ORAL AZITHROMYCIN VS DOXYCYCLINE IN TREATMENT OF CHILDREN WITH SCRUB TYPHUS WITHOUT COMPLICATIONS - AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To compare the efficacy of two drugs in terms of percentage of children who attained remission of fever after 72 hours of administration of first dose of the study drug
研究概览
简要总结
Objectives -To compare the efficacy of Azithromycin versus Doxycycline in treatment ofchildren with uncomplicated scrub typhus in terms of percentage of children whoattained remission of fever after 72 hours of administration of first dose ofthe study drug, mean time taken to attain fever defervescence, normalisation oflaboratory parameters, resolution of hepatosplenomegaly and lymphadenopathy.
Design – Interventional,Open labelled Randomized Controlled Trial
Study methods - Patientsadmitted with undifferentiated fever in the In-Patient Department (IPD),Department of Paediatrics, All India Institute of Medical Sciences, Bhubaneswaras per the inclusion criteria were randomised and was treated with Azithromycinat 10mg/kg/day in one group and Doxycycline at 4.4mg/kg/day in the other groupand was assessed based on the primary and secondary objectives.
Results - Therewas no statistically significant difference between the percentage of childrenwho attained remission of fever after 72 hours of administration of Azithromycin(98%) and Doxycycline (96%) (p value-0.48) and the average time taken for feverdefervescence (Azithromycin – 24.6 hours Doxycycline – 25.7 hours, p value-0.32). The odds of attaining fever remission in Doxycycline group as comparedto Azithromycin group was 0.62 (95 % confidence interval (CI) - (0.16 – 2.3)) which was also statisticallynot significant. There was less incidence of adverse drug events inAzithromycin group (1.96%) as compared to Doxycycline group (9.09%) which wasstatistically significant (p value-0.01).
**Conclusion -**Azithromycin is equally efficacious in terms of fever defervescence, resolutionof clinical signs and laboratory parameters as Doxycycline and is safer andmore tolerated in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients falling under the ‘suspected, probable and confirmed case definitions ‘ as per IAP guidelines on Ricketssial diseases in children based on clinical and epidemiological criterias.
排除标准
- •Patients with a known allergy to either of these drugs Patients participating in other clinical trials Children with any other known systemic illness Children with any major congenital malformations  Children who have received antimicrobial drugs with antirickettsial activity in the preceeding 2 weeks (doxycycline/azithromycin/chloramphenicol/rifampicin).
结局指标
主要结局
To compare the efficacy of two drugs in terms of percentage of children who attained remission of fever after 72 hours of administration of first dose of the study drug
时间窗: After 72 hours of administration of first dose of the study drug
次要结局
- Clinical resolution of hepatosplenomegaly and lymphadenopathy.
- Time required for normalization of(a)Liver enzymes - AST and ALT between 40 U/L)
- Adverse drug events of the medications being used(On a daily basis)
- Rate of treatment failures(After 72 hours)
- Time taken for defervescence of fever for either drug after the first dose of drug(Monitored every 4 hourly)