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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06265870
Acronym
Eosinophilia
Enrollment
700
Registered
2024-02-20
Start date
2024-05-01
Completion date
2025-12-31
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilia

Keywords

eosinophilia, anthelminthic drugs, empirical treatment, stool examination

Brief 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.

Interventions

DRUGAlbendazole

Participants receive empiric anthelminthic treatment which is albendazole 400 mg twice a day for seven consecutive days

DRUGIvermectin or albendazole

Participants will receive specific anthelminthic treatment tailored to the results of the stool tests

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Eosinophilia recoveryFrom receive anthelminthic treatment to the end of treatment at 4 weeksRecovery 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.

Secondary

MeasureTime frameDescription
Change in AECFrom receive anthelminthic treatment to the end of treatment at 4 weeksComparing the change in AEC from baseline between the "specific treatment group" and the "empirical treatment group" using either a paired t-test or the Wilcoxon signed-rank test.

Countries

Thailand

Contacts

Primary ContactThareerat Ananchaisarp
thareerat.a@psu.ac.th66858898592
Backup ContactWisarut Srisintorn
wisarut.s@psu.ac.th

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026