Intra-Abdominal InfectionsNCT04240288
Procalcitonin Guided Antibiotic Therapy
A study testing Procalcitonin-guided antibiotic treatment in people with Intra-Abdominal Infections, run by Columbia University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Infections
- What is being tested?
- Procalcitonin-guided antibiotic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Ability to give consent in English or Spanish
- Imaging proven intra-abdominal infection (CT, US, and/or MRI)
Who cannot join
- 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
Show all 16Show fewer
- 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
- Patients with another infection (e.g., pneumonia, urinary tract infection) that requires treatment with another antibiotic
About this study
Official title: Randomized Controlled Trial of Procalcitonin-Guided Antibiotic Therapy Versus Standard of Care for Complicated Intra-Abdominal Infections
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.
Read the 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
- Being tested
- Procalcitonin-guided antibiotic treatment, Standard of Care Antibiotic Treatment
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin-guided antibiotic treatmentOther
Antibiotics will be administered based on the procalcitonin lab results.
Standard of Care Antibiotic TreatmentOther
Antibiotics will be administered based on standard of care treatment. The treating physicians will determine the treatment course.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Procalcitonin-guided antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 days
Secondary outcomes (1)
Total Number of Recurrent Intra-Abdominal Infections or Extra-Abdominal Infections
To describe the rate of recurrent intra-abdominal infections in both the procalcitonin-guided antibiotic therapy arm and the control group. This will serve as a secondary outcome as well as a safety endpoint. We will describe the rate of antibiotic failure at 30 days, the 30-day mortality and the rate of extra-abdominal infections.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startSep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Fischkoff, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240288
- Sponsor's protocol ID
- AAAS5105
- Status last verified
- Oct 2021
- First submitted
- 22 Jan 2020
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Procalcitonin-Guided Antibiotic Therapy Versus Standard of Care for Complicated Intra-Abdominal Infections
- ClinicalTrials.gov ID
- NCT04240288
- Acronym / sponsor ID
- AAAS5105
- Conditions
- Intra-Abdominal Infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Other: Standard of Care Antibiotic TreatmentParticipants 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. |
| Treatment Arm | Experimental | Other: Procalcitonin-guided antibiotic treatmentThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Ability to give consent in English or Spanish
- Imaging proven intra-abdominal infection (CT, US, and/or MRI)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin-guided antibiotic treatmentAntibiotics will be administered based on the procalcitonin lab results. | Other | Treatment Arm |
| Standard of Care Antibiotic TreatmentAntibiotics will be administered based on standard of care treatment. The treating physicians will determine the treatment course. | Other | Control Arm |
Primary outcome
Total Number of Antibiotic Treatment Days
Time frame: Up to 10 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.
1 secondary outcome
Total Number of Recurrent Intra-Abdominal Infections or Extra-Abdominal Infections
Time frame: Day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Fischkoff, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin-guided antibiotic treatment in people with Intra-Abdominal Infections, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Antibiotic Treatment Days (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.