CTRI/2012/10/003060Other3 期
A STUDY OF THE EFFICACY AND TOLERABILITY OF MOXIFLOXACIN AND GATIFLOXACIN CONTAINING REGIMENS IN THE TREATMENT OF PATIENTS WITH SPUTUM-POSITIVE PULMONARY TUBERCULOSIS - Not applicable
ICMR0 个研究点目标入组 1,200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients aged 18 years and above residing in or around Chennai or Madurai will be eligible for enrollment to the study. They should not have anti-TB treatment in the past or should have had less than one month of treatment (but less than one week in the preceding one month before enrollment in the study).
- •They should have sputum culture-positive pulmonary tuberculosis (at least two cultures should be positive). Patients will be enrolled to the study when two sputum smears are positive and will be retained for analysis only if two cultures are positive.
- •They should consent to attend the treatment centre for supervised treatment for 6 months and for home visits by the staff of the center.
- •They should give written informed consent.
排除标准
- •body weight less than 30 kg
- •hepatic or renal disease as evidenced by clinical or biochemical abnormalities
- •diabetes mellitus
- •a history of seizures
- •psychiatric illness
- •an abnormal electrocardiogram or those on anti-arrhythmic medication
- •Those in a moribund state
- •Those sero-positive for HIV antibodies
- •Pregnant or lactating women
研究者
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