CE8565-0001-GRQ
Clinical trial of a new compound that is being developed for the treatment of bacterial infections
€1.517,-
Super well organized
Super well organized
Study groups
The research physician about this research
In bacterial infections, foreign bacteria enter the body and start growing there. Such ‘pathogens’ are less likely to cause harm if the immune system is strong enough. If that is not the case, a person becomes ill, for example due to an inflammation. Sometimes antibiotics are then prescribed. These are medicines that kill bacteria or inhibit their growth. The study compound can possibly be used to treat infections that do not respond to antibiotics. It works in a new way by activating your body’s defense system. This study consists of three parts: Part A, Part B, and Part C. Only Part A and Part B will take place at our research center. You can only participate in one part.
In this study, we will investigate how safe the study compound is and how well it is tolerated when it is used by healthy people. Additionally, we will investigate the levels of the study compound in blood and urine. We will also investigate whether the body produces antibodies (an immune response) against the study compound. Furthermore, we will explore the biological activity of the study compound and the presence of anti-rhamnose antibodies. Anti rhamnose antibodies occur naturally present in your body and have a positive effect on your body’s immune system. In Part B, we will see how the study compound affects the bacteria in the gut.
We will compare the effects of the study compound with the effects of a placebo. A placebo is a compound without any active ingredient. Whether you will receive the study compound or placebo will be determined by chance.
You will receive a solution of the study compound or placebo administered directly into a blood vessel through an infusion. In Part A, you will receive the study compound once. In Part B, you will receive the study compound twice daily for 7 days.
All (potential) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. In rare cases (<0.1%), serious side effects can occur during the first administration to humans. The compound has already been extensively tested in the laboratory and on animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any question you may have. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
Who can participate?
Note:
What is the compensation for this research?
You will receive a gross compensation of € 1517 for full participation in Part A. For full participation in Part B of the trial, you will receive a gross compensation of € 2899.
Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.
How long does the research take?
Part A of the trial consists of 1 period during which you will stay in the research facility in Groningen for 4 days (3 nights), followed by 2 short visits. The last visit is the follow-up visit and will take place 9 to 13 days after your departure from the research facility.
Part B of the trial consists of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights), followed by 3 short visits. The last visit is the follow-up visit and will take place 17 to 23 days after your departure from the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website. The location in Groningen is Van Swietenlaan 6.
If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).
During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.
You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.