drugset / Trial / NCT07228702
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
NaSingle-groupOpen-labelTreatment
Summary
This study aims to use mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy\_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with Mycobacterium abscessus with goal to reduce infection burden and improve pulmonary disease
Timeline
- Start
- 2026-01-11
- Primary completion
- 2027-10
- Completion
- 2027-10
Publications
- Background Reindel R, Fiore CR. Phage Therapy: Considerations and Challenges for Development. Clin Infect Dis. 2017 Jun 1;64(11):1589-1590. doi: 10.1093/cid/cix188. No abstract available.
- Background Hatfull GF. Phage Therapy for Nontuberculous Mycobacteria: Challenges and Opportunities. Pulm Ther. 2023 Mar;9(1):91-107. doi: 10.1007/s41030-022-00210-y. Epub 2022 Dec 30.
- Background Dedrick RM, Smith BE, Cristinziano M, Freeman KG, Jacobs-Sera D, Belessis Y, Whitney Brown A, Cohen KA, Davidson RM, van Duin D, Gainey A, Garcia CB, Robert George CR, Haidar G, Ip W, Iredell J, Khatami A, Little JS, Malmivaara K, McMullan BJ, Michalik DE, Moscatelli A, Nick JA, Tupayachi Ortiz MG, Polenakovik HM, Robinson PD, Skurnik M, Solomon DA, Soothill J, Spencer H, Wark P, Worth A, Schooley RT, Benson CA, Hatfull GF. Phage Therapy of Mycobacterium Infections: Compassionate Use of Phages in 20 Patients With Drug-Resistant Mycobacterial Disease. Clin Infect Dis. 2023 Jan 6;76(1):103-112. doi: 10.1093/cid/ciac453.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycobacteriophage Muddy_HRMN0052 | Other / unclassified | 1 ml | Intravenous |
| Background | Amikacin | Small molecule | 1000 mg | Intravenous |
| Background | Bedaquiline | Small molecule | 200 mg | Oral |
| Background | Ceftaroline | Other / unclassified | 600 mg | Intravenous |
| Background | Cilastatin | Small molecule | — | — |
| Background | Clofazimine | Small molecule | 100 mg | Oral |
| Background | IMIPENEM ANHYDROUS | Small molecule | 1 g | Intravenous |
| Background | Linezolid | Other / unclassified | 600 mg | Oral |
| Background | Omadacycline | Small molecule | 300 mg | Oral |
| Background | Sulfamethoxazole | Small molecule | 800 mg | Oral |
| Background | Trimethoprim | Small molecule | 160 mg | Oral |