Fixed Dose Combination of Oral Cefixime and Moxifloxacin Improves Symptoms in Lower Respiratory Tract Infections

5 Jan, 21

Introduction

Management of respiratory tract infections (RTIs) poses a major challenge to the physicians mainly due to the emerging antibiotic resistance. The Central Drug Standard Control Organization (CDSCO) has currently approved cefixime 400 mg and moxifloxacin 400 mg fixed dose combination (FDC) in the management of lower RTIs (LRTIs) in India. Cefixime and moxifloxacin FDC has enhanced activity against clinically important gram-positive, gram-negative and atypical organisms and is associated with prevention of emergence of drug resistance and increased patient compliance. Despite these advantages, there is no data related to its real-world usage.

Aim

This study evaluates the real-world efficacy and safety of this FDC in LRTI.

Methods

Study Design

Retrospective, multi-center, real-world study

Treatment Strategy

The study was conducted in out-patient departments of 5 hospitals between August 2018 and January 2019
Adults diagnosed with LRTI who received FDC of cefixime (400 mg) and moxifloxacin (400 mg) for at least 72 hours were enrolled
The LRTI symptoms were evaluated using a 5-point assessment scale at baseline and on days 3, 5, 7 and 10 (5=complete absence of symptoms and 1=worst severity)

Endpoints

Improvement in the below LRTI symptoms
- cough
- sputum volume
- sputum purulence
- fever
- dyspnea
- pleuritic chest pain
- sleep disturbance
- fatigue
White blood cell (WBC) counts at baseline and end-of-treatment
Adverse events (AEs)

Results

The study included 190 patients having mean age 42.33+16.15 years
Majority were males (61.58%), with community acquired pneumonia (CAP) being the most common LRTI (84.21%)
Commonest clinical symptom was cough, which was reported by 97.37%
There was a significant improvement in all mean symptom scores at day 3 and day 5 of follow up (p<0.05) in all the patients
All the patients had a decreased sputum volume and absence of sputum purulence on days 3 and 5
There was a significant improvement in fever, pleuritic chest pain, dyspnea, cough, sleep and fatigue in all the patients at days 3 and 5
There was a significant decrease in the WBC count at the end of antibiotic treatment as compared to baseline
Out of the 30 patients having WBC above normal range at baseline, 29 (96.67%) demonstrated a decrease in count at end of treatment
There were no incidences of any AEs

Conclusion

In a real-world clinical setting, the fixed dose combination of oral cefixime (400 mg) and moxifloxacin (400 mg) was effective in improving all symptoms in patients with lower respiratory tract infections without causing any adverse event.

Int J Adv Med. 2019 Dec;6(6):1808-813.