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 Cefixime 200 mg and Ofloxacin 200 mg in Comparison with Ofloxacin 200 mg Alone in Patients with Typhoid Fever

M/s. Akums Drugs & Pharmaceuticals Ltd.0 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.
•Currently suffering from an typhoid fever characterized by > 100° F for more than three days with malaise, body ache and absence of tachycardia or relative decrease in pulse rate with increased body temperature
•Blood culture defining presence of salmonella typhi with susceptibility to cefixime and ofloxacin
•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 typhoid fever
•Patients having received antibiotic medication within 14 days prior to dosing
•Patients having received typhoid vaccine within 4 weeks 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

M/s. Akums Drugs & Pharmaceuticals Ltd.