A Multicentric, Open label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety of oral tablets of Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg in Comparison with Cefpodoxime 200 mg alone in patients with respiratory tract infection [RTI] and typhoid fever

Akums Drugs & Pharmaceuticals Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•All subjects with duly filled and signed in ICFs [Informed Consent Forms]
•Male and female outpatients ³ 18 years of age.
•Clinical diagnosis of respiratory tract infection [RTI] by virtue of following signs & symptoms:
•oProduction of sputum
•oLeukocytosis
•oRadiographic abnormality
•Sputum/ urine culture defining presence of gram-negative and gram-positive bacteria with susceptibility to cefpodoxime and ofloxacin [Culture specimens will be processed in an automatic device (BacT Alert System, Organon Teknika Corp., UK].
•Formerly healthy patients, with functional gastrointestinal tract, and without intestinal complications as perforation or extraintestinal complications like lymphadenitis, arthritis, multifocal osteomyelitis, brain abscesses, pneumonia or sepsis
•If female, using birth control
•Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.

•Patients unwilling to sign on ICF
•Patients with hypersensitivity to cephalosporins or fluoroquinolones
•Patient who severe complications of RTI/ Typhoid fever
•Patients having received antibiotic medication within 14 days prior to dosing
•Patients who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27
•An uncontrolled, unstable clinically significant medical condition
•Clinically significant abnormal laboratory, vital sign or ECG findings at screening;
•A positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days;
•Patient with history of bronchial asthma, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD) and cystic fibrosis.
•Patient with history of gastritis, hyperacidity, peptic ulcer disease
•Judged by the principal investigator (PI) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment

发起方

Akums Drugs & Pharmaceuticals Limited