Pancreatitis,Acute NecrotizingPhase 4NCT01992198
Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis
A Phase 4 study testing cefoperazone + metronidazole, oral care by chlorhexidine gluconate and enteral nutrition in people with Pancreatitis,Acute Necrotizing, run by Erzhen Chen at 1 site in China.
Trial summary
Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis,Acute Necrotizing
- What is being tested?
- cefoperazone + metronidazole, oral care by chlorhexidine gluconate and enteral nutrition
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe Acute Pancreatitis according to Atlanta criteria revisited in 2012
Who cannot join
- concurrent sepsis or (peri)pancreatic infection caused by a second disease
- patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease)
- recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis
- pregnancy, malignancy or immunodeficiency
- a history of allergy to meropenem, cefoperazone and metronidazole
- a history of antibiotic administration within 48 h prior to enrollment
- possible death within 48 h after enrollment
Trial locations and contacts
1 site in 1 country.
Erzhen Chen, M.D contact
Enqiang Mao, M.D contact
China1 site, 1 recruiting
- Recruiting
Depatrment of EICU,Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Erzhen Chen, M.D, 86-13901753478
Enqiang, Mao, 86-13501747906
About this study
Official title: Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis
Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.
Read the detailed description
SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.
In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.
In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial.
- Conditions
- Pancreatitis,Acute Necrotizing
- Being tested
- cefoperazone + metronidazole, oral care by chlorhexidine gluconate, enteral nutrition, Somatostatin, Meropenem
- Keywords
- antibiothearpy strategy, cefoperazone, metronidazole, meropenem
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefoperazone + metronidazoleDrug
Also called Cefobid, Metronidazole
1.Clinical parameters (2 of 3):
1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3):
1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h
oral care by chlorhexidine gluconateProcedure or surgery
Also called chlorhexidine gluconate
oral care by 0.2% chlorhexidine gluconate twice daily
enteral nutritionProcedure or surgery
Also called Enteral Nutritional Suspension(SP) by NUTRICIA
SomatostatinDrug
Also called somatostatin by merk
MeropenemDrug
All patients in cefo-group do not meet 1 of 3 laboratory parameter or image parameter or 2 of 3 clinical parameters.
1.Clinical parameters (2 of 3):
1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3):
1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h
| Study group | Role | What they receive |
|---|---|---|
| cefoperazone + metronidazole | Experimental | cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition Receives: Procedure: oral care by chlorhexidine gluconate; Procedure: enteral nutrition; Drug: Somatostatin; Drug: Meropenem |
| meropenem | Active comparator | Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition Receives: Drug: cefoperazone + metronidazole; Procedure: oral care by chlorhexidine gluconate; Procedure: enteral nutrition; Drug: Somatostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic or peripancreatic infection
Measured: 28-day
Secondary outcomes (2)
cost of management of SAP
Measured: 90-day
Microbiology resistance
sputum, urine and blood culture will be done once or twice per week if needed. bill or other culutre will be done when the patient is undergoing operation.
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis,Acute NecrotizingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzhen Chen
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Sponsor-investigator, Erzhen Chen, Ruijin Hospital
- Investigators
- Er-Zhen Chen, M.D. & Ph.D., Study chair, Ruijin HospitalEn-Qiang Mao, M.D. & Ph.D., Study director, Ruijin HospitalZhi-Tao Yang, M.D. & Ph.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992198
- Sponsor's protocol ID
- SAP BUNDLE-ANTIBIOTICS
- Other IDs
- 12411950500
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01992198
- Acronym / sponsor ID
- SAP BUNDLE-ANTIBIOTICS
- Conditions
- Pancreatitis,Acute Necrotizing
- Keywords
- antibiothearpy strategy, cefoperazone, metronidazole, meropenem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzhen ChenUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 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.
Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.
Detailed description
SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.
In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.
In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cefoperazone + metronidazole | Experimental | Procedure: oral care by chlorhexidine gluconate, Procedure: enteral nutrition, Drug: Somatostatin, Drug: Meropenemcefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition |
| meropenem | Active comparator | Drug: cefoperazone + metronidazole, Procedure: oral care by chlorhexidine gluconate, Procedure: enteral nutrition, Drug: SomatostatinMeropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe Acute Pancreatitis according to Atlanta criteria revisited in 2012
Key exclusion criteria (7 listed)
- concurrent sepsis or (peri)pancreatic infection caused by a second disease
- patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease)
- recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis
- pregnancy, malignancy or immunodeficiency
- a history of allergy to meropenem, cefoperazone and metronidazole
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 |
|---|---|---|
| cefoperazone + metronidazoleAlso: Cefobid, Metronidazole1.Clinical parameters (2 of 3): 1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3): 1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h | Drug | meropenem |
| oral care by chlorhexidine gluconateAlso: chlorhexidine gluconateoral care by 0.2% chlorhexidine gluconate twice daily | Procedure or surgery | cefoperazone + metronidazole, meropenem |
| enteral nutritionAlso: Enteral Nutritional Suspension(SP) by NUTRICIA | Procedure or surgery | cefoperazone + metronidazole, meropenem |
| SomatostatinAlso: somatostatin by merk | Drug | cefoperazone + metronidazole, meropenem |
| MeropenemAll patients in cefo-group do not meet 1 of 3 laboratory parameter or image parameter or 2 of 3 clinical parameters. 1.Clinical parameters (2 of 3): 1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3): 1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h | Drug | cefoperazone + metronidazole |
Primary outcome
pancreatic or peripancreatic infection
Time frame: 28-day
2 secondary outcomes
cost of management of SAP
Time frame: 90-day
Microbiology resistance
Time frame: 90-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
Erzhen Chen, M.D contact
Enqiang Mao, M.D contact
Er-Zhen Chen, M.D. & Ph.D. study chair
Ruijin Hospital
En-Qiang Mao, M.D. & Ph.D. study director
Ruijin Hospital
Zhi-Tao Yang, M.D. & Ph.D. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefoperazone + metronidazole, oral care by chlorhexidine gluconate and enteral nutrition in people with Pancreatitis,Acute Necrotizing, run by Erzhen Chen at 1 site in China.
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 1 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 25 Nov 2013. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Erzhen Chen, M.D (86-13901753478), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic or peripancreatic infection (time frame: 28-day). 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 25 Nov 2013.