PeritonitisNCT00511212
Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract
A study testing intravenous immunoglobulin in people with Peritonitis and Postoperative Complications, run by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group at 1 site in Japan.
Trial summary
The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peritonitis, Postoperative Complications
- What is being tested?
- intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2007to Jun 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.
- Patients with >=38 degrees C, >=15,000/mm3 or <=3,000/mm3 of WBC and >=10mg/dL of CRP
- Patients who have no abscess on the abdominal image
- Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
- Patients who are 20 years old or older
- Patients who have signed the agreement for participation in this study
Who cannot join
- Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
- Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
- Patients who were administered immunoglobulin within 1 month before entry
- Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
- Patients with IgA deficiency
- Patients with hereditary fructose intolerance
Show all 11Show fewer
- Patients with history of allergy or adverse effect for antibacterial agents
- Patients who have underlying or concomitant disease that may seriously affect the assessment of this study
- Patients who are or could be pregnant
- Patients who have noninfectious fever, fungal infection or viral illness
- Other patients who are judged to be inadequate to participate in this study by their physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract
The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.
- Conditions
- Peritonitis, Postoperative Complications
- Being tested
- intravenous immunoglobulin
- Keywords
- severe peritonitis, SSI, lower digestive tract surgery, Severe peritonitis after lower digestive tract surgery
- Medical subject headings
- Peritonitis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical efficacy
Measured: at day 7
Secondary outcomes (1)
clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms
Measured: at day 3 and at the end of test drug administration,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Study completionJun 2009 (estimated)
Why it stopped: No eligible patient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Sponsor type
- University, hospital or other
- Investigators
- Morito Monden, MD, PhD, Study chair, Multicenter Clinical Study Group of Osaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511212
- Sponsor's protocol ID
- MCSGO-0701
- Status last verified
- Aug 2007
- First submitted
- 1 Aug 2007
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract
- ClinicalTrials.gov ID
- NCT00511212
- Acronym / sponsor ID
- MCSGO-0701
- Conditions
- Peritonitis, Postoperative Complications
- Keywords
- severe peritonitis, SSI, lower digestive tract surgery, Severe peritonitis after lower digestive tract surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No eligible patient.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment GroupUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Jun 2009 (estimated)
- First posted
- 3 Aug 2007 (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.
The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.
- Patients with >=38 degrees C, >=15,000/mm3 or <=3,000/mm3 of WBC and >=10mg/dL of CRP
- Patients who have no abscess on the abdominal image
- Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
- Patients who are 20 years old or older
Key exclusion criteria (11 listed)
- Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
- Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
- Patients who were administered immunoglobulin within 1 month before entry
- Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
- Patients with IgA deficiency
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 |
|---|---|---|
| intravenous immunoglobulin | Drug | – |
Primary outcome
clinical efficacy
Time frame: at day 7
1 secondary outcome
clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms
Time frame: at day 3 and at the end of test drug administration,
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Morito Monden, MD, PhD study chair
Multicenter Clinical Study Group of Osaka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous immunoglobulin in people with Peritonitis and Postoperative Complications, run by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group at 1 site in Japan.
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 11 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: withdrawn, as of the sponsor's last update on 21 Jul 2011. 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 Japan. 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 was withdrawn before enrolling participants, so there are no results.
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?
clinical efficacy (time frame: at day 7). 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 21 Jul 2011.