We all have a duty to protect children, and new treatments are needed.
We all have a duty to protect children, and antibiotic resistance is becoming a big problem that requires new treatments. Gram-negative bacteria can cause serious infections that are difficult to treat with antibiotics. Our CHERISH trial aims to develop a potential medicine for children under 9 months of age. All the children that participate in the trial will receive care from a team of dedicated healthcare professionals and your child’s safety is the top priority of this trial.
Who may participate
CHERISH may be an option if your child has been hospitalized with a suspected or confirmed bacterial infection, are younger than 9 months old and require Intravenous (IV) antibiotics.
When you and your child participate in a clinical trial it is a personal choice. You are making a decision to help your community and all children globally affected by bacterial infections.
The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people. Many factors, such as genetics, race, ethnicity, gender, and age, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. Everyone needs to be represented.
Condition
GNB (Gram-negative bacteria) Infections
Age
Under 9 months
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If your child enrolls in the trial, they will receive the study medicine which is a combination of an existing antibiotic medicine and another existing medicine used to combat antibiotic resistance.
Your child’s health will be carefully monitored by the CHERISH trial team for 5 to 7 weeks.
Overall we anticipate about 4 to 6 visits to the hospital and 1 phone call. These will be a mixture of bedside visits and follow-up appointments.
There is no cost to participate in this study. You will also be compensated for completing study-related activities.
Length of study treatment
5 to 7 weeks
Number of study visits
About 4 to 6 visits and 1 phone call
Frequently asked questions
Your child will be in the trial about 5 weeks if they are participating in Part A, or about 7 weeks if they are participating in Part B. There will be one follow-up telephone call with the study doctor to check on your child’s health about a month after the last dose of study medicine.
The clinical trial will be conducted in 2 parts. In Part A, your child will receive a single dose of study medicine, which will take about 3 hours. In Part B, your child will receive the study medicine for up to 2 weeks as treatment and the study medicine will be given as an intravenous infusion over 3 hours every 6 to 8 hours during the treatment period.
Your child’s health may get better, get worse, or stay the same. Their health will be closely monitored during the trial. Participation may help children in the future by increasing our understanding of the study medicine and serious gram-negative bacterial infections. Every medicine that we depend on for our children today was only made possible because of families like yours, who decided to join a trial.
If your child’s health gets worse, your study doctor will help you decide what to do, which may mean stopping their participation in the trial. Potential risks from taking part in the trial may include: side effects from taking the study medicine, for example diarrhea, nausea, vomiting, and abdominal pain; risks or discomforts from study procedures such as blood tests and the IV infusion; and risk of allergic reaction to the study medicine.
The study medicine is a combination of an antibiotic and another drug which combats antibiotic resistance. All participants will receive the study medicine.
We understand that making a decision to participate in a clinical trial may be difficult during this time. Please feel free to ask the study doctor any questions you may have. With the support of the study team, you can decide what’s best for your child.
