Achalasia CardiaPhase 3SMAPPNCT03784365
Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
A Phase 3 study testing One dose of Cefo-perazone Sulbactum in people with Achalasia Cardia, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia. Major adverse events are uncommon with POEM. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achalasia Cardia
- What is being tested?
- One dose of Cefo-perazone Sulbactum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to Mar 2020
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patient(aged 18-65) who underwent POEM for achalasia cardia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr.Mohan Ramchandani
Hyderabad, RED ROSE Restaurant, 500082
Mohan Ramchandani, 8297918513, ramchandanimohan@gmail.com
Zaheer Nabi, 9573058810, zaheernabi1978@gmail.com
About this study
Official title: Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia.
Major adverse events are uncommon with POEM. Since the operator works close to mediastinum during the POEM procedure, there is a potential for infectious complications. Therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. There is no fixed protocol or duration of antibiotics for the same.
Read the detailed description
POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are rare and therefore, the procedure is considered safe.
Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a surrogate marker for risk of infection-related complications. In POEM procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the potential for infection-related complications is high. However, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. At present, prophylactic antibiotics are universally initiated before starting the POEM procedure and continued for a variable duration after POEM ranging from 1 day to 7 days.
Data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. 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.
With this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing POEM.
- Conditions
- Achalasia Cardia
- Being tested
- One dose of Cefo-perazone Sulbactum
- Keywords
- oesophageal aperistalsis
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One dose of Cefo-perazone SulbactumDrug
Also called Multiple doses of Cefo-perazone Sulbactum
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| First group | Active comparator | This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure. Receives: Drug: One dose of Cefo-perazone Sulbactum |
| Second group | Experimental | This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure Receives: Drug: One dose of Cefo-perazone Sulbactum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complications associated with POEM
The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups
Measured: 1 month
Secondary outcomes (5)
Incidence of positive blood cultures
The main secondary outcome is difference in the incidence of positive blood cultures between the two groups
Measured: 72 hours
Comparison of serum Procalcitonin between the two groups
Difference in the mean serum procalcitonin values between both the groups
Measured: 72 hours
Comparison of inflammatory markers (CRP) between the two groups
Both the groups will be compared for mean blood C-reactive protein (CRP)
Measured: 72 hours
Comparison of erythrocyte sedimentation rate (ESR) between the two groups
Both the groups will be compared for mean ESR at 1-hour
Measured: 72 hours
Adverse events associated with administration of intravenous antibiotics
Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Dec 2018
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Ramchandani, Principal investigator, Asian Institute of Gastroenterology, Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784365
- Sponsor's protocol ID
- SMAPP-01
- Acronym
- SMAPP
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nabi Z, Bhaware B, Ramchandani M, Basha J, Inavolu P, Kotla R, Goud R, Darisetty S, Reddy DN. Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study (SMAPP Trial). Dysphagia. 2023 Dec;38(6):1581-1588. doi: 10.1007/s00455-023-10585-y. Epub 2023 May 4.
PubMed 37142733
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
- ClinicalTrials.gov ID
- NCT03784365
- Acronym / sponsor ID
- SMAPP / SMAPP-01
- Conditions
- Achalasia Cardia
- Keywords
- oesophageal aperistalsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 21 Dec 2018 (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.
Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia.
Major adverse events are uncommon with POEM. Since the operator works close to mediastinum during the POEM procedure, there is a potential for infectious complications. Therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. There is no fixed protocol or duration of antibiotics for the same.
Detailed description
POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are rare and therefore, the procedure is considered safe.
Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a surrogate marker for risk of infection-related complications. In POEM procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the potential for infection-related complications is high. However, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. At present, prophylactic antibiotics are universally initiated before starting the POEM procedure and continued for a variable duration after POEM ranging from 1 day to 7 days.
Data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. 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.
With this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing POEM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group | Active comparator | Drug: One dose of Cefo-perazone SulbactumThis group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure. |
| Second group | Experimental | Drug: One dose of Cefo-perazone SulbactumThis group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the patient(aged 18-65) who underwent POEM for achalasia cardia.
Key exclusion criteria (6 listed)
- Unwillingness to give written informed consent
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 |
|---|---|---|
| One dose of Cefo-perazone SulbactumAlso: Multiple doses of Cefo-perazone SulbactumAntibiotic | Drug | First group, Second group |
Primary outcome
Infectious complications associated with POEM
Time frame: 1 month
The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups
5 secondary outcomes
Incidence of positive blood cultures
Time frame: 72 hours
Comparison of serum Procalcitonin between the two groups
Time frame: 72 hours
Comparison of inflammatory markers (CRP) between the two groups
Time frame: 72 hours
Comparison of erythrocyte sedimentation rate (ESR) between the two groups
Time frame: 72 hours
Adverse events associated with administration of intravenous antibiotics
Time frame: 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 37142733Nabi Z, Bhaware B, Ramchandani M, Basha J, Inavolu P, Kotla R, Goud R, Darisetty S, Reddy DN. Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study (SMAPP Trial). Dysphagia. 2023 Dec;38(6):1581-1588. doi: 10.1007/s00455-023-10585-y. Epub 2023 May 4.
Related trials for Achalasia Cardia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
Achalasia Cardia, Achalasia
RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
RecruitingPhase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Achalasia
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.
Mohan Ramchandani principal investigator
Asian Institute of Gastroenterology, Hyderabad, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing One dose of Cefo-perazone Sulbactum in people with Achalasia Cardia, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bhushan Bhaware (9833022139, drbhushanbhaware3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complications associated with POEM (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784365, which also lists 1 linked publication.
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 18 Jan 2020.