PURPOSE: Moxifloxacin 8-methoxy-quinolone has an excellent in virto activity against common gram positive, gram negative and intracellular respiratory tract pathogens. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is characterized by increase in cough and worsening of dyspnoea due to, in some cases, bacterial infection. There is always a need to develop first line antimicrobial agents that cover major respiratory pathogens, with low potential to select for resistance, favorable safety and tolerability profiles, and convenient dosing regimen. The purpose of this study was to evaluate the outcome of treating AECOPD patients empirically with 400 mg moxifloxacin single oral dose for 5 and 10 days.
METHODS: This was an open, prospective, clinical trial. Patients were males and females aged 18-65 years, identified with AECOPD, who have not had antibiotics within 14 days before enrollment. Test of cure (TOC) was defined as disappearance of signs and symptoms of AECOPD with no requirement for further treatment with antibiotics. Adverse events, including abnormal laboratory values, were monitored, recorded and analyzed.
RESULTS: One hundred and twenty four patients were enrolled according to inclusion and exclusion criteria. After 5 days of treatment, the clinical outcome was 89% cure in the per-protocol (PP) patients and 84% in intent-to-treat (ITT) analyses. The cure rates increased after 10 days to 99% and 94% in the PP and ITT analyses respectively. The main adverse event was gastric upset. Nonetheless, all adverse events were of mild to moderate intensity and were easily alleviated with symptomatic intervention.
CONCLUSION: The empiric treatment with Moxifloxacin for AECOPD patients appears to be safe and efficacious.
CLINICAL IMPLICATIONS: The results of this work support those found elsewhere in the literature and the FDA results on Moxifloxacin 8–methoxy-quinolone in the AECOPD indication.
DISCLOSURE: Abdalla Hussein, None.