Spontaneous Bacterial PeritonitisNCT02468089
To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
A study testing Carbepenem, Albumin and GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups. Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Carbepenem, Albumin and GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2015to 31 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years
- Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:
- Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
- Recurrent SBP - One or more prior episode(s) of SBP in year.
- Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
- Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.
Who cannot join
- < 18 years.
- Advanced HCC (HepatoCellular Carcinoma)
- Post liver transplant
- HIV + ve, Immunosuppressive therapy
- Pregnancy
- Domiciliary treatment
- No consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.
Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Carbepenem, Albumin, GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbepenemDrug
AlbuminDrug
GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .Drug
| Study group | Role | What they receive |
|---|---|---|
| Carbepenem+albumin+GMCSF. | Experimental | Not described Receives: Drug: Carbepenem; Drug: Albumin; Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . |
| Carbepenem+albumin | Active comparator | Not described Receives: Drug: Carbepenem; Drug: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
Measured: 1 week
Secondary outcomes (7)
Survival at week 2
Measured: week 2
Survival at week 4
Measured: week 4
Survival at week 12
Measured: week 12
Total number of patients develop variceal bleed.
Measured: 1 week
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.
Measured: 1 week
Total number of patients develop HE (Hepatic Encephalopathy).
Measured: 1 week
Total number of patients develop AKI (Acute kidney Injury).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start1 May 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikash Prakash, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468089
- Sponsor's protocol ID
- ILBS-SBP-001
- Status last verified
- Jan 2017
- First submitted
- 22 May 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT02468089
- Acronym / sponsor ID
- ILBS-SBP-001
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- 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.
A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.
Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbepenem+albumin+GMCSF. | Experimental | Drug: Carbepenem, Drug: Albumin, Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . |
| Carbepenem+albumin | Active comparator | Drug: Carbepenem, Drug: Albumin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age more than 18 years
- Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:
Key exclusion criteria (7 listed)
- < 18 years.
- Advanced HCC (HepatoCellular Carcinoma)
- Post liver transplant
- HIV + ve, Immunosuppressive therapy
- Pregnancy
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 |
|---|---|---|
| Carbepenem | Drug | Carbepenem+albumin, Carbepenem+albumin+GMCSF. |
| Albumin | Drug | Carbepenem+albumin, Carbepenem+albumin+GMCSF. |
| GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . | Drug | Carbepenem+albumin+GMCSF. |
Primary outcome
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
Time frame: 1 week
7 secondary outcomes
Survival at week 2
Time frame: week 2
Survival at week 4
Time frame: week 4
Survival at week 12
Time frame: week 12
Total number of patients develop variceal bleed.
Time frame: 1 week
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.
Time frame: 1 week
Total number of patients develop HE (Hepatic Encephalopathy).
Time frame: 1 week
Total number of patients develop AKI (Acute kidney Injury).
Time frame: 1 week
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 6 Nov 2017.
Related trials for Spontaneous Bacterial Peritonitis
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SBP - Spontaneous Bacterial Peritonitis
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N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
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Not yet recruitingPhase 4
Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
Cirrhosis With Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
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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.
Vikash Prakash, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbepenem, Albumin and GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . 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 6 inclusion and 7 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 6 Nov 2017. 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?
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis) (time frame: 1 week). 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 6 Nov 2017.