Sulbactam-Durlobactam for ABC Infection

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

Trial Summary

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 Sulbactam-Durlobactam safe for humans?

Sulbactam-Durlobactam has been tested in clinical trials and is generally considered safe for humans, including those with different levels of kidney function. In a study, it was found that even with kidney issues, the treatment did not show any negative effects on safety or tolerability. ^{1 2 3 4 5}

How is the drug Sulbactam-Durlobactam different from other treatments for ABC infection?

Sulbactam-Durlobactam is unique because it combines sulbactam, which has intrinsic antibacterial activity against Acinetobacter, with durlobactam, a novel inhibitor that effectively blocks a wide range of enzymes that make bacteria resistant to antibiotics. This combination restores the effectiveness of sulbactam against resistant strains of Acinetobacter, making it a promising option for treating multidrug-resistant infections. ^{1 2 3 4 6}

What is the purpose of this trial?

The goal of this clinical trial is to investigate the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients and is being conducted to collect pharmacokinetic (PK) and safety data to enable the identification of appropriate pediatric dosing regimens for patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Sulbactam/Durlobactam: First Approval. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Pharmacokinetics/Pharmacodynamic Relationship of Durlobactam in Combination With Sulbactam in In Vitro and In Vivo Infection Model Systems Versus Acinetobacter baumannii-calcoaceticus Complex. [2023]

4. England pubmed.ncbi.nlm.nih.gov

In vitro activity of sulbactam/durlobactam against clinical isolates of Acinetobacter baumannii collected in China. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Intravenous Durlobactam and Sulbactam in Subjects with Renal Impairment and Healthy Matched Control Subjects. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Tolerability of Intravenous Sulbactam-Durlobactam with Imipenem-Cilastatin in Hospitalized Adults with Complicated Urinary Tract Infections, Including Acute Pyelonephritis. [2020]