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Trial record 74 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia (SMAPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03784365
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Information provided by (Responsible Party):
Mohan Ramchandani, Asian Institute of Gastroenterology, India

Brief Summary:

Achalasia cardia is a primary oesophageal motility disorder of unknown etiology characterized manometrically by oesophageal aperistalsis and insufficient relaxation of the lower oesophageal sphincter (LES) in response to deglutition. Causative mechanism is unknown but may be related to genetic predisposition or autoimmunity.

Because of the unknown aetiology of achalasia, a curative treatment is not available.

Palliative treatment options are aimed to reduce the gradient across the LES, alleviating the primary symptoms of dysphagia and regurgitation, improving esophageal emptying, and preventing the development of megaesophagus.

Condition or disease Intervention/treatment Phase
Achalasia Cardia Drug: 3Rd Generation Cephalosporins Phase 3

Detailed Description:

Treatment modalities include pharmacological therapy, endoscopic injection of botulinum toxin (Botox), pneumatic dilatation (PD), Laparoscopic Heller Myotomy (LHM) and Per Oral Endoscopic Myotomy (POEM). POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). No longer considered as an experimental treatment POEM has achieved remarkable initial outcomes for treating achalasia with approximately 10,000 procedures performed worldwide till date. Numerous studies have focused on the efficacy, safety as well as technical aspects of POEM.

Bacteremia can occur after endoscopic procedures and has been advocated as a surrogate marker for IE risk. The highest rates of bacteremia have been reported with esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts.

However, few efforts have been made to the issue of antimicrobial prophylaxis in POEM. Postoperative prophylactic antibiotics are universally initiated on call to the operating room or at the start of POEM and consist of second-generation cephalosporins. The mean duration of antibiotic regimen after POEM was 3 days ranging from 1 day to 7 days.

Numerous studies have shown that a single dose of antibiotic prophylaxis in a variety of surgical procedures. Few studies have shown that prolonged administration of antibiotics for longer than 24 hours add no benefit in many surgeries. Prolonged use of antibiotics not only increases the costs and exposure to drug toxicity directly but also may be associated with an increased risk of acquired antibiotic resistance as well as infection with Clostridium difficile.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: First group
will receive only one antibiotic(3rd generation cephalosporins) before the procedure
Drug: 3Rd Generation Cephalosporins
Other Name: β-lactam antibiotics

Experimental: Second group
will receive antibiotic(3rd generation cephalosporins) for three subsequent days.Post POEM procedure,blood cultures were drawn after 6hour of procedure and Day 3.
Drug: 3Rd Generation Cephalosporins
Other Name: β-lactam antibiotics

Primary Outcome Measures :
  1. estimate the % of bacteremia associated with POEM. [ Time Frame: 1 month ]
    The primary outcome of the study is to estimate the % of bacteremia associated with POEM.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All the patient(aged 18-65) who underwent POEM for achalasia cardia.

Exclusion Criteria:

  • Unwillingness to give written informed consent

    • Patients with multiple co morbidities.
    • Immunocompromised patients /on steroid therapy.
    • Patients with indications for antibiotic prophylaxis (infective endocarditis).
    • Patients who have received antibiotics in the last 1 week .
    • Patients who have possible signs of infection during preparation for POEM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03784365

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Contact: Bhushan Bhaware 9833022139

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Dr.Mohan Ramchandani Recruiting
Hyderabad, RED ROSE Restaurant, India, 500082
Contact: Mohan Ramchandani    8297918513   
Contact: Zaheer Nabi    9573058810   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
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Principal Investigator: Mohan Ramchandani Asian Institute of Gastroenterology, Hyderabad, India

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Responsible Party: Mohan Ramchandani, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India Identifier: NCT03784365     History of Changes
Other Study ID Numbers: SMAPP-01
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohan Ramchandani, Asian Institute of Gastroenterology, India:
oesophageal aperistalsis
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases