IMPORTANCE Alteration in lung microbes is associated with disease progression in idiopathic pulmonary fibrosis. OBJECTIVE To assess the effect of antimicrobial therapy on clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS Pragmatic, randomized, unblinded clinical trial conducted across 35 US sites. A total of 513 patients older than 40 years were randomized from August 2017 to June 2019 (final follow-up was January 2020).INTERVENTIONS Patients were randomized in a 1:1 allocation ratio to receive antimicrobials (n = 254) or usual care alone (n = 259). Antimicrobials included co-trimoxazole (trimethoprim 160 mg/sulfamethoxazole 800 mg twice daily plus folic acid 5 mg daily, n = 128) or doxycycline (100 mg once daily if body weight <50 kg or 100 mg twice daily if Ն50 kg, n = 126). No placebo was administered in the usual care alone group.
MAIN OUTCOMES AND MEASURESThe primary end point was time to first nonelective respiratory hospitalization or all-cause mortality. RESULTS Among the 513 patients who were randomized (mean age, 71 years; 23.6% women), all (100%) were included in the analysis. The study was terminated for futility on December 18, 2019. After a mean follow-up time of 13.1 months (median, 12.7 months), a total of 108 primary end point events occurred: 52 events (20.4 events per 100 patient-years [95% CI, 14.8-25.9]) in the usual care plus antimicrobial therapy group and 56 events (18.4 events per 100 patient-years [95% CI, 13.2-23.6]) in the usual care group, with no significant difference between groups (adjusted HR, 1.04 [95% CI, 0.71-1.53; P = .83]. There was no statistically significant interaction between the effect of the prespecified antimicrobial agent (co-trimoxazole vs doxycycline) on the primary end point (adjusted HR, 1.15 [95% CI 0.68-1.95] in the co-trimoxazole group vs 0.82 [95% CI, 0.46-1.47] in the doxycycline group; P = .66). Serious adverse events occurring at 5% or greater among those treated with usual care plus antimicrobials vs usual care alone included respiratory events (16.5% vs 10.0%) and infections (2.8% vs 6.6%); adverse events of special interest included diarrhea (10.2% vs 3.1%) and rash (6.7% vs 0%).CONCLUSIONS AND RELEVANCE Among adults with idiopathic pulmonary fibrosis, the addition of co-trimoxazole or doxycycline to usual care, compared with usual care alone, did not significantly improve time to nonelective respiratory hospitalization or death. These findings do not support treatment with these antibiotics for the underlying disease.
The length of a course of antibiotic treatment for urinary tract infection varies with the habits of the prescriber. Many patients do not complete a course of treatment once their symptoms have subsided. In uncomplicated urinary tract infection among women seen in general practice a three-day course of amoxycillin was as effective as a 10-day course of the same drug in the same dose. Relief of symptoms was equal in both groups and bacteriuria was eliminated equally successfully in both regimens. There was no significant difference between the two groups in the incidence of side effects from the drugs. The financial saving which could accrue from adopting this therapeutic regimen would be significant.
This small study was carried out to assess the effectiveness of lactulose syrup (Duphalac) in the management of constipation in forty-six patients with terminal illnesses. The daily dose of lactulose was titrated to meet the individual patients requirements and was found to be in the region of 20 to 30 mls twice daily, despite the almost universal administration of opiates as analgesics. The study lasted 21 days in each patient capable of completing the assessment. Constipation was relieved within a an average of 3 to 4 days, and of the 512 days observed, there were 203 days in which a bowel movement occurred. Of these motions 71% were recorded as easy to move, rather than hard (21%) of loose (8%). Faecal incontinence and nausea attributable to lactulose treatment were extremely rare. Therefore, lactulose appeared to be a useful treatment for constipation in the terminally ill patient.
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