Effectiveness and safety evaluation of oral cefixime and moxifloxacin fixed dose combination in lower respiratory tract infections

ABSTRACT

Background: Scientific literature advocates the need for combination therapies in combatting lower respiratory tract infection (LRTI). Cefixime (400 mg) and moxifloxacin (400 mg) fixed dose combination (FDC) is currently approved in India for the management of LRTI, but data related to its real world usage is lacking. The present study was designed to understand the real world use (effectiveness and safety) of this FDC in LRTI.Methods: This retrospective study was conducted at out-patient departments of 5 hospitals between August 2018 and January 2019. After ethics committee approval, data of adults LRTI patients who received FDC of cefixime (400 mg) and moxifloxacin (400 mg) for at least 72 hours was collected. Improvement in LRTI symptoms (cough, sputum volume and purulence, fever, dyspnea, pleuritic chest pain, sleep disturbance, fatigue) were scored at baseline and follow-up using a 5-point severity scale. White blood cell (WBC) counts at baseline and end-of-treatment were compared.Results: Data of 190 patients having mean age 42.33+16.15 years was evaluated. Majority were males (61.58%), with commonest LRTI infection being community acquired pneumonia (CAP) (84.21%). Commonest clinical symptom reported (97.37%) was cough. All patients showed improvement in symptoms and significant improvement in all mean symptom scores were noted (p<0.05). Of the 30 patients having WBC above normal range, 29 showed a decrease in count at end of treatment. No adverse events were reported.Conclusions: Oral FDC of cefixime (400 mg) and moxifloxacin (400 mg) was efficacious in improving all symptoms reported by LRTI patients without causing any adverse event.