Clinical trial

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

Name
Parasite in Eosinophilia
Description
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.
Trial arms
Trial start
2024-04-10
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Not yet recruiting
Treatment
Albendazole
Participants receive empiric anthelminthic treatment which is albendazole 400 mg twice a day for seven consecutive days
Arms:
Empirical anthelminthic
Ivermectin or albendazole
Participants will receive specific anthelminthic treatment tailored to the results of the stool tests
Arms:
Specific anthelminthic
Size
700
Primary endpoint
Eosinophilia recovery
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 700, 'type': 'ESTIMATED'}}
Updated at
2024-04-03

1 organization

2 products

1 indication

Indication
Eosinophilia
Product
Ivermectin