Sulbactam-Durlobactam for ABC Infection

Recruiting at 3 trial locations

Overseen By ISTX Clinical Trials

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Innoviva Specialty Therapeutics

Must be taking: IV antibiotics

Must not be taking: OAT1 inhibitors, Amphotericin B

Disqualifiers: Preterm birth, Refractory septic shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

48 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 3 4 6 7}

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

Patient and/or parent(s) or legal guardian(s) have provided the written informed consent and/or assent

I am under 18, hospitalized, and can give informed consent.

I need IV antibiotics for a confirmed or suspected ABC infection.

Exclusion Criteria

I am currently on peritoneal dialysis or cardiopulmonary bypass.

I am scheduled for a blood transfusion within 24 hours of starting the study drug.

Patient is pregnant, breastfeeding, or intends to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sulbactam-Durlobactam every 6 hours based on age and weight cohort

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Cohort 5 Subgroup 2 Experimental Treatment 2 Interventions

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

Group II: Cohort 5 Subgroup 1 Experimental Treatment 2 Interventions

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

Group III: Cohort 4 Experimental Treatment 1 Intervention

Pediatric patients 3 months to \<1 year of age

Group IV: Cohort 3 Experimental Treatment 1 Intervention

Pediatric patients 1 year to \<6 years of age

Group V: Cohort 2 Experimental Treatment 1 Intervention

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)

Group VI: Cohort 1 Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Innoviva Specialty Therapeutics

Lead Sponsor

Trials

3

Recruited

180+

Entasis Therapeutics

Industry Sponsor

Trials

10

Recruited

670+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12486857/

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 ...

2. academic.oup.com academic.oup.com/ofid/article/11/4/ofae140/7632375

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 ...

3. journals.asm.org journals.asm.org/doi/10.1128/aac.00379-25

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 ...

4. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(23)00423-1/fulltext

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- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309923001846

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, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06746883

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 ...

7. conferences-on-demand.faseb.org conferences-on-demand.faseb.org/do/10.1096/BIAC2025.S10.P04/full/

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 ...