Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2021/05/033535
CTRI/2021/05/033535
Completed
Phase 3

To compare short course antibiotic therapy with conventional antibiotic therapy after successful biliary drainage in patients with moderate to severe acute cholangitis: Single centre, randomised, non-inferiority trial - SCINAC

ot applicable0 sites120 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: K830- Cholangitis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: K830- Cholangitis
Sponsor
ot applicable
Enrollment
120
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
June 10, 2022
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with age18 years or older.
  • •2\. Patients diagnosed as having moderate to severe acute cholangitis according to Tokyo guidelines 2018\.
  • •3\. Patients underwent successful biliary drainage via procedures like ERCP, EUS\-guided drainage and PTBD.

Exclusion Criteria

  • •1\. The patients not willing to participate in the study.
  • •2\. When incomplete biliary drainage is suspected (Patient with primary sclerosing cholangitis or portal cavernoma cholangiopathy with multiple intrahepatic biliary stricture or complex hilar stricture like Bismuth type III or IV).
  • •3\. Moribund patient like patients requiring ventilatory support or patients with Glasgow coma scale of less 8\.
  • •4\. Patients with associated or cholangitis related complication which requires longer antibiotics (like liver abscess, acute cholecystitis or metastatic complications like infective endocarditis, pneumonia or septic arthritis at the time of diagnosis).
  • •6\. Immunocompromised patients like patients who receiving cancer chemotherapy, steroids (Prednisolone \>10mg/d), or immunosuppressive agents.
  • •7\. Blood or bile culture grew fungus.
  • •8\.Patients with concomitant acute pancreatitis and other infections elsewhere in the body which requires longer hospitalization and/or antibiotics.
  • •9\. Pregnant females.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trialinfective endocarditisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2019-003358-10-ESCarmen Olmos Blanco298
Active, not recruiting
Phase 1
Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.Febrile neutropeniaMedDRA version: 19.1Level: PTClassification code 10063581Term: Stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.1Level: LLTClassification code 10002969Term: Aplastic anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.1Level: LLTClassification code 10003999Term: BacteremiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: LLTClassification code 10028566Term: MyelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10062957Term: Catheter bacteraemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10056520Term: Catheter site infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
EUCTR2014-001546-25-NLVU University Medical Center240
Completed
Phase 4
Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial.febrile neutropenia1001886510004018
NL-OMON47609VUmc276
Not yet recruiting
Phase 3
Comparing long and short duration antibiotics for abdominal infectionsHealth Condition 1: null- Complicated Intra-abdominal Infections
CTRI/2018/03/012682Jawaharlal Institute of PostGraduate Medical Education and Research
Recruiting
Not Applicable
Short term antibiotic therapy in Patients with cholangitis and complete biliary drainage: A prospective multicenter trialK83.0Cholangitis
DRKS00021237Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main105