NCT04240288

Procalcitonin Guided Antibiotic Therapy

Randomized Controlled Trial of Procalcitonin-Guided Antibiotic Therapy Versus Standard of Care for Complicated Intra-Abdominal Infections

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A 2019 Centers for Disease Control (CDC) report describes the rate of antibiotic resistance as alarmingly high and says clinicians must make efforts to lower the development of resistance through more discerning antibiotic use. Complicated intra-abdominal infections (CIAIs), defined as an infection that extends beyond the hollow viscus of origin and into the peritoneal space, are a common problem with a 9.2% mortality rate worldwide, a morbidity of 5-50% and a 21.5% risk of extra-abdominal infections. The basic principles for treatment of CIAIs include source control and appropriate antibiotic coverage; however, source control cannot always be achieved in CIAIs, i.e. diverticular or appendiceal abscesses. The STOP-IT trial concluded that shorter courses of antibiotics for CIAIs with source control are equivalent to the traditional longer courses with regard to recurrent infections and mortality, even in the setting of sepsis, but the optimal duration of antibiotic treatment is unknown for patients with CIAIs without source control. Due to lack of guidelines, these patients are routinely treated with long antibiotic courses. Given the association of prolonged antibiotic courses and increased rates of post-treatment infectious complications and antimicrobial resistance, the Infectious Disease Society of America and the Surgical Infection Society acknowledge that there is an urgent need to study the appropriate duration of antimicrobial therapy for CIAIs. The biomarker procalcitonin is expressed by human epithelial cells in response to bacterial infections, distinguishes true bacterial infection from Systemic Inflammatory Response Syndrome (SIRS) and has been used in studies to identify CIAIs. Procalcitonin-guided antibiotic management has been shown to decrease the number of antibiotic days in respiratory infections and reduce mortality among medical and surgical Intensive Care Unit (ICU) populations (including those with CIAIs). However, there is little data evaluating its role in guiding antibiotic therapy specifically for CIAIs.

Conditions

• Intra-Abdominal Infections

Interventions

Type	Name	Description
OTHER	Procalcitonin-guided antibiotic treatment	Antibiotics will be administered based on the procalcitonin lab results.
OTHER	Standard of Care Antibiotic Treatment	Antibiotics will be administered based on standard of care treatment. The treating physicians will determine the treatment course.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-01-27
• Last updated: 2021-10-21