LMN-201 C.ディフィシル感染症の再発予防
C.ディフィシル感染症の再発予防を目的としたLMN-201の第2相ランダム化二重盲検プラセボ対照試験
This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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California
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Escondido、California、アメリカ、90027
- Kaiser Permanente
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Connecticut
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Hamden、Connecticut、アメリカ、06518
- Gastroenterology Center of Connecticut
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Florida
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Tampa、Florida、アメリカ、33606
- University of South Florida
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Illinois
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Burr Ridge、Illinois、アメリカ、60527
- Metro Infectious Disease Consultants, LLC
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Kentucky
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Lexington、Kentucky、アメリカ、40503
- Baptist Health Research
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Health System
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic - Rochester
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New York
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New York、New York、アメリカ、10021
- Weill Cornell Medicine
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North Carolina
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Mount Airy、North Carolina、アメリカ、27030
- IMA Clinical Research
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Texas
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Houston、Texas、アメリカ、77030
- MD Anderson Cancer Center
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Virginia
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Annandale、Virginia、アメリカ、22003
- Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia School of Medicine
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Springfield、Virginia、アメリカ、22015
- Kaiser Permanente-Mid Atlantic
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- UW Health University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female, aged 18 or older.
- Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.
- Provision of signed and dated informed consent form.
- Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
- Ability to take oral medication and willingness to adhere to the study medication regimen.
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
- Access to a mobile smartphone.
- For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.
- For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.
Exclusion Criteria:
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Fulminant C. difficile colitis.
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Admitted or expect to be admitted to an intensive care unit.
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Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
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Neutropenia (absolute neutrophil count of < 1000 per microliter for any reason).
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Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:
- Bezlotoxumab (Zinplava, Merck & Co.), or another antibody against C. difficile toxin(s)
- C. difficile vaccine
- SER-109 (Seres Therapeutics)
- CP101 (Finch Therapeutics)
- VE303 (Vedanta Therapeutics)
- Fecal microbiota transplant
- Current therapy with oral exchange resins
- Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.)
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Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
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Pregnancy, anticipated pregnancy, or breastfeeding.
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Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
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Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine.
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Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
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Status as an inmate, residential mental health program, or residential substance abuse program.
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Terminal illness with limited life expectancy of less than 24 weeks.
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Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.
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Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of the study.
- Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.
- Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.
研究計画
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules. |
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実験的：センチネルコホート
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LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins:
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アクティブコンパレータ：LMN-201
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LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins:
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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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Proportion of participants who achieve global cure
時間枠：Up to 16 weeks after initiation of therapy
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Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment). |
Up to 16 weeks after initiation of therapy
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- CDI02
- CDMRP-PR221885 (その他の助成金/資金番号：CDMRP)
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?
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
米国FDA規制機器製品の研究
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