Comparison of Outcome Between Specific Anthelminthic Treatment According to Test Results and Empirical Anthelminthic Treatment in Eosinophilic Patient
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Eosinophilia recovery
研究概览
简要总结
There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study.
详细描述
Eosinophilia is defined as an absolute eosinophil count exceeding 500 cells per microliter, calculated by multiplying the white blood cell count by the percentage of eosinophils.
Cause of eosinophilia vary from mild to life-threatening disease. Prevalence of each cause of eosinophilia vary on study population, the most common etiology in developing country is parasite infection.
Stool microscopy can be conducted using various methods. The Kato-Katz technique, recommended by the WHO, exhibits a sensitivity of only 52.4 percent (95%CI = 47.6 - 57.1 percent). More sensitive methods for parasite detection in stool, such as stool culture or PCR, are not readily available and can be costly. In the intervention group of this study, the investigators employed three different parasite detection methods (stool microscopy, stool culture, and PCR) to enhance sensitivity in detecting parasites.
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
- None
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
- •Participants who come for check-ups at general practitioner, primary care unit, and Srivejchavat Premium Center have an absolute eosinophil count greater than 500 cells/microliter with a white blood cell count less than 10,000 cells/microliter.
- •Age at least 18 years old
- •Consent to participate in research
排除标准
- •Having any characteristics that need urgent care 1.1 Having history of unintended significant weight loss is defined as the loss of body weight exceeding 10% within a span of six months without deliberate attention.
- •1.2 Physical examination revealed a body temperature equal to or greater than 37.8 degrees Celsius, lymphadenopathy or hepatosplenomegaly.
- •1.3 CBC revealed blast cell
- •Receiving anthelminthic drug within 6 months
- •Underlying cancer (active stage), HIV, HBV, HCV, collagen vascular disease, active TB
- •Allergy to albendazole, ivermectin, or metronidazole
- •Pregnancy or lactation
- •Serum transaminase higher than 2 times of upper normal limit
- •Taking medications that may induce eosinophilia within the past three months, such as herbal supplements, NSAIDs, Salicylic acid, Carbamazepine, Colchicine, Nitrofurantoin, Dapsone, or Minocycline, was reported.
研究组 & 干预措施
Specific anthelminthic
Participants were asked to provide stool samples for three consecutive days for testing through microscopy, culture, and PCR to detect parasites.
- This study will combine wet smear and Kato's thick smear methods, with duplicate samples collected from each stool specimen to maximize parasite detection. To ensure reliability, two experienced microscopists will independently examine all four slides, and an independent report generated. In cases of discrepant results, a third microscopist will arbitrate, and the final diagnosis determined by majority vote.
- Stool culture will look for Strongyloides stercoralis and hookworm larvae.
- Stool PCR: Targeted gene of 7 helminths will be amplified and detected by multiplex real-time PCR. The reaction will be dividing into three assays.
Following the analysis of the stool samples, participants will receive specific anthelminthic treatment tailored to the results of the stool tests.
干预措施: Ivermectin or albendazole (Drug)
Empirical anthelminthic
Participants will receive an empirical anthelminthic regimen consisting of albendazole 400 mg twice a day for seven consecutive days. Following this treatment, a follow-up complete blood count (CBC) will be requested to assess responsiveness.
干预措施: Albendazole (Drug)
结局指标
主要结局
Eosinophilia recovery
时间窗: From receive anthelminthic treatment to the end of treatment at 4 weeks
Recovery from eosinophilia was defined as an absolute eosinophil count of less than 500 cells per microliter, as measured from the complete blood count (CBC) four weeks after receiving anthelminthic treatment.
次要结局
- Change in AEC(From receive anthelminthic treatment to the end of treatment at 4 weeks)
研究者
Thareerat Ananchaisarp
Principal Investigator
Prince of Songkla University