Trial Outcomes & Findings for Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use (NCT NCT05521880)

Results Overview

One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. So cure or completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks could not be assessed, and no statistical analyses were performed.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-07-24

Participant Flow

One patient screen failed and one patient opted out of the study after initial visit

Participant milestones

Participant milestones
Measure	Study Arm One patient screen failed and one patient opted out of the study after initial visit	Historical Outcomes With Standard of Care Treatment Historical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant was enrolled but withdrew after the initial visit before baseline assessments were completed. Therefore, no evaluable baseline characteristic data were available.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 weeks

Population: Because no participant completed study visits to timeline where outcomes could be assessed this cannot be reported

One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. So cure or completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks could not be assessed, and no statistical analyses were performed.

Outcome measures

Outcome measures
Measure	Historical Outcomes With Standard of Care Treatment Historical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared. Because no participant completed study visits to timeline where outcomes could be assessed this cannot be reported	Study Arm One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Frequency of Clinically Assessed Cure, Completion (no Need for Further Parenteral Antimicrobial Therapy) or Transition to Suppressive Antimicrobial Therapy at 12 Weeks	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. Consequently, no participants contributed evaluable data for this outcome measure, and no statistical analyses were performed.

One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. Consequently, no participants contributed evaluable data(Frequency of non-adherence to antimicrobial therapy) for this outcome measure, and no statistical analyses were performed.