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噬菌体疗法在铜绿假单胞菌定植的囊性纤维化受试者中的安全性和微生物活性的 1b/2 期试验

2026年6月18日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)

单剂量噬菌体疗法在铜绿假单胞菌定植的囊性纤维化受试者中的安全性和微生物活性的 1b/2 期、多中心、随机、双盲、安慰剂对照试验

这是一项 1b/2 期研究，在男性和未怀孕的女性中进行单剂量静脉内 (IV) 噬菌体，这些女性至少 18 岁，被诊断患有囊性纤维化 (CF)。 该临床试验旨在评估噬菌体产品 WRAIR_PAM-CF1 的安全性和微生物活性，该产品针对铜绿假单胞菌长期定植的临床稳定 CF 个体中的铜绿假单胞菌。 WRAIR_PAM-CF1 是一种包含 4 x 10^7 和 4 x 10^9 噬斑形成单位 (PFU) 的噬菌体的 4 组分抗假单胞菌噬菌体混合物。 注册将在美国多达 20 个临床地点进行。 在第 1 阶段，两名符合条件的受试者将被分配到三个给药组中的每一个，接受单次剂量的 IV 噬菌体治疗（4 x 10^7 PFU、4 x 10^8 PFU 和 4 x 10^9 PFU；总计6 名哨兵受试者），然后是 30 ± 7 天的观察期。 如果在第 1 阶段的所有哨兵受试者施用噬菌体后 96 小时内未发现 SAE（与研究产品相关），则研究将进入第 2 阶段。在第 2a 阶段，32 名受试者将被纳入 4 个组之一（安慰剂 IV、4 x 10^7 PFU、4 x 10^8 PFU 和 4 x 10^9 PFU）以 1:1:1:1 分配。 在所有受试者完成第 30 天的第 7 次随访后，将进行中期分析，以选择具有最有利安全性和微生物活性特征的 IV 噬菌体剂量。 在第 2b 阶段，受试者将被随机分配到噬菌体组（根据第 2a 阶段后的中期分析选择剂量）或安慰剂组。 最终样本量预计将达到总共 72 名受试者，其中安慰剂组最多 25 名受试者，2b 阶段噬菌体剂量最多 25 名受试者。

研究概览

地位

完全的

条件

干预/治疗

详细说明

这是一项 1b/2 期、多中心、随机安慰剂对照、双盲研究，研究对象为男性和未怀孕女性，年龄至少 18 岁，被诊断患有囊性纤维化 (CF)，单剂量静脉内 (IV) 噬菌体。 该临床试验旨在评估噬菌体产品 WRAIR_PAM-CF1 的安全性和微生物活性，该产品针对铜绿假单胞菌长期定植于临床稳定的 CF 个体中的铜绿假单胞菌。 WRAIR_PAM-CF1 是一种包含 4 x 10^7 和 4 x 10^9 噬斑形成单位 (PFU) 的噬菌体的 4 组分抗假单胞菌噬菌体混合物。 注册将在美国多达 20 个临床地点进行。 在第 1 阶段，两名前哨受试者将被分配到三个给药组中的每一个，接受单次剂量的 IV 噬菌体治疗（4 x 10^7 PFU、4 x 10^8 PFU 和 4 x 10^9 PFU；总计6 名哨兵受试者），然后是 30 ± 7 天的观察期。 如果在第 1 阶段的所有哨兵受试者施用噬菌体后 96 小时内未发现 SAE（与研究产品相关），则研究将进入第 2 阶段。在第 2a 阶段，32 名受试者将被纳入 4 个组之一（安慰剂 IV、4 x 10^7 PFU、4 x 10^8 PFU 和 4 x 10^9 PFU）以 1:1:1:1 分配。 在所有受试者完成第 30 天的第 7 次随访后，将进行中期分析，以选择具有最有利安全性和微生物活性特征的 IV 噬菌体剂量。 在第 2b 阶段，受试者将被随机分配到噬菌体组（根据第 2a 阶段后的中期分析选择剂量）或安慰剂组。 最终样本量预计将达到总共 72 名受试者，其中安慰剂组最多 25 名受试者，2b 阶段噬菌体剂量最多 25 名受试者。 本研究的主要目标是 1) 描述在临床稳定的 CF 受试者中使用单剂量 IV 噬菌体疗法治疗痰液中铜绿假单胞菌的安全性； 2) 描述在临床稳定的 CF 受试者中单剂量 IV 噬菌体治疗的微生物活性，其中咳出的痰中有铜绿假单胞菌； 3) 描述在临床稳定的 CF 受试者中咳出痰中铜绿假单胞菌的单剂量 IV 噬菌体治疗的风险收益比。

研究类型

介入性

注册 (实际的)

73

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Tucson、Arizona、美国、85724-0001
        • The University of Arizona - Banner University Medical Center Tucson Campus - Tucson
    • California
      • La Jolla、California、美国、92037
        • University of California, San Diego
      • La Jolla、California、美国、92121
        • University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)
      • Los Angeles、California、美国、90095
        • University of California Los Angeles Medical Center - Westwood Clinic
      • Sacramento、California、美国、95816
        • University of California Davis Health
      • Stanford、California、美国、94305
        • Stanford University
    • Connecticut
      • North Haven、Connecticut、美国、06473
        • Yale North Haven Medical Center- Winchester Center for Lung Disease
    • Florida
      • Tampa、Florida、美国、22612
        • University of South Florida/Tampa General Hospital
    • Georgia
      • Atlanta、Georgia、美国、30324
        • Emory University - Adult Cystic Fibrosis Program
    • Maryland
      • Baltimore、Maryland、美国、21205
        • Johns Hopkins University
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • Michigan Medicine
    • Minnesota
      • Minneapolis、Minnesota、美国、55455-0341
        • University of Minnesota Medical Center
    • New York
      • New Hyde Park、New York、美国、11050
        • Northwell Health
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
    • Ohio
      • Cleveland、Ohio、美国、44106
        • Case Western Reserve University
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas、Texas、美国、75390
        • University of Texas Southwestern Medical Center
      • Houston、Texas、美国、77030-3411
        • Baylor College of Medicine
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

受试者必须满足所有纳入标准才有资格参与研究：

  1. 筛选时的成人（>/= 18 岁）。

  2. 根据异常汗液氯化物测试或两个 CFTR 基因变异确认的相容临床综合征，确认 CF 诊断。 *

    *可从医疗记录文件中获得；不需要实际测试结果。

  3. 在高渗盐水处理或其他增加痰液产生的方法后，在 30 分钟的痰液收集过程中可能能够产生至少 2 mL 的痰液。 *

    **由研究者或其指定人员判断确定。 获取痰液的方法可能包括但不限于吸入高渗盐水（例如 3%、7% 或 10%）、吸入高渗碳酸氢盐、吸入甘露醇或自行咳出痰液。 相同的方法应该用于给定受试者的所有痰液收集。

  4. 在过去 12 个月内从痰液、咽喉培养物或其他呼吸道样本中分离出铜绿假单胞菌（不考虑菌落形成单位 (CFU)/mL）。
  5. 在筛查访视时从咳出的痰液样本中分离出确认的铜绿假单胞菌。
  6. 能够提供知情同意。
  7. 有能力并愿意完成所有研究访问并执行协议要求的所有程序。

排除标准：

符合任何排除标准的受试者将不会被纳入研究：

  1. 体重 < 30 公斤。
  2. 第 1 秒用力呼气量 < 筛选时预测值的 20%，使用 Hankinson 方程。

  3. 筛选时获得升高的 LFT。 *

    *一种。丙氨酸转氨酶 (ALT) > 5 x 正常上限 (ULN) 或天冬氨酸转氨酶 (AST) > 5 x ULN 或总胆红素 > 3 x ULN，或 b. 总胆红素 > 1.5 x ULN 结合 ALT > 3 x ULN 或 AST > 3 x ULN。 ULN 反映当地实验室范围。

  4. 需要新的（口服、肠胃外）或吸入抗生素的急性临床疾病

    *不包括慢性抑制药物或周期性给药药物，例如吸入抗生素。

  5. 怀孕、计划在研究期间怀孕或正在哺乳的女性。 * *育龄妇女必须在筛选期间进行血清 β-人绒毛膜促性腺激素试验阴性，并同意在试验期间使用有效的避孕方法。*

    *女性被认为具有生育潜力，除非绝经后或手术绝育并且自绝育程序后至少已过去 3 个月。

    1. 女性绝育手术包括输卵管结扎术、双侧输卵管切除术、子宫切除术或双侧卵巢切除术。
    2. 如果女性年龄 > 45 岁并且在没有其他已知或疑似原因的情况下至少 12 个月没有自然月经，则认为女性已绝经。
    3. 有效的避孕方法包括 (a) 禁欲，(b) 伴侣输精管切除术，(c) 宫内节育器，(d) 激素植入物（如 Implanon），或 (e) 其他激素方法（避孕药、注射剂、贴剂、阴道戒指）。
  6. 积极治疗任何分枝杆菌或真菌生物

  7. 预计在研究期间需要改变长期抗生素治疗方案。*

    *接受循环给药药物（如吸入抗生素）的受试者必须能够并表示愿意在随访期间保持筛选时的治疗不变（继续接受治疗或不接受治疗）（大约 30 天）。 接受慢性抑制性抗微生物治疗的受试者必须能够并表示愿意在随访期间继续接受治疗。 这包括慢性阿奇霉素治疗。

  8. 已知对研究产品的任何成分过敏。
  9. 研究者认为任何重大发现会使受试者参与本研究不安全。
  10. 参加了一项临床试验
  11. 当前或以前参加过此试验。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：第 2a 阶段第 1 组
25 毫升 0.9% 的氯化钠盐水溶液作为单剂量静脉内给药 30 分钟。 N=8
其他：安慰剂
0.9% 氯化钠
安慰剂比较：第 2b 阶段第 1 臂
25 毫升 0.9% 的氯化钠盐水溶液作为单剂量静脉内给药 30 分钟。 人数=17
其他：安慰剂
0.9% 氯化钠
有源比较器：第 1/2a 阶段第 2 臂
4x10^7 斑块形成​​单位 (PFU) 的 WRAIR-PAM-CF1 与约 25 mL 0.9% 氯化钠盐水溶液一起作为单次剂量静脉内给药 30 分钟。 第一阶段：N=2（前哨受试者）；第 2a 阶段：N=8
生物：WRAIR-PAM-CF1
由以下噬菌体组成的噬菌体组合：PaWRA01Phi11、PaWRA01Phi39、PaWRA02Phi83 和 PaWRA02Phi87。
有源比较器：第 1/2a 阶段第 3 臂
4x10^8 斑块形成​​单位 (PFU) 的 WRAIR-PAM-CF1 与约 25 mL 0.9% 氯化钠盐水溶液一起作为单次剂量静脉内给药 30 分钟。 第一阶段：N=2（前哨受试者）；第 2a 阶段：N=8
生物：WRAIR-PAM-CF1
由以下噬菌体组成的噬菌体组合：PaWRA01Phi11、PaWRA01Phi39、PaWRA02Phi83 和 PaWRA02Phi87。
有源比较器：第 1/2a 阶段第 4 臂
4x10^9 斑块形成​​单位 (PFU) 的 WRAIR-PAM-CF1 与约 25 mL 0.9% 氯化钠盐水溶液一起作为单次剂量静脉内给药 30 分钟。 第一阶段：N=2（前哨受试者）；第 2a 阶段：N=8
生物：WRAIR-PAM-CF1
由以下噬菌体组成的噬菌体组合：PaWRA01Phi11、PaWRA01Phi39、PaWRA02Phi83 和 PaWRA02Phi87。
有源比较器：2b 阶段第 2 臂
WRAIR-PAM-CF1 浓度在 2a 阶段后分析后确定，以 25 mL 0.9% 的氯化钠盐水溶液作为单剂量静脉内给药 30 分钟。 人数=17
生物：WRAIR-PAM-CF1
由以下噬菌体组成的噬菌体组合：PaWRA01Phi11、PaWRA01Phi39、PaWRA02Phi83 和 PaWRA02Phi87。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants That Experienced Grade 2 or Higher Treatment-emergent Adverse Events in the ITT Population
大体时间：Day 1 through Day 30
An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.
Day 1 through Day 30
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
大体时间：Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are substituted with the limit of detection (LOD) of the assay (1 x 10^4 CFU/mL).
Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
大体时间：Day 1 Post-infusion, Day 2, Day 5, and Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10^4 CFU/mL)
Day 1 Post-infusion, Day 2, Day 5, and Day 8
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
大体时间：Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are treated as missing.
Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
大体时间：Day 1 Post-infusion, Day 2, Day 5, and Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Day 1 Post-infusion, Day 2, Day 5, and Day 8
Number of Susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10^4 CFU/mL)
Baseline through Day 8
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).
Baseline through Day 8
Number of Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).
Baseline through Day 8
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).
Baseline through Day 8
Number of Susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8
Number of Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
大体时间：Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8

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赞助

National Institute of Allergy and Infectious Diseases (NIAID)

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年10月3日

初级完成 (实际的)

2025年4月10日

研究完成 (实际的)

2025年4月10日

研究注册日期

首次提交

2022年7月7日

首先提交符合 QC 标准的

2022年7月7日

首次发布 (实际的)

2022年7月12日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年6月18日

最后验证

2025年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20-0001
  • 2UM1AI104681-08 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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