Acute CholangitisNCT03422042
Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
A study testing Short duration of antibiotic and Standard treatment of antibiotic in people with Acute Cholangitis and Common Bile Duct Calculi, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholangitis, Common Bile Duct Calculi
- What is being tested?
- Short duration of antibiotic and Standard treatment of antibiotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 13 Aug 2017to 30 Aug 2019
- 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
- age ≥ 18 years old
- diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis
- endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission
Who cannot join
- pregnant woman
- the cause of obstruction other than common bile duct stone
- severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease
- active concomitant infections of other organs
- history of allergy to cephalosporin group
Trial locations and contacts
1 site in 1 country.
Thailand1 site
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: An Open-labeled, Randomized Controlled Trial Comparing Between Short Duration And Standard Fourteen Days Antibiotic Treatments In Patients With Acute Common Bile Duct Stone Cholangitis After Successful Endoscopic Biliary Drainage
Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.
Read the detailed description
The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.
The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
- Conditions
- Acute Cholangitis, Common Bile Duct Calculi
- Being tested
- Short duration of antibiotic, Standard treatment of antibiotic
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short duration of antibioticOther
Also called G1
Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.
Standard treatment of antibioticOther
Also called G2
Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
| Study group | Role | What they receive |
|---|---|---|
| Short duration of antibiotic | Active comparator | group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued Receives: Other: Short duration of antibiotic |
| Standard treatment of antibiotic | Active comparator | group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature Receives: Other: Standard treatment of antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of cholangitis
The number of patients who has recurrence of fever after complete treatment without other sources identified
Measured: 8 weeks
Secondary outcomes (3)
The rate of adequacy of drainage
The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct.
Measured: 24 hours
Complication rate
The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications.
Measured: 4 weeks
Mortality rate
The number of patient with death
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start13 Aug 2017
- Primary completion20 Feb 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholangitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Nisa Netinatsunton, MD., Principal investigator, NKC Institute of Gastroenterology and Hepatology.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422042
- Sponsor's protocol ID
- REC 56-124-21-1-2
- Status last verified
- Nov 2017
- First submitted
- 30 Jan 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled, Randomized Controlled Trial Comparing Between Short Duration And Standard Fourteen Days Antibiotic Treatments In Patients With Acute Common Bile Duct Stone Cholangitis After Successful Endoscopic Biliary Drainage
- ClinicalTrials.gov ID
- NCT03422042
- Acronym / sponsor ID
- REC 56-124-21-1-2
- Conditions
- Acute Cholangitis, Common Bile Duct Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 13 Aug 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Feb 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.
Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.
Detailed description
The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.
The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short duration of antibiotic | Active comparator | Other: Short duration of antibioticgroup A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued |
| Standard treatment of antibiotic | Active comparator | Other: Standard treatment of antibioticgroup B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years old
- diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis
- endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission
Key exclusion criteria (5 listed)
- pregnant woman
- the cause of obstruction other than common bile duct stone
- severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease
- active concomitant infections of other organs
- history of allergy to cephalosporin group
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 |
|---|---|---|
| Short duration of antibioticAlso: G1Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued. | Other | Short duration of antibiotic |
| Standard treatment of antibioticAlso: G2Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature. | Other | Standard treatment of antibiotic |
Primary outcome
The recurrence rate of cholangitis
Time frame: 8 weeks
The number of patients who has recurrence of fever after complete treatment without other sources identified
3 secondary outcomes
The rate of adequacy of drainage
Time frame: 24 hours
Complication rate
Time frame: 4 weeks
Mortality rate
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No. The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient
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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.
Nisa Netinatsunton, MD. principal investigator
NKC Institute of Gastroenterology and Hepatology.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short duration of antibiotic and Standard treatment of antibiotic in people with Acute Cholangitis and Common Bile Duct Calculi, run by Prince of Songkla University at 1 site in Thailand.
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 5 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: finished, as of the sponsor's last update on 4 Mar 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 Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The recurrence rate of cholangitis (time frame: 8 weeks). 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 4 Mar 2020.