4月23日
研究の完了 (実際)
2025年4月23日
試験登録日
最初に提出
2018年10月26日
QC基準を満たした最初の提出物
2018年10月26日
最初の投稿 (実際)
2018年10月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Debio 1450-BJI-205
- 2017-002854-35 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。