Specific Versus Empirical Anthelminthic Treatment in Eosinophilia

NCT ID: NCT06265870

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Eosinophilia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Ivermectin or albendazole

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Albendazole

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Albendazole

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

Intervention Type DRUG

Ivermectin or albendazole

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thareerat Ananchaisarp

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thareerat Ananchaisarp

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thareerat Ananchaisarp

Role: CONTACT

66858898592

Wisarut Srisintorn

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thareerat Ananchaisarp

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Chanswangphuwana C, Uaprasert N, Moonla C, Rojnuckarin P. Causes and outcomes of hypereosinophilia in a tropical country. Asian Pac J Allergy Immunol. 2024 Dec;42(4):403-408. doi: 10.12932/AP-221220-1021.

Reference Type RESULT
PMID: 33865302 (View on PubMed)

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.

Reference Type RESULT
PMID: 37551315 (View on PubMed)

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.

Reference Type RESULT
PMID: 34533850 (View on PubMed)

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.

Reference Type RESULT
PMID: 28112388 (View on PubMed)

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.

Reference Type RESULT
PMID: 28546866 (View on PubMed)

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.

Reference Type RESULT
PMID: 26744590 (View on PubMed)

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

Reference Type RESULT
PMID: 18564693 (View on PubMed)

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.

Reference Type RESULT
PMID: 36712467 (View on PubMed)

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.

Reference Type RESULT
PMID: 19571614 (View on PubMed)

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.

Reference Type RESULT
PMID: 34080735 (View on PubMed)

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.

Reference Type RESULT
PMID: 16681635 (View on PubMed)

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

Reference Type RESULT
PMID: 31690387 (View on PubMed)

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.

Reference Type RESULT
PMID: 31757229 (View on PubMed)

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

Reference Type RESULT
PMID: 22073495 (View on PubMed)

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.

Reference Type RESULT
PMID: 17399779 (View on PubMed)

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.

Reference Type RESULT
PMID: 26827134 (View on PubMed)

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.

Reference Type RESULT
PMID: 30197068 (View on PubMed)

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.

Reference Type RESULT
PMID: 26393130 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Parasite in Eosinophilia

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.