Intravenous Ciprofloxacin Versus Intravenous Ceftriaxone: Spontaneous Bacterial Peritonitis in Cirrhosis of Liver

April 22, 2026 updated by: Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex

Comparison of Intravenous Ciprofloxacin and Intravenous Ceftriaxone in the Management of Spontaneous Bacterial Peritonitis in Cirrhosis of Liver

Spontaneous bacterial peritonitis (SBP) is one of the leading causes of morbidity and mortality in patients with cirrhosis. Spontaneous bacterial peritonitis (SBP) is a common bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30%1. Early diagnosis and a prompt antibiotic therapy have considerably decreased the mortality rate associated with an episode of SBP from 80% to approximately 20- 30% in the last decade. It is secondary to impaired humoral and cellular immune responses that results in indirect intestinal bacterial translocation into the ascitic fluid 2,3. The incidence of spontaneous bacterial peritonitis in hospitalised patients with cirrhosis varies from 7-23% in the West. It is around 33% in Pakistan. Translocation of bacteria (mostly gram negative) from the intestinal lumen due to decreased phagocytic activity of macrophages and increased intestinal permeability in cirrhotic patients is an important step in the development of spontaneous bacterial peritonitis. Spontaneous bacterial peritonitis is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent attention drawn to the changing microbial and resistance patterns attributed to the increasing use of antibiotic prophylaxis and invasive procedures in such patients further underscores the importance of identifying the causative pathogen to ensure adequate antibiotic coverage 5,6. Symptomatic spontaneous bacterial peritonitis can be present as first presentation of ascites in chronic liver

Page | 4disease patients7. Patients with spontaneous bacterial peritonitis has a mortality rate ranging between 30-50%8 early diagnosis and prompt treatment with antibiotic can save patients lives9.

Different options in antibiotics are ceftriaxone, cefotaxime, ampicillin, ciprofloxacin, ofloxacin and metronidazole. Cefotaxime or ceftriaxone were considered the first-choice antibiotic for empirical treatment in cirrhotic patients developing spontaneous bacterial peritonitis. It has been suggested that ciprofloxacin could be an alternative to cefotaxime or ceftriaxone in cirrhotic patients developing spontaneous bacterial peritonitis 7

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • Nishtar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient diagnosed with spontaneous bacterial peritonitis:

Child Pugh class A, B and C, confirmed from record file of the patient. Male and female patients from the age of 25-70 years with liver cirrhosis

Exclusion Criteria:

  • Hemorrhagic or malignant ascites. (on history).
  • Tuberculous with secondary peritonitis (on medical record file).
  • Hepatocellular carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intravenous ciprofloxacin
Drug: intravenous ciprofloxacin
In group A, 155 patients will be given intravenous ciprofloxacin 200mg 12 hourly. Treatment will be given for consecutive 48 hours. Ascitic fluid tap will be done before and then 48 hours after the antibiotic initiation by the researcher himself and sent to the hospital laboratory. Total duration of treatment will be of 5 days9and efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, resolution of abdominal pain, determining the ascitic fluid neutrophil count after 48 hours
Placebo Comparator: intravenous ceftriaxone
Drug: intravenous ceftriaxone
in group B 155 patients on ceftriaxone 1g 12 hourly. Treatment will be given for consecutive 48 hours. Ascitic fluid tap will be done before and then 48 hours after the antibiotic initiation by the researcher himself and sent to the hospital laboratory. Total duration of treatment will be of 5 days9and efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, resolution of abdominal pain, determining the ascitic fluid neutrophil count after 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of efficacy
Time Frame: 1 month

efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, absence of abdominal pain, reduction of the ascitic fluid neutrophil count to <250 cells /mm³ after 48 hours of antibiotic therapy.

Fever : Oral temperature >38° C measured using a digital thermometer
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahida Islam Medical Complex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Actual)

April 14, 2026

Study Completion (Actual)

April 14, 2026

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nishtar Hospital, Multan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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