Sulbactam-Durlobactam for ABC Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find the right dose of a new treatment, Sulbactam-Durlobactam (an intravenous antibiotic), for children with a serious bacterial infection called Acinetobacter baumannii-calcoaceticus complex (ABC). Researchers are testing the safety and behavior of this medication in the body to determine how it can best help children needing intravenous antibiotics for their infection. Hospitalized children confirmed or suspected to have ABC infections might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking all current medications, but you cannot use medications that inhibit organic anion transporter 1 (like probenecid) or have taken sulbactam, durlobactam, or amphotericin B recently. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that Sulbactam-Durlobactam is likely to be safe for pediatric patients?
Research has shown that sulbactam-durlobactam has undergone testing in several studies to assess its safety. Many patients, both adults and children, have used this treatment, and researchers have collected their safety information.
The treatment is generally well-tolerated. The most common side effects were mild, such as headaches or stomach upset, which are often expected with antibiotics. Serious side effects were rare. Some studies examined allergic reactions, but these were uncommon.
Sulbactam-durlobactam has also been compared to another antibiotic, colistin. Results indicated that sulbactam-durlobactam was not only effective but also safe.
As this trial is in an early phase, the treatment is being tested for safety in humans, with careful monitoring to ensure any side effects remain manageable. Previous research provides some confidence in its safety, but it continues to be closely studied.12345Why do researchers think this study treatment might be promising for ABC infections?
Sulbactam-Durlobactam is unique because it combines two powerful antibiotics to tackle ABC infections, which are often resistant to standard treatments like carbapenems and cephalosporins. Researchers are excited about this treatment due to its dual action: sulbactam works to inhibit bacterial cell wall synthesis, while durlobactam protects sulbactam from being broken down by resistant bacteria. This combination not only enhances the effectiveness of sulbactam but also expands its spectrum of activity against tough-to-treat bacterial strains. This dual mechanism offers a promising new approach in the fight against resistant infections, potentially improving outcomes for pediatric patients.
What evidence suggests that Sulbactam-Durlobactam might be an effective treatment for ABC infection?
Research has shown that Sulbactam-Durlobactam (SUL-DUR), the investigational treatment in this trial, holds promise for treating infections caused by the Acinetobacter baumannii-calcoaceticus complex (ABC). One study found that SUL-DUR successfully cleared infections in 66.7% of patients with a single type of bacteria. Another study demonstrated that SUL-DUR was effective in over 95% of cases, regardless of the infection site, such as the lungs or bloodstream. Additionally, it reduced deaths from serious ABC infections, even when other treatments failed. Overall, these findings suggest SUL-DUR could be a strong option for fighting ABC infections.23467
Are You a Good Fit for This Trial?
This trial is for pediatric patients with infections caused by the Acinetobacter baumannii-calcoaceticus complex. Specific eligibility criteria are not provided, but typically include a confirmed diagnosis of the infection and possibly other health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Sulbactam-Durlobactam every 6 hours based on age and weight cohort
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sulbactam-Durlobactam
Trial Overview
The study tests two different doses of Sulbactam-Durlobactam (20mg/kg and 25mg/kg) to find out how they affect children with ABC infections. It aims to gather data on how the body processes the drug (pharmacokinetics) and its safety.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Aged birth to \<2 months, term and preterm (gestational age \>28 weeks and post-natal age \>7 days) Term infants will receive 25mg/kg SUL and 25mg/kg DUR Preterm infants will receive 20mg/kg SUL and 20mg/kg DUR
Aged 2 months to \<3 months, term and preterm (gestational age \>28 weeks) Term infants will receive 25mg/kg SUL and 25mg/kg DUR Preterm infants will receive 20mg/kg SUL and 20mg/kg DUR
Pediatric patients 3 months to \<1 year of age
Pediatric patients 1 year to \<6 years of age
Pediatric patients 6 years to \<12 years of age Sulbactam 25mg/kg -Durlobactam 25mg/kg, not to exceed 1g sulbactam - 1g durlobactam (Every 6 hours)
Pediatric patients 12 years to \<18 years of age Sulbactam 25mg/kg -Durlobactam 25mg/kg, not to exceed 1g sulbactam - 1g durlobactam (Every 6 hours)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innoviva Specialty Therapeutics
Lead Sponsor
Entasis Therapeutics
Industry Sponsor
Citations
New Perspectives on Antimicrobial Agents - PubMed Central
Though comparative clinical data are relatively limited to date, sulbactam-durlobactam has shown more promising results than cefiderocol for ...
Clinical Outcomes for Patients With Monomicrobial vs ...
Likewise, the percentage of favorable microbiological outcomes at TOC for patients in the sulbactam-durlobactam arm was 66.7% (24/36) for monomicrobial ...
results from ACNBio study - ASM Journals
Sulbactam-durlobactam retained >95% activity across patient location (ICU vs non-ICU) and infection source (respiratory vs bloodstream). On the ...
Sulbactam–durlobactam for infections caused by ...
Results from the ATTACK trial show the safety and efficacy of sulbactam–durlobactam for the treatment of hospital-acquired and ventilator- ...
Efficacy and safety of sulbactam–durlobactam versus ...
Sulbactam–durlobactam was well tolerated and could be an effective intervention to reduce mortality from serious infections caused by carbapenem-resistant ABC, ...
NCT06746883 | A Study to Assess the Safety and Risk of ...
The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including ...
Sulbactam-durlobactam for the treatment of serious ...
Safety data on SUD was collected from 8 clinical studies including 6 Phase 1 studies, 1 Phase 2 trial and one randomized, controlled Phase 3 ...
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