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.
ABSTRACT
The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies—both sponsored and investigator initiated—were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study’s progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator’s (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies