Specific Versus Empirical Anthelminthic Treatment in Eosinophilia (Eosinophilia)

September 22, 2024 updated by: Thareerat Ananchaisarp, Prince of Songkla University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Recruiting
        • Prince of Songkla University - Hat Yai Campus: Prince of Songkla University
        • Contact:
          • Thareerat Ananchaisarp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Albendazole
Participants receive empiric anthelminthic treatment which is albendazole 400 mg twice a day for seven consecutive days
Active Comparator: 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.
Drug: Ivermectin or albendazole
Participants will receive specific anthelminthic treatment tailored to the results of the stool tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eosinophilia recovery
Time Frame: 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.
From receive anthelminthic treatment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AEC
Time Frame: From receive anthelminthic treatment to the end of treatment at 4 weeks
Comparing 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.
From receive anthelminthic treatment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Thareerat Ananchaisarp, Prince of Songkla University - Hat Yai Campus: Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parasite in Eosinophilia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets used and/or analyzed during the current study are available at primary researcher and may share with author research on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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