Adding clarithromycin to standard of care appears to improve clinical response and reduce inflammation in patients with community-acquired pneumonia, as reported in the phase III ACCESS trial.
ACCESS included 278 adults with community-acquired pneumonia who had systemic inflammatory response syndrome, Sequential Organ Failure Assessment (SOFA) score of 2 or more, and procalcitonin of at least 0.25 ng/mL. These patients were randomly assigned to receive standard of care medication (including intravenous administration of a third-generation cephalosporin or of β-lactam plus β-lactamase inhibitor combination) plus either oral placebo (n=139) or oral clarithromycin 500 mg (n=139) twice daily for 7 days.
The primary composite outcome required that patients fulfilled both of the following conditions at day 4 of treatment: (1) decrease in respiratory symptom severity score of ≥50 percent and (2) decrease in SOFA score of ≥30 percent or favourable procalcitonin kinetics (defined as ≥80-percent decrease from baseline or procalcitonin <0.25 ng/mL) or both.
In total, 68 percent of patients in the clarithromycin group and 38 percent in the placebo group achieved the primary outcome (odds ratio [OR], 3.40, 95 percent confidence interval [CI], 2.06–5.63; p<0.0001).
In terms of safety, serious treatment-emergent adverse events (TEAEs) were documented in 43 percent patients in the clarithromycin group and 53 percent in the placebo group (OR, 1.46, 95 percent CI, 0.89–2.35; p=0.14). None of the serious TEAEs were deemed to be related to the study treatment.