Research & Innovation

Clinical Trials

Clinical Trials

PSU PA Babesia Study

Evaluation of the Immune Response and Antigenic Signature of Patients with Babesia Infection in Pennsylvania with the Aim of Developing a Rapid Diagnostic Test

Physician & Study Coordinator

Physician

Thong P Le, M.D. practices Infectious Diseases in Bethlehem

Thong Le, MD

Study Coordinator

Thomas Parsons, RN
484-526-6076

Thomas.Parsons@sluhn.org

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Synopsis

Synopsis: The purpose of this voluntary research study is to find out if PSU can create a rapid diagnostic test for the diagnosis of Babesiosis. This type of test currently does not exist.

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Inclusion Criteria

Laboratory Criteria (at least one of the following)

  • Identification of intraerythrocytic Babesia organisms by light microscopy in a Giemsa, Wright, or Wright-Giemsa–stained blood smear; OR
  • Detection of Babesia microti DNA in a whole blood specimen by polymerase chain reaction (PCR); OR
  • Detection of Babesia spp. genomic sequences in a whole blood specimen by nucleic acid amplification; OR
  • Isolation of Babesia organisms from a whole blood specimen by animal inoculation.

 

Clinical Criteria (at least one of the following)

  • Objective: one or more of the following: fever, anemia, or thrombocytopenia.
  • Subjective: one or more of the following: chills, sweats, headache, myalgia, or arthralgia.

 

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Exclusion Criteria

For patients with acute Babesiosis, excluded patients will include:

  • Patients less than 18 years of age
  • Patients that do not meet the CDC criteria (outlined above) for Babesiosis or patients that have negative blood smears or negative PCR at the time of initial blood draw
  • Refusal or lack of capacity or lack of legally authorized representative to sign consent form.

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