Efficacy of Azithromycin Plus Doxycycline Compared to Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever in Hospital General de Mexicali of ISESALUD and Hospital General No. 30 Instituto Mexicano Del Seguro Social
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Mortality of azithromycin plus doxycycline vs doxycycline plus placebo
研究概览
简要总结
The aim of this study is to impove the pharmacological treatment of Rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease.
详细描述
Rocky mountain spotted fever is a potentially fatal infectious disease wich is transmitted trough vectors. This particular infection is caused by Rickettsia rickettsii wich is a gramnegative intracellular bacilli. The pathophysiological mechanism and clinical manifestation is mainly due to the vascular affectation, since this pathogen has a tropism for endothelial cells. As it has been mentioned, this is an obligate intracellular pathogen, so the main choice with the antibiotic therapy is tetracyclines because of its action mechanism in the inhibition of the subunit 30S. The objective of the study is to prove new strategies of treatment to improve the pharmacological aproach by implementing Azithromycin, wich is a macrolide that inhibits de 50S subunit of the bacteria. Azithromycin has shown effectivity against other rickettsial diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients will be randomized through the program ¨Randomizer for Clinical Trial¨ to be assigned in group of treatment A or B. One of the treatments will be azithromycin 500 mg orally every 24 hours for three dose plus doxycycline 100 mg orally every 12 hours for 7 days and the other schedule it will be doxycycline 100 mg orally every 12 hours for 7 days plus placebo 1 capsule every 24 hours, 3 doses.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Over 18 years old
- •hospitalized in the internal medicine service, emergency department or intensive care unit of Hospital General de Mexicali (ISESALUD) or Hospital General Zona No. 30 (IMSS) with suspicion of RMSF that present fever and 2 or more of the next symptoms: headache, myalgia, rash, nausea, pharyngeal hyperemia, vomiting, abdominal pain, neurological disorders.
- •In addition to at least one of the next epidemiologycal fators: presence of vectors in areas of residence or endemic areas visited two weeks prior to the onset of symptoms, history of visiting or residing in areas with RMSF transmission in the last two weeks, existence of confirmed cases in the locality of origin, history of vector bite or contact with dogs in the two weeks.
排除标准
- •Other clinical suspicion rather than RMSF
- •History of allergy to doxycycline, azithromycin, bean starch or bovine gelatin.
- •Not signing the informed consent
- •Pregnancy.
研究组 & 干预措施
A
Azithromycine group
干预措施: Azithromycin + Doxycycline (Drug)
B
Placebo group
干预措施: Placebo + Doxycycline (Drug)
结局指标
主要结局
Mortality of azithromycin plus doxycycline vs doxycycline plus placebo
时间窗: 3 years
次要结局
- Number of hospitalization days in each arm(3 years)
- Number of participants with renal replacement therapy.(3 years)
- Number of participants that required amines in both groups.(3 years)
- Number of fever days in both arms.(3 years)
研究者
Hiram Jaramillo Ramirez
Clinical professor
Hospital General de Mexicali