drugset / Trial / NCT02759120
CleanUP IPF for the Pulmonary Trials Cooperative
Phase 3
Terminated
513 enrolled
Weill Medical College of Cornell University
Duke Clinical Research Institute · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabUniversity of Chicago · collabUniversity of Pittsburgh · collabUniversity of Washington · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
Timeline
- Start
- 2017-03-22
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
Outcome
Missed primary endpoint
Stopped: “Terminated for futility after review of first planned interim analysis.”
registry analysis (superiority test); Standard of Care; p = 0.83; Hazard Ratio (HR) 1.04 (95% CI 0.71 to 1.53); Regression, Cox NCT02759120 ↗
paper did not significantly improve time to nonelective respiratory hospitalization or death. PMID 33974018 ↗
Publications
- Kim JS, Murray S, Yow E, Anstrom KJ, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post Hoc Analysis of the CleanUP-IPF Study. Chest. 2024 May;165(5):1163-1173. doi: 10.1016/j.chest.2023.11.035. Epub 2023 Nov 27.
- Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT, Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I; CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1841-1851. doi: 10.1001/jama.2021.4956.
- Anstrom KJ, Noth I, Flaherty KR, Edwards RH, Albright J, Baucom A, Brooks M, Clark AB, Clausen ES, Durheim MT, Kim DY, Kirchner J, Oldham JM, Snyder LD, Wilson AM, Wisniewski SR, Yow E, Martinez FJ; CleanUP-IPF Study Team. Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial. Respir Res. 2020 Mar 12;21(1):68. doi: 10.1186/s12931-020-1326-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxycycline | Small molecule | 100 mg | — |
| Subject | Sulfamethoxazole | Small molecule | 800 mg | — |
| Subject | Trimethoprim | Small molecule | 160 mg | — |
| Background | folic acid | Other / unclassified | 5 mg | — |