BridgeMD
A study to assess how Vaborem® is taking up in the body and tolerated in paediatric patients with serious infections.
EU CTIS ID: 2024-514656-32-00
What this study is testing
To assess the PK of meropenem and vaborbactam following multiple IV infusion doses of VaboremⓇ to paediatric participants from birth to <18 years with suspected or confirmed Gram negative infections.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent before initiation of any study-related procedures. Parent or legal representative has given informed consent, as appropriate, and the participant has given assent where appropriate.
- Male or female, from birth to < 18 years of age. Participants aged < 3 months are eligible if gestational age at birth is > 32 weeks.
- Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator’s judgement.
- Confirmed or suspected Gram negative infection, according to the diagnostic criteria reported in APPENDIX 1 for participants aged 3 months < 18 years and in APPENDIX 2 for participants < 3 months of age.
You likely can't join if
- History of any moderate or significant hypersensitivity or allergic reaction to betalactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).
- Renal function at screening as estimated by creatinine clearance <50 mL/min/1.73m2 (<30 mL/min/1.73 m2 in participants aged < 3 months) using the Schwartz eGFR formula.
- Presence of any condition reported as exclusion criteria in Appendix 1 and Appendix 2.
- Anticipated need for antibacterial therapy longer than 14 days.
- Endocarditis, osteomyelitis, abscess, meningitis, C. difficile infection diagnosed within 7 days prior to start of treatment.
- On treatment or expected to receive immunosuppressive agents, valproic acid or probenecid.
See the full eligibility criteria
Who can join
- Written informed consent before initiation of any study-related procedures. Parent or legal representative has given informed consent, as appropriate, and the participant has given assent where appropriate.
- Male or female, from birth to < 18 years of age. Participants aged < 3 months are eligible if gestational age at birth is > 32 weeks.
- Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator’s judgement.
- Confirmed or suspected Gram negative infection, according to the diagnostic criteria reported in APPENDIX 1 for participants aged 3 months < 18 years and in APPENDIX 2 for participants < 3 months of age.
What rules you out
- History of any moderate or significant hypersensitivity or allergic reaction to betalactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).
- Renal function at screening as estimated by creatinine clearance <50 mL/min/1.73m2 (<30 mL/min/1.73 m2 in participants aged < 3 months) using the Schwartz eGFR formula.
- Presence of any condition reported as exclusion criteria in Appendix 1 and Appendix 2.
- Anticipated need for antibacterial therapy longer than 14 days.
- Endocarditis, osteomyelitis, abscess, meningitis, C. difficile infection diagnosed within 7 days prior to start of treatment.
- On treatment or expected to receive immunosuppressive agents, valproic acid or probenecid.
- Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy
- Presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term use of systemic corticosteroids (equivalent to >2mg/kg/day for more than 1 week or > 1mg/kg/day in participants under 20kg for more than 14 days of prednisone or systemic equivalent.).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × ULN, or total bilirubin >1.5 × ULN (except for known Gilbert’s disease).
- Receipt of any investigational medication or investigational device during the last 30 days prior to start of treatment and until the End of Study visit.
- Requirement at time of enrollment, for any reason, for additional systemic antibiotic therapy (other than study drug) or antifungal therapy.
- Unable or unwilling, in the judgement of the Investigator, to comply with the protocol or complete the clinical study.
- Known history of human immunodeficiency virus (HIV) infection with a CD4 count <200/mm3 or, in children aged <5 years, CD4% <15%.
- Presence of neutropenia (<500 polymorphonuclear leukocytes- PMNs/mm3) unless justified by the investigated infection as per Investigator’s judgement.
- Presence of thrombocytopenia (<60,000 platelets/mm3).
- Presence of severe anemia (Hb < 8 g/dL)
- Is or has an immediate family member of the Investigator or Site staff directly involved in the proposed study.
- Receipt of an antibacterial drug for the investigated Gram negative infection for a continuous duration of more than 24 hours during the previous 72 hours. Exceptions apply to: a. participants who have received >48 hours of prior systemic antibiotic therapy for the investigated infection with unequivocal clinical or microbiological evidence of treatment failure (i.e., worsening of signs and symptoms); b. participants who have received antimicrobial prophylaxis or who have received antibiotics for another indication and have developed signs and symptoms of investigated infection.
- Participants with a concurrent infection requiring additional systemic antimicrobial treatment.
- Any surgical or medical condition which, in the opinion of the Investigator, would put the participant at increased risk (e.g. unlikely to survive to the study period, or with rapidly progressive illness including septic shock) or is likely to interfere with study procedures or PK of the study drug.
- Females who are of childbearing potential (i.e. fertile, following menarche unless permanently sterile due to hysterectomy, bilateral salpingectomy and bilateral oophorectomy) and unwilling to practice abstinence or use at least two methods of contraception (see APPENDIX 3 - BIRTH CONTROL METHODS APPLICABLE IN VABOR-KIDS-01 STUDY) during the entire study period and up to 28 days after VaboremⓇ discontinuation.
- Pregnant or breastfeeding female adolescent participants or a positive serum β human chorionic gonadotropin (hCG) pregnancy test at Screening.
- Male adolescents who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e. condom with spermicide).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.