Spontaneous Bacterial PeritonitisNCT01852630
Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
A study testing cefepime + Albumin and Imipenem + Albumin in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver \& Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- cefepime + Albumin and Imipenem + Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Dec 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic Patients with SBP (Spontaneous Bacterial Peritonitis) having any of the following risk factors would be considered as 'Difficult to Treat SBP' and would be included -
- Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or
- Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or
- No response to treatment with 3rd generation cephalosporins after 48 hours.
Who cannot join
- Age less than 18 years.
- Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
- Post liver transplant, HIV patients.
- Patients on systemic chemotherapy, immunosuppressant drugs.
- Growth of bacteria resistant to intervention drugs in ascitic fluid culture.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.
- All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver \& Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission.
- SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem.
- However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).
Read the detailed description
Baseline evaluation:
Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.
- Etiology of cirrhosis.
- Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score
- Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
- Laboratory investigations:
Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein, sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as available.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- cefepime + Albumin, Imipenem + Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefepime + AlbuminDrug
cefepime + Albumin will be given for 2 days
Imipenem + AlbuminDrug
Imipenem + Albumin will be given for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| cefepime + Albumin | Experimental | cefepime 1g iv 8 hourly + Albumin will be given for 2 days. Receives: Drug: Imipenem + Albumin |
| Imipenem + Albumin | Active comparator | Imipenem 1g iv 8 hourly + Albumin will be given for 2 days. Receives: Drug: cefepime + Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is the Response to treatment in each intervention group. Response is defined as 25% reduction in ANC (Absolute Neutrophil Count) from baseline.
Measured: 2 days
Secondary outcomes (1)
Survival
Measured: 15 days,1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Ankur Jindal, MD, Principal investigator, Institute of Liver & Biliary Sciences (ILBS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852630
- Sponsor's protocol ID
- ILBS- SBP-01
- Status last verified
- Jul 2016
- First submitted
- 6 Dec 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jindal A, Kumar M, Bhadoria AS, Maiwall R, Sarin SK. A randomized open label study of 'imipenem vs. cefepime' in spontaneous bacterial peritonitis. Liver Int. 2016 May;36(5):677-87. doi: 10.1111/liv.12985. Epub 2015 Nov 21.
PubMed 26474358
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.
- ClinicalTrials.gov ID
- NCT01852630
- Acronym / sponsor ID
- ILBS- SBP-01
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 May 2013 (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.
- All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver \& Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission.
- SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem.
- However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).
Detailed description
Baseline evaluation:
Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.
- Etiology of cirrhosis.
- Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score
- Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
- Laboratory investigations:
Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein, sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cefepime + Albumin | Experimental | Drug: Imipenem + Albumincefepime 1g iv 8 hourly + Albumin will be given for 2 days. |
| Imipenem + Albumin | Active comparator | Drug: cefepime + AlbuminImipenem 1g iv 8 hourly + Albumin will be given for 2 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhotic Patients with SBP (Spontaneous Bacterial Peritonitis) having any of the following risk factors would be considered as 'Difficult to Treat SBP' and would be included -
- Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or
- Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or
- No response to treatment with 3rd generation cephalosporins after 48 hours.
Key exclusion criteria (5 listed)
- Age less than 18 years.
- Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
- Post liver transplant, HIV patients.
- Patients on systemic chemotherapy, immunosuppressant drugs.
- Growth of bacteria resistant to intervention drugs in ascitic fluid culture.
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 |
|---|---|---|
| cefepime + Albumincefepime + Albumin will be given for 2 days | Drug | Imipenem + Albumin |
| Imipenem + AlbuminImipenem + Albumin will be given for 2 days. | Drug | cefepime + Albumin |
Primary outcome
The primary outcome of the study is the Response to treatment in each intervention group. Response is defined as 25% reduction in ANC (Absolute Neutrophil Count) from baseline.
Time frame: 2 days
1 secondary outcome
Survival
Time frame: 15 days,1 month and 3 months
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 22 Nov 2016.
- Derived from this study: PubMed 26474358Jindal A, Kumar M, Bhadoria AS, Maiwall R, Sarin SK. A randomized open label study of 'imipenem vs. cefepime' in spontaneous bacterial peritonitis. Liver Int. 2016 May;36(5):677-87. doi: 10.1111/liv.12985. Epub 2015 Nov 21.
Related trials for Spontaneous Bacterial Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
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
Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
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.
Dr Ankur Jindal, MD principal investigator
Institute of Liver & Biliary Sciences (ILBS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cefepime + Albumin and Imipenem + Albumin 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 4 inclusion and 5 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 22 Nov 2016. 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?
The primary outcome of the study is the Response to treatment in each intervention group. Response is defined as 25% reduction in ANC (Absolute Neutrophil Count) from baseline. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852630, which also lists 1 linked publication.
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 22 Nov 2016.