Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3)

Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3) - BOLT-P3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000054071

Enrollment

210

Registered

2024-04-09

Start date

2024-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cholangitis

Interventions

This study aims to verify that the efficacy of antibiotic treatment for acute cholangitis following biliary drainage in the trial treatment group, lasting 24-72 hours, is not inferior to that in the s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria: 1. Disease: Patients diagnosed with AC in accordance with the TG18, regardless of benign or malignant nature. However, for patients with AC due to dysfunction of distal bile duct stents, inclusion is limited to those who have had a stent in place for more than 30 days. 2. Age: 18 years or older. 3. Previous Treatment: Cases where biliary obstruction has been technically successfully relieved through biliary drainage procedures with ERCP within 48 hours of hospitalization. 4. Consent: Written consent obtained from the patient or their legal representative for participation in this trial.

Exclusion criteria

Exclusion criteria: Circulatory insufficiency with catecholamines at ERCP time. ICU need. Hypothermia below 35 degrees Celsius. Recurrent cholangitis within 3 months. Biliary stricture >= Bismuth 2 or unclear biliary block. Post-surgery anatomical changes like biliary-jejunal anastomosis. Pancreatitis per International Pancreatic Society/American Pancreatic Association: Upper abdominal pain, serum amylase/lipase >3x ULN, acute pancreatitis imaging. Cholecystitis by TG18: A (Murphy's sign/right upper quadrant issues) + B (fever >37.1 degrees Celsius, CRP >3.0 mg/dL, WBC >10,000 uL) + C (acute cholecystitis imaging). Hepatic abscess. Other infections. Pre-registration continuous antibiotics. Pre-registration ERCP complications (perforation, pancreatitis, bleeding, cholecystitis, sedation-related issues). Immunosuppression: A (>10 mg prednisolone), B (HIV), C (neutrophils <=1500 uL), D (recent hematopoietic stem cell transplantation). Pregnancy. Other exclusions by physician.

Design outcomes

Primary

Measure	Time frame
The primary outcome is defined as the rate of cases that achieve clinical cure within 14 days and survive without recurrence.	—

Secondary

Measure	Time frame
The secondary outcomes are as follows: Recurrence rate within 30 days. Mortality rate within 30 days. Total days of antibiotics required for both groups within 30 days. Total days of hospitalization required for both groups within 30 days. Clinical cure rates by severity. Clinical cure rates by fever presence or absence at the end of antibiotic treatment. Clinical cure rates in patients aged 75 and older. Clinical cure rates based on blood culture results. Clinical cure rates based on bile culture results. Clinical cure rates by antibiotic susceptibility prior to ERCP. Clinical cure rates based on antibiotic duration prior to ERCP. Clinical cure rates based on time from admission to ERCP. Clinical cure rates based on the etiology of acute cholangitis (AC). Treatment costs. Incidence of adverse events within 14 days: (a) Rash (b) Diarrhea (three or more loose stools daily) (c) C. difficile enteritis: confirmed by diarrhea (three or more formless stools within 24 hours) and detection of C. difficile toxin A/B in stool or positive stool antigen, culture, or specific genes. (d) Drug-induced liver injury: any of the following: ALT elevation >5 times upper limit of normal (ULN) ALP elevation >2 times ULN ALT >3 times ULN with total bilirubin >2 times ULN Additionally, recurrence is indicated if imaging shows no worsening biliary duct dilation or if hepatic/biliary enzyme levels re-elevate after initially decreasing. (e) Acute kidney injury: if any of the following occur within 48 hours: Increase in serum creatinine by 0.3 mg/dL or more within 48 hours from initial antibiotic administration. Increase in serum creatinine to 1.5 times baseline from initial antibiotic administration until treatment ends. Serum creatinine results will be included from this period, even if measured on non-scheduled days. Baseline is defined as the creatinine value within one year before the trial. If unknown, the lowest value within 7 days before the end	—

Measure

Time frame

The secondary outcomes are as follows: Recurrence rate within 30 days. Mortality rate within 30 days. Total days of antibiotics required for both groups within 30 days. Total days of hospitalization required for both groups within 30 days. Clinical cure rates by severity. Clinical cure rates by fever presence or absence at the end of antibiotic treatment. Clinical cure rates in patients aged 75 and older. Clinical cure rates based on blood culture results. Clinical cure rates based on bile culture results. Clinical cure rates by antibiotic susceptibility prior to ERCP. Clinical cure rates based on antibiotic duration prior to ERCP. Clinical cure rates based on time from admission to ERCP. Clinical cure rates based on the etiology of acute cholangitis (AC). Treatment costs. Incidence of adverse events within 14 days: (a) Rash (b) Diarrhea (three or more loose stools daily) (c) C. difficile enteritis: confirmed by diarrhea (three or more formless stools within 24 hours) and detection of C. difficile toxin A/B in stool or positive stool antigen, culture, or specific genes. (d) Drug-induced liver injury: any of the following: ALT elevation >5 times upper limit of normal (ULN) ALP elevation >2 times ULN ALT >3 times ULN with total bilirubin >2 times ULN Additionally, recurrence is indicated if imaging shows no worsening biliary duct dilation or if hepatic/biliary enzyme levels re-elevate after initially decreasing. (e) Acute kidney injury: if any of the following occur within 48 hours: Increase in serum creatinine by 0.3 mg/dL or more within 48 hours from initial antibiotic administration. Increase in serum creatinine to 1.5 times baseline from initial antibiotic administration until treatment ends. Serum creatinine results will be included from this period, even if measured on non-scheduled days. Baseline is defined as the creatinine value within one year before the trial. If unknown, the lowest value within 7 days before the end

—

Countries

Japan

Contacts

Public ContactSakue Masuda

Shonan Kamakura General Hospital Gastroenterology medicine center

sakue.masuda@tokushukai.jp0467-46-1717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026