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NCT06801223 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
A Phase 1 study of Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), sponsored by Innoviva Specialty Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 4
- Study locations
NCT06801223 is a Phase 1 study of Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) that is actively recruiting participants, run by Innoviva Specialty Therapeutics. The registered enrollment target is 48 participants. The trial reports 4 study locations across 3 states.
The verdict
NCT06801223, a Phase 1 study of Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), is actively recruiting participants, sponsored by Innoviva Specialty Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 4
- Study locations
Study 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 (ABC) infections
Conditions Studied
Interventions
- DRUG Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)
- DRUG Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours)
- DRUG Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)
- DRUG Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)
Study Locations (4)
California
- UCLA Medical Center - Los Angeles
- Rady Children's Hospital - San Diego
North Carolina
- ECU Brody School of Medicine - Greenville
Texas
- University of Texas Medical Branch at Galveston - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-10-30 |
| Est. Completion | 2028-05-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06801223
The ClinicalTrials.gov registry entry for NCT06801223 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innoviva Specialty Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) appearing as the primary indexed condition, and to 4 interventions - of which Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) is the first listed.
NCT06801223 reports 4 study locations spanning 3 distinct geographic areas - top geographies include California, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06801223 about?
NCT06801223 is a clinical study titled "A Study to Assess Sulbactam-durlobactam in Pediatric Patients With 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-ca...
What is the current status of trial NCT06801223?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-10-30. Estimated completion is 2028-05-20.
What conditions does trial NCT06801223 study?
This clinical trial studies the following conditions: Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC).
What interventions are being tested in trial NCT06801223?
The interventions under investigation include: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) (DRUG), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) (DRUG), Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours) (DRUG), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) (DRUG).
Who is sponsoring clinical trial NCT06801223?
This trial is sponsored by Innoviva Specialty Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06801223 being conducted?
This trial has 4 study locations across California, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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