Moxifloxacin monotherapy compared to amoxicillin-clavulanate plus roxithromycin for nonsevere community-acquired pneumonia in adults with risk factors

Abstract

The objective of this study was to assess the efficacy and safety of moxifloxacin versus amoxicillin-clavulanate plus roxithromycin (comparator) in adult community-acquired pneumonia (CAP) patients with risk factors. In this comparative, randomized, multicenter, open-label study, patients hospitalized for CAP received a 10-day oral treatment with either moxifloxacin (400 mg o.d.) or amoxicillin-clavulanate (1,000/125 mg t.i.d.) plus roxithromycin (150 mg b.i.d.). Clinical and bacteriological outcomes were assessed during test of cure and follow-up visits (5-7 days and 21-28 days after the end of treatment, respectively). Of 349 randomized patients, 346 were included in the intent-to-treat analysis and 289 in the per-protocol analysis. Their baseline characteristics were comparable. The most frequent risk factors for mortality were age >65 years (50.0%), alcoholism (23.1%), and comorbidities (50.6%); chronic obstructive pulmonary disease (COPD) (25.4%) and diabetes mellitus (13.6%) were the most common associated comorbidities. A causative pathogen was documented in 66 of 346 (19.1%) of the patients (including 21 with positive blood cultures). Respective per-protocol clinical success rates at test-of-cure (primary efficacy endpoint) for moxifloxacin and comparator were 131 of 151 (86.8%) and 120 of 138 (87.0%), with a 95% confidence interval (CI) of -8.0-7.6 for the difference. Bacteriological success rates (eradication) were 23 of 30 (76.7%) and 23 of 31 (74.2%); rates for patients with positive blood cultures were 10 of 14 and 4 of 6. Persistent clinical success rates at follow-up were 118 of 120 (98.3%) and 102 of 106 (96.2%), with a 95%CI of -2.2-6.4 for the difference. The intent-to-treat analysis confirmed these results. Adverse events associated with moxifloxacin and the comparator drug were reported for 42 of 171 (24.6%) and 50 of 175 (28.6%) of the patients, respectively, and comprised predominantly digestive disorders, which occurred in 9.4% and 21.1%. On the basis of these results, once-daily oral moxifloxacin alone is as effective as amoxicillin-clavulanate plus roxithromycin for the treatment of CAP in patients with risk factors.

Respiratory fluoroquinolones for the treatment of community-acquired pneumonia: a meta-analysis of randomized controlled trials

“…[14][15][16][17][18]20,21,26,27,[29][30][31][32] Isolates recovered from all patients enrolled in the studies were tested for resistance against the study antibiotics and for penicillin resistance. Only one S. aureus isolate resistant to levofloxacin was found in these 13 studies.…”

“…Data about mortality in the intention-to-treat population were provided in 18 trials [14][15][16][17][18][19]21,22,24,26,27,[29][30][31][32][33][34]36 and ranged from 0% to 7% (mean 2.7%) in the fluoroquinolone groups and from 0.5% to 8% (mean 3.4%) in the comparator groups. Mortality rates were not different between the 2 groups of patients (Figure 2, OR 0.85, 95% CI 0.65-1.12).…”

“…14,15,[19][20][21][26][27][28][31][32][33][34][35][36] Overall, treatment with fluoroquinolones was successful for 84.2% of patients. Treatment with comparator antibiotics was successful for 82.2% of patients.…”

“…18,22,25,27,31,35 However, they were not more effective in the analysis that included trials funded by pharmaceutical companies (OR 1.13, 95% CI 0.93-1.38). [14][15][16][17][19][20][21]23,24,26,[28][29][30][32][33][34]36 Twelve trials included patients with severe pneumonia; of these, 7 reported data from this population. 16,19,26,27,29,33,34 In this subgroup, fluoroquinolones were more effective than the comparator antibiotics (OR 1.84, 95% CI 1.02-3.29).…”

Comparison of ampicillin-sulbactam/macrolide dual therapy versus fluoroquinolone monotherapy in hospitalized patients with community-acquired pneumonia

“…Literatürde F ile AS ± M kullanımının karşılaştırıldığı çalışmalarda gruplar arasında farklı sonuçlar mevcuttur (10-13). F ile AS ± M alan hastaların karşılaştırıldığı birçok çalışmada mikrobiyolojik eradikasyon, semptom kontrolü ve klinik başarı tedavi grupları arasında benzer etkinlikte saptanmıştır (14)(15)(16)(17)(18)(19)(20)(21). Klinik başarı kombinasyon grubunda %79 ile %92, solunum florokinolonları grubunda %79 ile %89 arasında değiştiği görülmüştür.…”