Is participation in this San Diego clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) Clinical Trial in San Diego, CA

Q: Is NCT06801223 recruiting in San Diego, CA?

Yes, NCT06801223 is currently recruiting participants at its San Diego, CA location. This acinetobacter baumannii-calcoaceticus complex infection (abc) clinical trial is actively enrolling qualified participants.

Q: How do I join the acinetobacter baumannii-calcoaceticus complex infection (abc) clinical trial in San Diego?

To join this clinical trial in San Diego, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) Study in San Diego

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

Sponsor: Innoviva Specialty Therapeutics

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Diego?

Yes, this clinical trial (NCT06801223) has an active research site in San Diego, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) Treatment Options in San Diego, CA

If you're searching for acinetobacter baumannii-calcoaceticus complex infection (abc) treatment options in San Diego, CA, this clinical trial (NCT06801223) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Diego research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acinetobacter baumannii-calcoaceticus complex infection (abc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acinetobacter baumannii-calcoaceticus complex infection (abc) clinical trials near you to find additional studies recruiting in your area.

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) Clinical Trial in San Diego, CA

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