NCT06265870

Specific Versus Empirical Anthelminthic Treatment in Eosinophilia

Comparison of Outcome Between Specific Anthelminthic Treatment According to Test Results and Empirical Anthelminthic Treatment in Eosinophilic Patient

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Eosinophilia

Interventions

Type	Name	Description
DRUG	Albendazole	Participants receive empiric anthelminthic treatment which is albendazole 400 mg twice a day for seven consecutive days
DRUG	Ivermectin or albendazole	Participants will receive specific anthelminthic treatment tailored to the results of the stool tests

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-02-20
• Last updated: 2024-09-24

Locations

1 site across 1 country: Thailand