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

NCT07552870 | Completed DMC

• 1 other identifier: Nishtar Hospital, Multan
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis

Keywords

cirrhosis; spontaneous bacterial peritonitis; ciprofloxacin

Outcome Measures

Primary Outcomes (1)

• percentage of efficacy

  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

Study Arms (2)

intravenous ciprofloxacin

EXPERIMENTAL

Drug: intravenous ciprofloxacin

intravenous ceftriaxone

PLACEBO COMPARATOR

Drug: intravenous ceftriaxone

Interventions

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 ciprofloxacin

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

intravenous ceftriaxone

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shahida Islam Medical Complex: lead

Study Sites (1)

Nishtar Hospital

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 27, 2026
• Study Start: January 15, 2026
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

PA (1)