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

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.

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.

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.