A Phase 2 study of the novel fluoroquinolone JNJ-Q2 in community-acquired bacterial pneumonia

Sir, JNJ-Q2 is a fifth-generation fluoroquinolone with in vitro coverage of community-acquired bacterial pneumonia (CABP) pathogens, atypical respiratory pathogens, multidrug-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus. This double-blind, randomized, non-inferiority, ethics-approved study was designed to enrol 120 hospitalized and consented CABP subjects at 60 sites. It was done in accordance with international guidelines and was based on the 2009 FDA CABP guidance,1 with the following two exceptions: (i) one dose of a short-acting antibiotic within 4 h before randomization; and (ii) mandatory requirement for sputum production. Patients aged 18–85 years with a PORT score of ≥II and at least three CABP signs/symptoms were eligible for enrolment (cough, dyspnoea/tachypnoea, chest pain, fever/hypothermia or pulmonary consolidation). Sputum with a positive Gram's stain and a chest X-ray (CXR) showing infiltrates in at least lobar distribution were required for entry. Subjects were stratified by PORT score (II/III versus IV/V) and age (1200 patients in 24 months at 303 centres, only 2% of their population came from the USA.7 Respiratory pathogen recovery rate was unusually high. Sputum PCR testing remains an experimental tool8 and requires that clinicians distinguish between colonization and infection. In our study, each patient with S. pneumoniae PCR-positive sputum had ≥5.3 × 104 copies per mL, exceeding the rate recommended by Yang et al.9 Compared with historical pathogen identification rates (generally