Clinical Trials / Research Studies
Study for Adults 18 to 50 Years Old
Why are we doing this research?
The purpose of the trial is to learn about the effects and safety of the trial drug EDI048 to treat diarrhea caused by a Cryptosporidium infection, also called Crypto. Crypto is an infection caused by a parasite that causes diarrhea and other gut-related symptoms.
Who can participate?
Healthy adults between 18 and 50 years old.
Conditions
- Healthy Adults
What will happen in the study?
You will be in the trial for up to 12 weeks. During that time, you will visit the trial site about 4 times, including an overnight stay of approximately 8-14 days. You will also have up to 6 phone calls with trial staff.
At the trial visits, you will have these assessments:
- Review health history
- Stool sample collection
- Urine sample collection
- Blood sample collection
- Capillary blood collection (a new method of blood collection)
- Physical exam
- Electrocardiogram (ECG)
During the stay in the extended stay research unit, study staff will be available at all times to care for you.
Adults interested in participating in this study will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
There is no direct benefit to you for participating in this study. However, when we complete the study, we hope to know more about how to treat could people infected with Crypto in the future.
What are the bad things that can happen from this research?
Possible risks and discomforts will be discussed with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
Participants may receive up to $7290 to complete the study over approximately 12 weeks.
Contact
Gamble Program for Clinical Studies513-636-7699
gambleprogram@cchmc.org
Infectious Diseases
Cincinnati Children’s Hospital Medical Center
2850 Winslow Ave.
Cincinnati, OH 45206-3039
www.clinicaltrials.gov NCT# 07249463
Study Doctor
Robert Frenck
Infectious Diseases
Cincinnati Children’s Hospital Medical Center
Find More
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To see if you qualify, click here for the study survey:
https://redcap.link/cryptospore
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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