Conditions
Suspected or Documented Gram-negative Bacterial Infection
Trial Purpose
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.
NATIONAL TRIAL REFERENCE NUMBER
NCT03969901
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
0 - 17
Sex
All
About The Study
Trial Phase
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Actual study start date October 8, 2019
- Estimated primary completion date May 7, 2024
- Estimated study completion date May 7, 2024
Trial Locations
Sorry, there are no locations found.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risksRiskChance (likelihood) for an event, reaction or health problem to happen and possible benefits are for participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant.
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about