- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750385
Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: To elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM are randomized to either use antibiotic prophylactically or not.
Main outcome measurements: Blood culture positive incidence; secondary outcomes are procalcitonin levels, C-reactive protein levels, white blood cell counts and so on.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of esophageal achalasia
- Ready to have the treatment as POEM and no contraindication of POEM
- Ability to get informed consent
Exclusion Criteria:
- Patients who had indications for antibiotic prophylaxis as determined by the American Society for Gastrointestinal Endoscopy
- Patients who had received antibiotics for any reason within the previous 7days
- Patients who had possible signs of any infection at the time of the procedure
- Patients who had chronic inflammatory diseases need hormonotherapy : such as rheumatic arthritis or inflammatory bowel diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: no antibiotic prophylaxis
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
|
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
|
Active Comparator: second-generation cephalosporin
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
|
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood culture positive incidence
Time Frame: after 12 hours of POEM
|
To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.
|
after 12 hours of POEM
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
procalcitonin level
Time Frame: after 12 hours of POEM
|
To observe the changes of procalcitonin levels after POEM in which no antibiotic is administered. To compare the procalcitonin levels between antibiotic prophylaxis and no antibiotic prophylaxis. |
after 12 hours of POEM
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical manifestation
Time Frame: during hospital stay and up to 1 week
|
To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period.
|
during hospital stay and up to 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ping-Hong Zhou, M.D,PhD, Fudan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Gastrointestinal Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sepsis
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Bacteremia
- Esophageal Achalasia
- Anti-Infective Agents
- Anti-Bacterial Agents
- Cephalosporins
Other Study ID Numbers
- B2012-089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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