.svg?iar=0&updated=20230109065058&hash=B8F025B8AA9A24E727DBB30EAED272C8){kind=logo}
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.
