To establish a nationwide registry of people who have experienced liver injury within the past 10 years after using any of 7 specific drugs: isoniazid (INH), phenytoin (Dilantin), combination clavulanic acid/amoxicillin (Augmentin), and valproic acid (Depakote), Nitrofurantoin, Trimethoprim-sulfamethoxazole, Minocycline, and Quinolone antibiotics.
Your participation is voluntary and will cost you nothing. You will receive a nominal fee to cover any expenses associated with the study and to compensate you for your effort. You may drop out of the study at any time.
Your identity will be kept confidential. Your name will not be on the blood sample you give, and any results of the blood sample will not go into your medical records. Your records will be kept confidential. Only representatives of the National Institutes of Health, an institutional review board, and the data coordinating center at the Duke Clinical Research Institute may review them.
You may not receive any direct benefit from this study, but you are contributing in an important way to medical research that may benefit others in the future. If we can discover why people have unwanted reactions to drugs, we may be able to design safer drugs in the future.
How the Study Will Proceed
- You will receive a consent form and a release-of-medical-information form.
- A study contact person will call you to review the forms and answer any questions you may have.
- The contact person will schedule you to complete a questionnaire, which can be done by phone, and to provide a blood sample. You can do both during one visit. For the questionnaire, you will need to know when you started taking the medication, when you started having liver problems, other drugs and herbal preparations you were taking around that time, names of all doctors who were helping you during that time, and any related information about members of your family.
- You will be asked to sign the consent and release-of-medical-information forms and give them to a study contact person.
- After providing your blood sample, your participation will have ended for the first year. Thereafter, a study contact person will try to contact you annually to keep your contact information up to date.
Remember: You may withdraw from the study at any time and request that your blood sample be destroyed.