Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)Phase 1NCT06801223
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
A Phase 1 study testing Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) and Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours) in people with Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), run by Innoviva Specialty Therapeutics at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
- What is being tested?
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) and Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Dec 2026to 20 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient from birth (defined as post-natal age of 7 days) to <18 years of age at the time of written informed consent (and assent, if applicable) and is hospitalized.
- Patient and/or parent(s) or legal guardian(s) have provided the written informed consent and/or assent.
- Patient has confirmed or suspected diagnosis of ABC infection and requires IV antibiotics for treatment.
- Patient has expected survival of 30 days after enrollment in the study.
- If patient is an individual of childbearing potential or reproductive potential, then the patient must remain abstinent OR must utilize one of the highly effective methods of contraception (ie, condom, combined oral contraceptive, implant, or injectable) from at least 30 days prior to screening until at least 30 days after administration of the last dose of study drug.
Who cannot join
- Patient is a preterm infant, born at <28 weeks gestational age.
- Patient has history of significant hypersensitivity or allergic reaction to any β-lactam, any contraindication to the excipients used in the formulation, or any contraindication to the use of β-lactam antibiotics. Note: For β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment.
- Patient is in refractory septic shock at the time of enrollment, defined as persistent hypotension despite adequate fluid resuscitation or vasopressive therapy.
- Patient is pregnant, breastfeeding, or intends to become pregnant.
- Patient is receiving peritoneal dialysis or cardiopulmonary bypass.
- Patient has received blood transfusion within 24 hours of study drug administration.
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- Patient is a newborn with clinically significant anemia who, in the opinion of the investigator, will not be able to tolerate the necessary blood draws to complete the study activities.
- Patient (or patient's mother, if the patient is being breastfed) is using or will need to use any medications known to inhibit organic anion transporter 1 (OAT1) (eg, probenecid).
- Patient has clinically significant renal, hepatic, or hemodynamic instability.
- For Cohorts 1 through 3 only: patient has weight outside of the 5th to 95th percentile based on age.
- Patient has an age-appropriate estimated creatinine clearance that indicates renal impairment.
- Patient has the following laboratory results at Screening:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3×upper limit of normal (ULN) and,
- Total bilirubin >2×ULN for age with conjugated/direct bilirubin >20% of the total. Note: Patients with AST or ALT up to 5×ULN are eligible if these elevations are acute and are documented as being directly related to the infectious process being treated.
- Patient has clinically significant abnormal laboratory test results not related to the underlying infection that might expose the patient to risk by participating in the trial, confound the results of the trial, or interfere with the patient's participation for the full duration of the trial.
- Patient (or patient's mother, if the patient is being breastfed) has participated in a clinical study involving investigational medication or an investigational device within the last 30 days or 5 half-lives, whichever is longer, prior to first dose of the study drug.
- Patient has any condition that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
- Patient is unable or unwilling, in the opinion of the investigator, to comply with the protocol.
- Patient (or patient's mother, if the patient is being breastfed) has previously received durlobactam.
- Patient (or patient's mother, if the patient is being breastfed) has received sulbactam and/or sulbactam-containing regimens (eg, Unasyn) within 72 hours of first dose of the study drug.
- Patient (or patient's mother, if the patient is being breastfed) has received amphotericin B within 7 days of first dose of the study drug.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-5302
- Recruiting
ECU Brody School of Medicine
Greenville, North Carolina, 27834
- Recruiting
UCLA Medical Center
Los Angeles, California, 90095
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
About this study
Official title: A Multicenter, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sulbactam-Durlobactam in Hospitalized Pediatric Patients From Birth to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Acinetobacter Baumannii-calcoaceticus Complex Infection
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
- Being tested
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours), Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)
- Keywords
- Acinetobacter baumannii-calcoaceticus complex infection, Sulbactam-durlobactam, Hospital-acquired bacteria pneumonia, Ventilator-associated bacterial pneumonia, Acinetobacter, ABC infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)Drug
Also called SUL-DUR
25mg/kg SUL and 25mg/kg DUR
Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours)Drug
Also called SUL-DUR
20mg/kg SUL and 20mg/kg DUR
Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)Drug
Also called SUL-DUR
25mg/kg SUL and 25mg/kg DUR
Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)Drug
Also called SUL-DUR
20mg/kg SUL and 20mg/kg DUR
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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) Receives: Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) |
| Cohort 2 | Experimental | 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) Receives: Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) |
| Cohort 3 | Experimental | Pediatric patients 1 year to <6 years of age Receives: Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) |
| Cohort 4 | Experimental | Pediatric patients 3 months to <1 year of age Receives: Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) |
| Cohort 5 Subgroup 1 | Experimental | 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 Receives: Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours); Drug: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) |
| Cohort 5 Subgroup 2 | Experimental | 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 Receives: Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours); Drug: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam
Measured: Day 1 and Day 3
Assess the PK parameters for area under the plasma concentration-time curve from 0 to 24 hours (AUC 0-24) of sulbactam and durlobactam
Measured: Day 1 and Day 3
Secondary outcomes (14)
Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Defined as any adverse event occurring after exposure to the study drug or any AE that worsens in intensity or frequency
Measured: 28 days
Percentage of TEAEs leading to study drug discontinuation
Measured: 28 days
Incidence of related TEAEs
Measured: 28 days
Incidence of serious TEAEs
Measured: 28 days
Change from baseline values of liver function measured by Comprehensive Metabolic Panel (CMP)
Measured: Baseline and Day 28
Change from baseline values of kidney function measured by CMP
Measured: Baseline and Day 28
Change from baseline values of hemoglobin
Measured: Baseline and Day 28
Change from baseline value of white blood cell count
Measured: Baseline and Day 28
Change from baseline value of platelets
Measured: Baseline and Day 28
Change from baseline value of diastolic blood pressure
Measured: Baseline and Day 28
Change from baseline value of systolic blood pressure
Measured: Baseline and Day 28
Change from baseline values of heart rate
Measured: Baseline and Day 28
Change from baseline value of respiration rate
Measured: Baseline through Day 28
Change from baseline value of temperature
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start30 Dec 2026 (estimated)
- Primary completion5 May 2028 (estimated)
- Study completion20 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innoviva Specialty Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Entasis Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801223
- Sponsor's protocol ID
- CS2514-2023-002
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sulbactam-Durlobactam in Hospitalized Pediatric Patients From Birth to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Acinetobacter Baumannii-calcoaceticus Complex Infection
- ClinicalTrials.gov ID
- NCT06801223
- Acronym / sponsor ID
- CS2514-2023-002
- Keywords
- Acinetobacter baumannii-calcoaceticus complex infection, Sulbactam-durlobactam, Hospital-acquired bacteria pneumonia, Ventilator-associated bacterial pneumonia, Acinetobacter, ABC infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Innoviva Specialty TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Entasis Therapeutics
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (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) |
| Cohort 2 | Experimental | Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)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) |
| Cohort 3 | Experimental | Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)Pediatric patients 1 year to <6 years of age |
| Cohort 4 | Experimental | Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)Pediatric patients 3 months to <1 year of age |
| Cohort 5 Subgroup 1 | Experimental | Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Drug: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours)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 |
| Cohort 5 Subgroup 2 | Experimental | Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours), Drug: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)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 |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient from birth (defined as post-natal age of 7 days) to <18 years of age at the time of written informed consent (and assent, if applicable) and is hospitalized.
- Patient and/or parent(s) or legal guardian(s) have provided the written informed consent and/or assent.
- Patient has confirmed or suspected diagnosis of ABC infection and requires IV antibiotics for treatment.
- Patient has expected survival of 30 days after enrollment in the study.
- If patient is an individual of childbearing potential or reproductive potential, then the patient must remain abstinent OR must utilize one of the highly effective methods of contraception (ie, condom, combined oral contraceptive, implant, or injectable) from at least 30 days prior to screening until at least 30 days after administration of the last dose of study drug.
Key exclusion criteria (21 listed)
- Patient is a preterm infant, born at <28 weeks gestational age.
- Patient has history of significant hypersensitivity or allergic reaction to any β-lactam, any contraindication to the excipients used in the formulation, or any contraindication to the use of β-lactam antibiotics. Note: For β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment.
- Patient is in refractory septic shock at the time of enrollment, defined as persistent hypotension despite adequate fluid resuscitation or vasopressive therapy.
- Patient is pregnant, breastfeeding, or intends to become pregnant.
- Patient is receiving peritoneal dialysis or cardiopulmonary bypass.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)Also: SUL-DUR25mg/kg SUL and 25mg/kg DUR | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 Subgroup 1 |
| Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours)Also: SUL-DUR20mg/kg SUL and 20mg/kg DUR | Drug | Cohort 5 Subgroup 1 |
| Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)Also: SUL-DUR25mg/kg SUL and 25mg/kg DUR | Drug | Cohort 5 Subgroup 2 |
| Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)Also: SUL-DUR20mg/kg SUL and 20mg/kg DUR | Drug | Cohort 5 Subgroup 2 |
Primary outcome
Assess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam
Time frame: Day 1 and Day 3
Assess the PK parameters for area under the plasma concentration-time curve from 0 to 24 hours (AUC 0-24) of sulbactam and durlobactam
Time frame: Day 1 and Day 3
14 secondary outcomes
Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: 28 days
Percentage of TEAEs leading to study drug discontinuation
Time frame: 28 days
Incidence of related TEAEs
Time frame: 28 days
Incidence of serious TEAEs
Time frame: 28 days
Change from baseline values of liver function measured by Comprehensive Metabolic Panel (CMP)
Time frame: Baseline and Day 28
Change from baseline values of kidney function measured by CMP
Time frame: Baseline and Day 28
Change from baseline values of hemoglobin
Time frame: Baseline and Day 28
Change from baseline value of white blood cell count
Time frame: Baseline and Day 28
Change from baseline value of platelets
Time frame: Baseline and Day 28
Change from baseline value of diastolic blood pressure
Time frame: Baseline and Day 28
Change from baseline value of systolic blood pressure
Time frame: Baseline and Day 28
Change from baseline values of heart rate
Time frame: Baseline and Day 28
Change from baseline value of respiration rate
Time frame: Baseline through Day 28
Change from baseline value of temperature
Time frame: Baseline and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
RecruitingObservational study
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) and Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours) in people with Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), run by Innoviva Specialty Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ISTX Clinical Trials (617-715-3600, Clinicaltrials@istx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam (time frame: Day 1 and Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.