CirrhosisNCT07552870
Intravenous Ciprofloxacin Versus Intravenous Ceftriaxone: Spontaneous Bacterial Peritonitis in Cirrhosis of Liver
A study testing intravenous ciprofloxacin and intravenous ceftriaxone in people with Cirrhosis, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- intravenous ciprofloxacin and intravenous ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2026to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemorrhagic or malignant ascites. (on history).
- Tuberculous with secondary peritonitis (on medical record file).
- Hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Cirrhosis
- Being tested
- intravenous ciprofloxacin, intravenous ceftriaxone
- Keywords
- cirrhosis, spontaneous bacterial peritonitis, ciprofloxacin
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous ciprofloxacinDrug
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 ceftriaxoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| intravenous ciprofloxacin | Experimental | Not described Receives: Drug: intravenous ciprofloxacin |
| intravenous ceftriaxone | Placebo comparator | Not described Receives: Drug: intravenous ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 Jan 2026
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552870
- Sponsor's protocol ID
- Nishtar Hospital, Multan
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Ciprofloxacin and Intravenous Ceftriaxone in the Management of Spontaneous Bacterial Peritonitis in Cirrhosis of Liver
- ClinicalTrials.gov ID
- NCT07552870
- Acronym / sponsor ID
- Nishtar Hospital, Multan
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, spontaneous bacterial peritonitis, ciprofloxacin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous ciprofloxacin | Experimental | Drug: intravenous ciprofloxacin |
| intravenous ceftriaxone | Placebo comparator | Drug: intravenous ceftriaxone |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Hemorrhagic or malignant ascites. (on history).
- Tuberculous with secondary peritonitis (on medical record file).
- Hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous ciprofloxacinIn 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 | Drug | intravenous ciprofloxacin |
| intravenous ceftriaxonein 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 | Drug | intravenous ceftriaxone |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous ciprofloxacin and intravenous ceftriaxone in people with Cirrhosis, run by Shahida Islam Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of efficacy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.