Spontaneous Bacterial PeritonitisNCT04208763
A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.
A study testing Imipenem, Tigecycline and GMCSF in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study population: A total of 90 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences with SBP with septic shock will be included. Study design: Randomized controlled trial Study period: August 2019 to December 2021. 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?
- Imipenem, Tigecycline and GMCSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 20 Dec 2019to 31 Dec 2021
- 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
- Spontaneous Bacterial Peritonitis (SBP) with shock in a cirrhotic
- Hospital acquired SBP with shock
- Difficult to treat SBP
Who cannot join
- Refractory Shock
- Cardiac comorbidities (known Coronary Artery Disease)
- Chronic Kidney Disease on Maintenance Hemodialysis
- < 18 years.
- Advanced Hepatocellular Carcinoma
- Post liver transplant
- HIV + ve, Immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Abhijeet Ranjan, MD, 01146300000, drkmrabhijeet@gmail.com
About this study
Official title: Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.
Study population: A total of 90 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences with SBP with septic shock will be included.
Study design: Randomized controlled trial Study period: August 2019 to December 2021. Sample size: Assuming that the response rate is 90% with GM-CSF and 60% without GM-CSF after day 5. With alpha 5 and power 80,we need to enroll 76 cases (38 cases with each). Further assuming 20 % drop-out due to various reasons, it was decided to enroll 90 cases randomly allocated into two groups (i.e., 45 in each) by block randomization method by taking block size as 6. So for the present study, it was decided to enroll 90 cases in all.
Read more
Group A will be given Imipenem and Tigecycline. Patients with recent hospitalisation will be given Colistin in addition.
Group B will be given: To another group we will give Imipenem and Tigecycline and GMCSF.Patients with recent hospitalisation will be given Colistin in addition.
The dose of antibiotic will be given at dosage Inj Imipenem 1gm i.v. TDS Inj Tigecycline 100mg stat f/b 50mg i.v. OD Inj GM-CSF 500mcg s.c. OD Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD Monitoring and assessment At the baseline, all patients will undergo investigational evaluation as described
Daily monitoring of following parameters:
- Haemoglobin,
- Total peripheral leucocyte counts,
- Platelet counts,
- Renal function tests
- Liver function tests and
- Chest X rays will be undertaken
- Ascitic fluid analysis will be done on day 0, day 2 and day 5
Stopping rule:If the patient develops a TLC of more than 50,000, the dose of the GM CSF will be reduced to half and the treatment continued. If, even after the reduction, the TLC rises to more than 50,000, then the treatment will be stopped and the patient excluded.
Expected outcome of the project: Addition of GM-CSF to standard antibiotic regimen helps resolve SBP and improves outcome in decompensated liver cirrhotic patients.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Imipenem, Tigecycline, GMCSF, Colistin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipenemDrug
Inj Imipenem 1gm i.v. TDS
TigecyclineDrug
Inj Tigecycline 100mg stat f/b 50mg i.v. OD
GMCSFDrug
Inj GM-CSF 500mcg s.c. OD
ColistinDrug
Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD
| Study group | Role | What they receive |
|---|---|---|
| Imipenem+Tigecycline+GM-CSF | Experimental | Not described Receives: Drug: Imipenem; Drug: Tigecycline; Drug: GMCSF; Drug: Colistin |
| Imipenem+Tigecycline | Active comparator | Not described Receives: Drug: Imipenem; Drug: Tigecycline; Drug: Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Spontaneous Bacterial peritonitis in both groups
Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250
Measured: Day 5
Secondary outcomes (11)
Reversal of shock in both groups
Blood pressure more than 90/60 mmHg with no inotropes requirement
Measured: Day 2
Survival in both groups
Measured: Day 7
Survival in both groups
Measured: Day 28
Change in ascitic fluid metabolites Nitric Oxide in both groups
change is defined as percentage reduction in nitric oxide
Measured: Day 28
Change in ascitic fluid macrophage population in both groups
change is defined as percentage reduction in macrophage population
Measured: Day 28
Development of Hepatic Encephalopathy in both groups.
Hepatic Encephalopathy will be measured as per West Haven criteria
Measured: Day 28
Development of Acute Kidney Injury in both groups
AKIN criteria will be used for Acute kidney injury
Measured: Day 28
Development of Pneumonia in both groups.
Pneumonia will be confirmed based on imaging and clinically
Measured: Day 28
Development of organ failures in both groups.
Organ failure will be as per APACHE score
Measured: Day 28
Development of coagulopathy in both groups.
Coagulopathy is defined as INR > 1.5
Measured: Day 28
Resolution of Spontaneous Bacterial peritonitis in both groups
Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start20 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- 90 participants (estimated)
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
- NCT04208763
- Sponsor's protocol ID
- ILBS-SBP-02
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.
- ClinicalTrials.gov ID
- NCT04208763
- Acronym / sponsor ID
- ILBS-SBP-02
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Dec 2019 (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.
Study population: A total of 90 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences with SBP with septic shock will be included.
Study design: Randomized controlled trial Study period: August 2019 to December 2021. Sample size: Assuming that the response rate is 90% with GM-CSF and 60% without GM-CSF after day 5. With alpha 5 and power 80,we need to enroll 76 cases (38 cases with each). Further assuming 20 % drop-out due to various reasons, it was decided to enroll 90 cases randomly allocated into two groups (i.e., 45 in each) by block randomization method by taking block size as 6. So for the present study, it was decided to enroll 90 cases in all.
Group A will be given Imipenem and Tigecycline. Patients with recent hospitalisation will be given Colistin in addition.
Group B will be given: To another group we will give Imipenem and Tigecycline and GMCSF.Patients with recent hospitalisation will be given Colistin in addition.
The dose of antibiotic will be given at dosage Inj Imipenem 1gm i.v. TDS Inj Tigecycline 100mg stat f/b 50mg i.v. OD Inj GM-CSF 500mcg s.c. OD Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD Monitoring and assessment At the baseline, all patients will undergo investigational evaluation as described
Daily monitoring of following parameters:
- Haemoglobin,
- Total peripheral leucocyte counts,
- Platelet counts,
- Renal function tests
- Liver function tests and
- Chest X rays will be undertaken
- Ascitic fluid analysis will be done on day 0, day 2 and day 5
Stopping rule:If the patient develops a TLC of more than 50,000, the dose of the GM CSF will be reduced to half and the treatment continued. If, even after the reduction, the TLC rises to more than 50,000, then the treatment will be stopped and the patient excluded.
Expected outcome of the project: Addition of GM-CSF to standard antibiotic regimen helps resolve SBP and improves outcome in decompensated liver cirrhotic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imipenem+Tigecycline+GM-CSF | Experimental | Drug: Imipenem, Drug: Tigecycline, Drug: GMCSF, Drug: Colistin |
| Imipenem+Tigecycline | Active comparator | Drug: Imipenem, Drug: Tigecycline, Drug: Colistin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spontaneous Bacterial Peritonitis (SBP) with shock in a cirrhotic
- Hospital acquired SBP with shock
- Difficult to treat SBP
Key exclusion criteria (7 listed)
- Refractory Shock
- Cardiac comorbidities (known Coronary Artery Disease)
- Chronic Kidney Disease on Maintenance Hemodialysis
- < 18 years.
- Advanced 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 |
|---|---|---|
| ImipenemInj Imipenem 1gm i.v. TDS | Drug | Imipenem+Tigecycline, Imipenem+Tigecycline+GM-CSF |
| TigecyclineInj Tigecycline 100mg stat f/b 50mg i.v. OD | Drug | Imipenem+Tigecycline, Imipenem+Tigecycline+GM-CSF |
| GMCSFInj GM-CSF 500mcg s.c. OD | Drug | Imipenem+Tigecycline+GM-CSF |
| ColistinInj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD | Drug | Imipenem+Tigecycline, Imipenem+Tigecycline+GM-CSF |
Primary outcome
Resolution of Spontaneous Bacterial peritonitis in both groups
Time frame: Day 5
Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250
11 secondary outcomes
Reversal of shock in both groups
Time frame: Day 2
Survival in both groups
Time frame: Day 7
Survival in both groups
Time frame: Day 28
Change in ascitic fluid metabolites Nitric Oxide in both groups
Time frame: Day 28
Change in ascitic fluid macrophage population in both groups
Time frame: Day 28
Development of Hepatic Encephalopathy in both groups.
Time frame: Day 28
Development of Acute Kidney Injury in both groups
Time frame: Day 28
Development of Pneumonia in both groups.
Time frame: Day 28
Development of organ failures in both groups.
Time frame: Day 28
Development of coagulopathy in both groups.
Time frame: Day 28
Resolution of Spontaneous Bacterial peritonitis in both groups
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imipenem, Tigecycline and GMCSF 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 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Abhijeet Ranjan, MD (01146300000, drkmrabhijeet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Spontaneous Bacterial peritonitis in both groups (time frame: Day 5). 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 16 Feb 2021.