CTRI/2010/091/000154未知3 期
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.4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- ?Clinical cure (defined as absence of symptoms and signs of infection at day 10 of treatment) and ?Bacteriological cure (defined as a negative culture to S. typhi at day 10 of treatment).
研究概览
简要总结
This study is 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 in 200 patients will be conducted in four centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
?Clinical cure (defined as absence of symptoms and signs of infection at day 10 of treatment) and ?Bacteriological cure (defined as a negative culture to S. typhi at day 10 of treatment).
时间窗: 10 day
次要结局
- ?Number of treatment responders and treatment failures [treatment failures defined as fever and symptoms persisting for >7 d after the start of therapy, the development of severe or complicated disease and presence of salmonella in the blood culture done after 7 days]?Number of paracetamol tablets taken to control the fever during the 10-day study period?Time when there was no fever for continuous 24 hours without any antipyretic medication received.?Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) administered at the completion visit.(7 days)
研究者
研究点 (4)
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