Specific Versus Empirical Anthelminthic Treatment in Eosinophilia

Official title

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

Overview

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

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

Primary outcome measures

• Eosinophilia recovery [Time frame: From receive anthelminthic treatment to the end of treatment at 4 weeks]

Secondary outcome measures (1)

• Change in AEC [Time frame: From receive anthelminthic treatment to the end of treatment at 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 1 center

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

Publications

• 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. PMID 33865302
• 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. PMID 37551315
• 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. PMID 34533850
• 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
• 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
• 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
• Insiripong S, Siriyakorn N. Treatment of eosinophilia with albendazole. Southeast Asian J Trop Med Public Health. 2008 May;39(3):517-20. PMID 18564693
• 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

Identifiers

NCT: NCT06265870 · Parasite in Eosinophilia

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗