Risks
Main risk
The main risk in this study is that if you get a beta-lactam alone, you may not improve as much as if you get both antibiotics.
- You and your care team will know which IV antibiotics you are getting. Your care team will be monitoring your progress while you are on the antibiotics. They can make changes to your care if necessary.
- The CFF will be following along as the study is being conducted to monitor safety.
Antibiotics
Both types can cause an allergic reaction, including a severe allergic reaction with swelling in the throat or difficulty breathing. Both types also have their own specific risks.
Antibiotics
Associated risks
Aminoglycosides
Example: tobramycin
The risks include kidney injury, hearing loss, ringing in the ears, balance problems, and, rarely, muscle weakness. These problems may develop gradually after repeated use but can be permanent and are sometimes severe.
Beta-lactams
Example: ceftazidime
The risks are temporary and include abdominal pain, diarrhea, nausea and vomiting, decreased white blood cells, decreased platelets, and skin rashes.
Study activities
Many of the study activities are the same as those done at standard clinic visits and have the same minimal risks.
Study activities
Associated risks
Sputum collection
Coughing up sputum may cause temporary shortness of breath.
Pulmonary function test
Pulmonary function testing can cause temporary wheezing, shortness of breath, and lightheadedness.
Health questions
Sometimes people may feel uncomfortable answering certain questions. If this happens, please talk to the research team about why that question is being asked. If you are still uncomfortable, you do not have to answer the question.
Medidata app
To complete the questions, you will need to download an app that will take up space on your phone. Medidata is a separate company from our research team and makes the app. Information about how Medidata uses your information is found in their terms of use. There could be privacy risks associated with using the app. Read Medidata’s privacy notice if you’d like to learn more.
Sharing personal information
There is a small chance that someone could access your study data, including your personal information or online responses, without permission.
This study may also have unknown risks.
Withdrawal from study
- You can stop being in the study at any time for any reason.
- You could also need to be removed from the study for unexpected reasons.