While infection or abnormal microbial colonisation may be a factor in worsening idiopathic pulmonary fibrosis (IPF), antibiotic treatment does not appear to help.
The addition of antimicrobial therapy to usual care in patients with IPF did not improve time to nonelective respiratory hospitalisation or death, a US study shows.
An RCT randomised 513 patients to one of three arms – either co-trimoxazole plus usual care, doxycycline plus usual care, or usual care alone.
Patients were mostly men (76.4%) with a median age 71 years and the majority (91%) were taking concurrent antifibrotic medications.
The study, published in JAMA, found the primary end point of death or first nonelective respiratory hospitalisation was 20.5% with antimicrobial therapy versus 21.6% with usual care alone (HR 1.04).
There was also no statistically significant difference between the groups in the individual events – death (13.5 v 11.5 per 100 patient-years; HR, 1.11) or first nonelective respiratory hospitalisation (14.1 v 10.2 per 100 patient-years; HR, 1.34).
Similarly there was no statistically significant difference in rates of nonelective all-cause hospitalisation (22.6 v 15.8 per 100 patient-years; HR 1.36).
The study found there were more respiratory serious adverse events (AEs) in patients treated with antimicrobial therapy including expected differences in prespecified AEs of special interest such as diarrhoea, vomiting, rash, arrhythmias, and hyperkalaemia.
The study was terminated early for futility after the first planned efficacy analysis.
“These findings do not support treatment with these antibiotics for the underlying disease,” the study authors said.
The US investigators said their findings were consistent with the EME-TIPAC study which found co-trimoxazole did not reduce a composite outcome of time to death, transplant, or nonelective hospitalisation in patients with moderate or severe IPF.
However the current study could not exclude that antimicrobials may work in select subsets of patients with IPF experiencing increased dysbiosis.
“Other approaches for manipulation of the microbiome from faecal transplant, phage therapy, or selective immunisation, among others, may prove successful,” they said.