Specific Versus Empirical Anthelminthic Treatment in Eosinophilia

NCT06265870 | Recruiting DMC

• 1 other identifier: Parasite in Eosinophilia
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilia

Keywords

eosinophilia; anthelminthic drugs; empirical treatment; stool examination

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in AEC

  From receive anthelminthic treatment to the end of treatment at 4 weeks

Study Arms (2)

Specific anthelminthic

ACTIVE COMPARATOR

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

Empirical anthelminthic

PLACEBO COMPARATOR

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

Interventions

Albendazole DRUG

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

Empirical anthelminthic

Ivermectin or albendazole DRUG

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

Specific anthelminthic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Physical examination revealed a body temperature equal to or greater than 37.8 degrees Celsius, lymphadenopathy or hepatosplenomegaly.
• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla University - Hat Yai Campus: Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Related Publications (18)

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  PMID: 33865302 RESULT

• 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 Biomed (Res Rev News). 2023 Jun 16;16(5):273-282. doi: 10.2478/abm-2022-0030. eCollection 2022 Oct.

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  PMID: 34533850 RESULT

• 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. 2017 Feb;176(4):553-572. doi: 10.1111/bjh.14488. Epub 2017 Jan 23. No abstract available.

  PMID: 28112388 RESULT

• 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.

  PMID: 28546866 RESULT

• 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.

  PMID: 26744590 RESULT

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

  PMID: 18564693 RESULT

• 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. eCollection 2023.

  PMID: 36712467 RESULT

• 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. Korean.

  PMID: 19571614 RESULT

• 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.

  PMID: 34080735 RESULT

• 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.

  PMID: 16681635 RESULT

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

  PMID: 31690387 RESULT

• 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.

  PMID: 31757229 RESULT

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  PMID: 22073495 RESULT

• 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.

  PMID: 17399779 RESULT

• 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.eimc.2015.11.019. Epub 2016 Jan 27. English, Spanish.

  PMID: 26827134 RESULT

• 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.

  PMID: 30197068 RESULT

• 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.

  PMID: 26393130 RESULT

MeSH Terms

Conditions

Eosinophilia

Interventions

Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Thareerat Ananchaisarp

  Prince of Songkla University - Hat Yai Campus: Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thareerat Ananchaisarp

CONTACT

66858898592; thareerat.a@psu.ac.th

Wisarut Srisintorn

CONTACT

wisarut.s@psu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 20, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

TH (1)