Comparison of 3 Days and 7 Days Intravenous Ceftriaxone Prophylaxis for Variceal Bleeding

NCT00838864 | Completed Phase 4 DMC

• 1 other identifier: FEMH-97-C-010
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Prophylactic antibiotics have been routinely recommended for cirrhotic patients with upper gastrointestinal bleeding recently. However, the regimen and duration of its use remain an inconclusive issue. Quinolones and 3rd generation cephalosporins have been more often used for prophyalxis recently. The duration for antibiotic usage were variable in the literatures, ranged from 4-10 days. The latest guideline from AASLD in 2007 was 7 days. In the survey of infections in cirrhotic patients with UGI bleeding performed by Bernard et al, most infections occurred in the first 5 days and half within the first 48 hours. Therefore, considering the cost-effectiveness and drug resistance issues, the necessity for such prophylaxis for 7 days may need to be re-evaluated. The purpose of our study is to investigate the antibiotic prophylaxis duration for cirrhotic patients with acute gastro-esophageal variceal bleeding. We will enroll those patients suffering from variceal bleeding documented by endoscopic examination and without apparent evidence of infection. Those who have received antibiotics within 2 weeks, are less than 18 years old, get pregnant, have malignancy other than HCC, have allergy to ceftrioxone are excluded. After receiving well explanation and giving consent, these patients are randomly allocated to 2 groups and receive prophylactic antibiotic just after endoscopic examination; Group I: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 3 days, Group II: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 7 days. They will receive appropriate endoscopic treatment for gastro-esophgeal varices and glypressin 1mg q6h for 3 days. They will start to feed on the 2nd day if not contraindicated. The 2nd endoscopic treatment for varices will be performed 2 weeks later. We record the demographic data, vital signs, transfusion amount; check hemogram, U/A, CXR, ascites routine (with apparent ascites), classification of variceal size and Child-Pugh classification. We monitor the events of rebleeding \& infection, transfusion amount and hospitalization days We use rebleeding rate within 14 days as the primary end point. It is defined as the following events after initial stabilization of vital signs for 24 hours; (1): recurrence of hematemesis or bloody stool (2); need of transfusion more than 2 unit of blood and systolic pressure \< 100 mmHg or pulse rate \> 100/mn. We use infection rate during admission and mortality rate within 28 days as secondary end points.

Conditions

Esophageal and Gastric Varices; Gastrointestinal Hemorrhage

Keywords

variceal bleeding; antibiotic prophylaxis; ceftrioxone

Outcome Measures

Primary Outcomes (1)

• rebleeding rate within 14 days

  14 days

Secondary Outcomes (1)

• motarlity rate within 28 days

  28 days

Study Arms (2)

1

ACTIVE COMPARATOR

ceftrioxone 500mg q12h for 3 days

Drug: ceftrioxone

2

ACTIVE COMPARATOR

ceftrioxone 500 mg q12h for 7 days

Drug: ceftrioxone

Interventions

ceftrioxone DRUG

500 mg iv q12h for 3 days

Also known as: Rocephin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• those patients suffering from variceal bleeding documented by endoscopic examination and without apparent evidence of infection.

You may not qualify if:

• received antibiotics within 2 weeks, less than 18 years old, get pregnant, have malignancy other than HCC, have allergy to ceftrioxone

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 22050, Taiwan

Location

Related Publications (16)

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  PMID: 3489499 BACKGROUND

• Bernard B, Cadranel JF, Valla D, Escolano S, Jarlier V, Opolon P. Prognostic significance of bacterial infection in bleeding cirrhotic patients: a prospective study. Gastroenterology. 1995 Jun;108(6):1828-34. doi: 10.1016/0016-5085(95)90146-9.

  PMID: 7768389 BACKGROUND

• Bernard B, Grange JD, Khac EN, Amiot X, Opolon P, Poynard T. Antibiotic prophylaxis for the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding: a meta-analysis. Hepatology. 1999 Jun;29(6):1655-61. doi: 10.1002/hep.510290608.

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  PMID: 11786970 BACKGROUND

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  PMID: 17727436 BACKGROUND

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  PMID: 16201103 BACKGROUND

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  PMID: 15816474 BACKGROUND

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  PMID: 17043424 BACKGROUND

• Soriano G, Guarner C, Tomas A, Villanueva C, Torras X, Gonzalez D, Sainz S, Anguera A, Cusso X, Balanzo J, et al. Norfloxacin prevents bacterial infection in cirrhotics with gastrointestinal hemorrhage. Gastroenterology. 1992 Oct;103(4):1267-72. doi: 10.1016/0016-5085(92)91514-5.

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  PMID: 16247523 BACKGROUND

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  PMID: 15086198 BACKGROUND

• Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.

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  PMID: 16148557 BACKGROUND

• Fernandez J, Ruiz del Arbol L, Gomez C, Durandez R, Serradilla R, Guarner C, Planas R, Arroyo V, Navasa M. Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage. Gastroenterology. 2006 Oct;131(4):1049-56; quiz 1285. doi: 10.1053/j.gastro.2006.07.010.

  PMID: 17030175 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices; Gastrointestinal Hemorrhage

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tzong-Hsi Lee, M.D.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 31, 2015

Record last verified: 2009-01

Locations

TW (1)