Specific Versus Empirical Anthelminthic Treatment in Eosinophilia

ConditionEosinophilia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrince of Songkla University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Receiving anthelminthic drug within 6 months

Underlying cancer (active stage), HIV, HBV, HCV, collagen vascular disease, active TB

Allergy to albendazole, ivermectin, or metronidazole

Trial design

Design model

Parallel

Treatments tested in this trial

  • Albendazole

    Drug

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

  • Ivermectin or albendazole

    Drug

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

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Specific anthelminthicActive comparator 1 intervention
Group B: Empirical anthelminthicPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Change in AEC

Comparing the change in AEC from baseline between the \"specific treatment group\" and the \"empirical treatment group\" using either a paired t-test or the Wilcoxon signed-rank test.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.