Spontaneous Bacterial PeritonitisNCT03702426
Comparison of the Efficacy of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis
A study testing GMCSF and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- GMCSF and Norfloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 23 Jul 2018to 31 Jul 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70years
- Patients of decompensated liver cirrhosis who present with spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascitic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that has responded to standard medical care.
Who cannot join
- Allergic to quinolones
- Advanced HCC (Hepatocellular Carcinoma)
- Post liver transplant
- HIV (Human Immunodeficiency Virus) positive patients
- Patients on immunosuppressive therapy
- Pregnancy
Show all 9Show fewer
- Acute Liver Failure
- History of hematological malignancy or bone marrow transplantation
- No informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Comparison of the Efficacy of Granulocyte - Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis - A Randomised Controlled Trial
-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- GMCSF, Norfloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMCSFDrug
GMCSF 1.5mcg/Kg
NorfloxacinDrug
Tablet Norfloxacin 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Norfloxacin with GM-CSF | Experimental | Oral Norfloxacin 400mg daily and GM-CSF (Granulocyte-Macrophage colony-stimulating factor) in a dose of 1.5mcg/kg over 4 hour infusion every 15 days will be given in Group B Receives: Drug: GMCSF; Drug: Norfloxacin |
| Norfloxacin | Active comparator | Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A. Receives: Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid
Measured: 6 Month
Secondary outcomes (4)
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
Measured: 4 weeks
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
Measured: 12 weeks
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
Measured: 24 weeks
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start23 Jul 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702426
- Sponsor's protocol ID
- ILBS-SBP-01
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2018
- Last updated
- 24 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Granulocyte - Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03702426
- Acronym / sponsor ID
- ILBS-SBP-01
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Oct 2018 (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.
-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norfloxacin with GM-CSF | Experimental | Drug: GMCSF, Drug: NorfloxacinOral Norfloxacin 400mg daily and GM-CSF (Granulocyte-Macrophage colony-stimulating factor) in a dose of 1.5mcg/kg over 4 hour infusion every 15 days will be given in Group B |
| Norfloxacin | Active comparator | Drug: NorfloxacinPatients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 70years
- Patients of decompensated liver cirrhosis who present with spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascitic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that has responded to standard medical care.
Key exclusion criteria (9 listed)
- Allergic to quinolones
- Advanced HCC (Hepatocellular Carcinoma)
- Post liver transplant
- HIV (Human Immunodeficiency Virus) positive patients
- Patients on immunosuppressive therapy
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 |
|---|---|---|
| GMCSFGMCSF 1.5mcg/Kg | Drug | Norfloxacin with GM-CSF |
| NorfloxacinTablet Norfloxacin 400 mg | Drug | Norfloxacin, Norfloxacin with GM-CSF |
Primary outcome
Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups
Time frame: 6 Month
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid
4 secondary outcomes
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Time frame: 4 weeks
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Time frame: 12 weeks
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Time frame: 24 weeks
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
Time frame: 48 weeks
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 24 Oct 2019.
- Individual participant dataSharing planned: No
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Spontaneous Bacterial Peritonitis
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 GMCSF and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 9 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 24 Oct 2019. 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 India. 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. 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?
Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups (time frame: 6 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 24 Oct 2019.