Urine Collection: This will be used for storage in the biobank. We will collect about 10 mLs (2 teaspoons) of urine. Chest X-Ray: At Month 2 and the End of Treatment Visits, results of your chest x-rays will be collected, if done as part of your regular medical care. You will not have a chest x-ray for this study at these visits. We will keep a copy of your chest x-ray as part of your study records and it may also be used in future studies. Treatment Failure/Relapse/Withdrawal Evaluation If you are not getting better, or after you finish your TB treatment you get sick again, or if you decide you want to come off the study for any reason, you will return for an extra visit as soon as possible. You will have most of the same evaluations you had at the Entry Visit. If you want stop being in the study we find out that the medicines are not working or to or your TB came back this will be your final visit. WHAT ARE THE POSSIBLE RISKS? The samples being taken for biobank storage may be taken during routine medical care and procedures. There is minimal risk to you if you decide to participate in this study. The following describes some of the possible risks: Drawing may cause some discomfort, bleeding, and/or bruising where the needle enters the skin. In rare cases, there may be fainting or infection. The IRB/IEC only allows a certain amount of blood to be drawn in 1 day for your safety. We will only take an amount that is allowed by the IRB/IEC. are no risks with coughing up sputum or breathing steam-like mist to help with deep coughing. A gastric aspiration (getting a stomach sample) is a simple procedure that involves putting a small flexible tube down your child’s nose. This may cause some discomfort and/or cause your child to gag. Chest x-rays are done as part of routine medical care. The amount of radiation emitted during a chest x-ray is small and poses no significant risks to you. If you are pregnant, you will not be required to have a chest x-ray.
Urine Collection: This will be used for storage in the biobank. We will collect about 10 mLs (2 teaspoons) of urine. Chest X-Ray: At Month 2 and the End of Treatment Visits, results of your chest x-rays will be collected, if done as part of your regular medical care. You will not have a chest x-ray for this study at these visits. We will keep a copy of your chest x-ray as part of your study records and it may also be used in future studies. Treatment Failure/Relapse/Withdrawal Evaluation If you are not getting better, or after you finish your TB treatment you get sick again, or if you decide you want to come off the study for any reason, you will return for an extra visit as soon as possible. You will have most of the same evaluations you had at the Entry Visit. If you want to stop being in the study or we find out that the medicines are not working or your TB came back this will be your final visit. WHAT ARE THE POSSIBLE RISKS? The samples being taken for biobank storage may be taken during routine medical care and procedures. There is minimal risk to you if you decide to participate in this study. The following describes some of the possible risks: Drawing may cause some discomfort, bleeding, and/or bruising where the needle enters the skin. In rare cases, there may be fainting or infection. The IRB/IEC only allows a certain amount of blood to be drawn in 1 day for your safety. We will only take an amount that is allowed by the IRB/IEC. are no risks with coughing up sputum or breathing steam-like mist to help with deep coughing. A gastric aspiration (getting a stomach sample) is a simple procedure that involves putting a small flexible tube down your child’s nose. This may cause some discomfort and/or cause your child to gag. Chest x-rays are done as part of routine medical care. The amount of radiation emitted during a chest x-ray is small and poses no significant risks to you. If you are pregnant, you will not be required to have a chest x-ray.
RePORT-International-Common-Protocol-V1.1-12Jan16-Template.docx