Procalcitonin Guided Antibiotic Therapy

NCT04240288 | Withdrawn

• 1 other identifier: AAAS5105
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overuse of antibiotics is an enormous problem facing the healthcare system both in the United States and across the world. The investigators plan to test the hypothesis that using procalcitonin levels (blood test) to guide the length of antibiotic therapy in patients with complicated intra-abdominal infections leads to shorter antibiotic treatment courses.

Conditions

Intra-Abdominal Infections

Outcome Measures

Primary Outcomes (1)

• Total Number of Antibiotic Treatment Days

  The total number of antibiotic treatment days will be calculated for participants in both arms. Patients in the experimental arm will have their antibiotics stopped when the procalcitonin drops to ≤80% of its index value or to \<0.5 ng/ml.

  Up to 10 days

Secondary Outcomes (1)

• Total Number of Recurrent Intra-Abdominal Infections or Extra-Abdominal Infections

  Day 30

Study Arms (2)

Control Arm

OTHER

Participants randomized to the control arm will be managed with the current standard of care including daily white blood cell count and vital sign documentation. The control group will also have daily procalcitonin levels drawn but the results will not be used to make decisions regarding antibiotic duration. Antibiotics will be given orally or intravenously at the discretion of the treating physician and will be given for a 10-day course, the current standard of care.

Other: Standard of Care Antibiotic Treatment

Treatment Arm

EXPERIMENTAL

These participants will be managed with procalcitonin-guided antibiotic therapy. An index procalcitonin will be drawn within 24 hours of admission followed by daily procalcitonin levels. Per standard of care, patients will have daily white blood cell counts drawn and regular vital sign documentation. Antibiotics will be given orally or intravenously at the discretion of the treating physician. Antibiotics in this arm will be stopped once the procalcitonin value drops to ≤80% of its index value or to \<0.5 ng/ml. Extension of antibiotics for more than 24 hours past this time will be documented.

Other: Procalcitonin-guided antibiotic treatment

Interventions

Procalcitonin-guided antibiotic treatment OTHER

Antibiotics will be administered based on the procalcitonin lab results.

Treatment Arm

Standard of Care Antibiotic Treatment OTHER

Antibiotics will be administered based on standard of care treatment. The treating physicians will determine the treatment course.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Ability to give consent in English or Spanish
• Imaging proven intra-abdominal infection (CT, US, and/or MRI)

You may not qualify if:

• Unable to give informed consent
• Patients enrolled in another trial
• Those having surgery for source control
• Patients with anastomotic leak
• Unable or unwilling to return or be contacted for clinical follow-up visits
• Currently incarcerated in a detention facility or in police custody
• Conditions with altered immune response or at risk for bacterial seeding
• Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive drugs, active chemotherapy or plans for chemotherapy in the following 30 days, or known AIDS \[CD4 count \<200 or AIDS-defining illness within the last year\] assessed by patient history)
• Uncompensated liver failure
• Taking medication to treat active inflammatory bowel disease
• Malignancy, not in remission (ongoing chemotherapy patients excluded)
• Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening
• Expected concurrent hemodialysis, peritoneal dialysis, or treatments using indwelling venous catheters
• Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve)
• Indwelling Left Ventricular Assist Device

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Katherine Fischkoff, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. The study is unblinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: October 21, 2021

Record last verified: 2021-10