Specific Versus Empirical Anthelminthic Treatment in Eosinophilia

Eosinophilia Clinical Trial

— Eosinophilia  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265870
• Other study ID #: Parasite in Eosinophilia
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Prince of Songkla University
• Contact: Thareerat Ananchaisarp
• Phone: +66858898592
• Email: thareerat.a[@]psu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

References & Publications (18)

Ananchaisarp T, Chamroonkiadtikun P, Julamanee J, Perdvong K, Chimpalee T, Rattanavirakul N, Leelarujijaroen N, Hathaipitak T, Tantinam T. Prevalence and management of eosinophilia based on periodic health examinations in primary care clinics. Asian Biome — View Citation

Butt NM, Lambert J, Ali S, Beer PA, Cross NC, Duncombe A, Ewing J, Harrison CN, Knapper S, McLornan D, Mead AJ, Radia D, Bain BJ; British Committee for Standards in Haematology. Guideline for the investigation and management of eosinophilia. Br J Haematol — View Citation

Carranza-Rodriguez C, Escamilla-Gonzalez M, Fuentes-Corripio I, Perteguer-Prieto MJ, Garate-Ormaechea T, Perez-Arellano JL. Helminthosis and eosinophilia in Spain (1990-2015). Enferm Infecc Microbiol Clin (Engl Ed). 2018 Feb;36(2):120-136. doi: 10.1016/j. — View Citation

Chanswangphuwana C, Uaprasert N, Moonla C, Rojnuckarin P. Causes and outcomes of hypereosinophilia in a tropical country. Asian Pac J Allergy Immunol. 2021 Apr 18. doi: 10.12932/AP-221220-1021. Online ahead of print. — View Citation

Chen B, Fu Y, Wang Z, Rong Q, Zhang Q, Xie J, Kong X, Jiang M. Eosinophilia attention, diagnosis, treatment, and awareness in physicians: a cross-sectional survey. Ther Adv Chronic Dis. 2023 Jan 24;14:20406223221146938. doi: 10.1177/20406223221146938. eCo — View Citation

Guo C, Bochner BS. Workup for eosinophilia. Allergy Asthma Proc. 2019 Nov 1;40(6):429-432. doi: 10.2500/aap.2019.40.4264. — View Citation

Insiripong S, Siriyakorn N. Treatment of eosinophilia with albendazole. Southeast Asian J Trop Med Public Health. 2008 May;39(3):517-20. — View Citation

Khanna V, Tilak K, Mukhopadhyay C, Khanna R. Significance of Diagnosing Parasitic Infestation in Evaluation of Unexplained Eosinophilia. J Clin Diagn Res. 2015 Jul;9(7):DC22-4. doi: 10.7860/JCDR/2015/12222.6259. Epub 2015 Jul 1. — View Citation

Khoury P, Bochner BS. Consultation for Elevated Blood Eosinophils: Clinical Presentations, High Value Diagnostic Tests, and Treatment Options. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1446-1453. doi: 10.1016/j.jaip.2018.04.030. — View Citation

Kim DW, Shin MG, Yun HK, Kim SH, Shin JH, Suh SP, Ryang DW. [Incidence and causes of hypereosinophilia (corrected) in the patients of a university hospital]. Korean J Lab Med. 2009 Jun;29(3):185-93. doi: 10.3343/kjlm.2009.29.3.185. Erratum In: Korean J La — View Citation

Kuang FL. Approach to Patients with Eosinophilia. Med Clin North Am. 2020 Jan;104(1):1-14. doi: 10.1016/j.mcna.2019.08.005. — View Citation

Magnaval JF, Laurent G, Gaudre N, Fillaux J, Berry A. A diagnostic protocol designed for determining allergic causes in patients with blood eosinophilia. Mil Med Res. 2017 May 23;4:15. doi: 10.1186/s40779-017-0124-7. eCollection 2017. — View Citation

Rosenwasser LJ. Approach to patients with eosinophilia. Mo Med. 2011 Sep-Oct;108(5):358-60. — View Citation

Shomali W, Gotlib J. World Health Organization-defined eosinophilic disorders: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Jan 1;97(1):129-148. doi: 10.1002/ajh.26352. Epub 2021 Oct 8. — View Citation

Simon D, Simon HU. Eosinophilic disorders. J Allergy Clin Immunol. 2007 Jun;119(6):1291-300; quiz 1301-2. doi: 10.1016/j.jaci.2007.02.010. Epub 2007 Apr 2. Erratum In: J Allergy Clin Immunol. 2007 Sep;120(3):515. — View Citation

Tefferi A, Patnaik MM, Pardanani A. Eosinophilia: secondary, clonal and idiopathic. Br J Haematol. 2006 Jun;133(5):468-92. doi: 10.1111/j.1365-2141.2006.06038.x. — View Citation

Vaisben E, Brand R, Kadakh A, Nassar F. The role of empirical albendazole treatment in idiopathic hypereosinophilia - a case series. Can J Infect Dis Med Microbiol. 2015 Nov-Dec;26(6):323-4. doi: 10.1155/2015/531675. — View Citation

Wardlaw AJ, Wharin S, Aung H, Shaffu S, Siddiqui S. The causes of a peripheral blood eosinophilia in a secondary care setting. Clin Exp Allergy. 2021 Jul;51(7):902-914. doi: 10.1111/cea.13889. Epub 2021 Jun 3. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eosinophilia recovery	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