Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections.
Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections.
复制标题
DOI：
10.1186/1475-2875-1-13
复制
发表时间：
2002-11-12
期刊：
影响因子：
3
通讯作者：
Brouqui, Philippe
中科院分区：
文献类型：
--
作者：
Ranque, Stephane;Badiaga, Sekene;Brouqui, Philippe
背景技术背景：序贯分析允许在整个试验招募期间进行重复统计分析，同时保持预先规定的把握度和I类错误。因此，一旦所积累的信息被认为足以得出结论，就可以停止试验。序贯检验易于使用，其统计特性特别适用于目标非常直接的试验，如非比较性II期试验。我们报告的第二阶段研究的基础上的三角检验（TT），旨在评估阿奇霉素在预防间日疟原虫resistance.METHODS的有效性：为了测试是否间日疟原虫复发率为或= 45%的患者用阿奇霉素治疗，一个连续的分析的基础上TT被使用。感染间日疟原虫的患者用阿奇霉素治疗，每日1.2 g，连续7天。复发性感染的发病进行了monitored.Results：5例急性间日疟原虫感染的患者被纳入本研究。所有患者均初步治愈。3例患者报告轻度胃肠道不良反应。当第三名患者复发时，样本路径越过TT的上边界，并且试验被stopped.CONCLUSIONS：使用三角检验，只有少数患者，我们得出结论，阿奇霉素在预防间日疟原虫复发方面不够有效，需要在III期进一步评估。建议在II期抗感染药物试验中更广泛地使用序贯分析可能具有经济和伦理效益。
BACKGROUND: Sequential analysis enables repeated statistical analyses to be performed throughout a trial recruitment period, while maintaining a pre-specified power and type I error. Thus the trial can be stopped as soon as the information accumulated is considered sufficient to reach a conclusion. Sequential tests are easy to use and their statistical properties are especially suitable to trials with very straightforward objectives such as non-comparative phase II trials. We report on a phase II study based on the triangular test (TT) aiming at assessing the effectiveness of azithromycin in preventing Plasmodium vivax relapses.METHODS: To test whether the P. vivax relapse rate was either or= 45% in patients treated with azithromycin, a sequential analysis based on the TT was as used. Patients infected with P. vivax were treated with azithromycin, 1.2 g daily, for 7 days. The onset of a relapse infection was monitored.RESULTS: Five patients presenting with an acute P. vivax infection were included in the study. All the patients were initially cured. Three patients reported mild gastrointestinal adverse effects. When the third patient relapsed, the sample path crossed the upper boundary of the TT, and the trial was stopped.CONCLUSIONS: Using the triangular test, with only a small number of patients, we concluded that azithromycin was not effective enough in preventing P. vivax relapses to warrant further evaluation in phase III. It is suggested that a wider use of sequential analysis in phase II anti-infective drugs trials may have financial and ethical benefits.