Skip to main content
OpenTrials
Completed

NCT Number: NCT07552870

Intravenous Ciprofloxacin Versus Intravenous Ceftriaxone: 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Hospital

Multan, Punjab Province, 60000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous ciprofloxacin

Drug

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

intravenous ceftriaxone

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shahida Islam Medical Complex

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.