Sulbactam-Durlobactam for ABC Infection

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Innoviva Specialty Therapeutics

No Placebo Group

Trial Summary

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.

+2 more

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

+16 more

Participant Groups

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.

6Treatment groups

Experimental Treatment

Group I: Cohort 5 Subgroup 2Experimental Treatment2 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 1Experimental Treatment2 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 4Experimental Treatment1 Intervention

Pediatric patients 3 months to \<1 year of age

Group IV: Cohort 3Experimental Treatment1 Intervention

Pediatric patients 1 year to \<6 years of age

Group V: Cohort 2Experimental Treatment1 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 1Experimental Treatment1 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)