Effect of Co-trimoxazole (Trimethoprim-Sulfamethoxazole) vs Placebo on Death, Lung Transplant, or Hospital Admission in Patients With Moderate and Severe Idiopathic Pulmonary Fibrosis: The EME-TIPAC Randomized Clinical Trial

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Main idea: Among patients with moderate or severe IPF, treatment with oral co-trimoxazole did not reduce a composite outcome of time to death, transplant, or nonelective hospitalization compared with placebo.

Abstract

Idiopathic pulmonary fibrosis (IPF) has a poor prognosis and limited treatment options. Patients with IPF have altered lung microbiota, with bacterial burden within the lungs associated with mortality. Previous studies have suggested the benefit of co-trimoxazole.

The objective of the study was to determine the efficacy of co-trimoxazole in patients with moderate and severe idiopathic pulmonary fibrosis.

Double-blind, placebo-controlled, parallel randomized trial of 342 patients with idiopathic pulmonary fibrosis, breathlessness, and impaired lung function conducted in 39 UK specialist interstitial lung disease centers between April 2015 and April 2019.

Study participants were randomized to receive 960 mg of oral co-trimoxazole twice daily or matched placebo.

Among 342 individuals who were randomized, 283 (83%) completed the trial. There were no statistically significant differences in other event outcomes, lung function, or patient-reported outcomes. Patients in the co-trimoxazole group had 696 adverse events and patients in the placebo group had 640 adverse events. The median duration of follow-up was 1.02 years. Events per person-year of follow-up were 0.45 and 0.38 with a hazard ratio of 1.2.

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