Intra-abdominal PerforationPhase 2NCT02941068
the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations
A Phase 2 study testing fluconazole and caspofungin in people with Intra-abdominal Perforation, run by Nanjing PLA General Hospital.
Trial summary
This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Intra-abdominal Perforation
- What is being tested?
- fluconazole and caspofungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jun 2016
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age ≥16 years
- the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours
- ICU stay of at least 5 days
- APACHE Ⅱ score within 24 hours of randomization of 16 or more
- severe sepsis
- written informed consent -
Who cannot join
- documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study;
- fluconazole/caspofungin allergy;
- pregnant of lactating woman;
- life expectancy of 48 hours or less. -
About this study
Official title: Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU
This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group.
Read the detailed description
Intra-abdominal perforation is the high risk of fungal infection. The flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in ICU develop intra-abdominal fungal infection. In particular, the severe sepsis arisen from these infections could further increase the mortality. However, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with GI Perforation.
- Conditions
- Intra-abdominal Perforation
- Being tested
- fluconazole and caspofungin
- Keywords
- severe sepsis, intra-abdominal perforation, surgical intensive care unit, fungal infection, prophylactic anti-fungal treatment
- Medical subject headings
- Sepsis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluconazole and caspofunginDrug
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic group | Experimental | Patients would received intravenous fluconazole (loading dose 800 mg, then 400 mg/day) or caspofungin (loading dose 70 mg, then 50 mg/day) if patients had organ failure or renal or liver dysfunction during the immediately surgery. The antifungal treatment would continue for 5 to 7 days. Receives: Drug: fluconazole and caspofungin |
| Empirical group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: six months
Secondary outcomes (1)
fungal infection
An blood specimen and abdominal drainage fluids if available were obtained for microbiological culture at the time of the gastrointestinal perforations and intra-abdominal specimen was collected at the time of the immediately surgery. All specimens were also obtained 1st, 3rd, 5th, 7th day after perforations and thereafter at 3 days intervals.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startMar 2012
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intra-abdominal PerforationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Tao, Nanjing PLA General Hospital
- Investigators
- gao tao, ph.d, Principal investigator, Nanjing PLA General Hospitalcao chun, ph.d, Study director, Nanjing PLA General Hospitalshi jialiang, ph.d, Principal investigator, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941068
- Sponsor's protocol ID
- 2012NLY032
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Montravers P, Dupont H, Gauzit R, Veber B, Auboyer C, Blin P, Hennequin C, Martin C. Candida as a risk factor for mortality in peritonitis. Crit Care Med. 2006 Mar;34(3):646-52. doi: 10.1097/01.CCM.0000201889.39443.D2.
PubMed 16505648Senn L, Eggimann P, Ksontini R, Pascual A, Demartines N, Bille J, Calandra T, Marchetti O. Caspofungin for prevention of intra-abdominal candidiasis in high-risk surgical patients. Intensive Care Med. 2009 May;35(5):903-8. doi: 10.1007/s00134-009-1405-8. Epub 2009 Jan 27.
PubMed 19172247
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU
- ClinicalTrials.gov ID
- NCT02941068
- Acronym / sponsor ID
- 2012NLY032
- Conditions
- Intra-abdominal Perforation
- Keywords
- severe sepsis, intra-abdominal perforation, surgical intensive care unit, fungal infection, prophylactic anti-fungal treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2016 (actual)
- First posted
- 21 Oct 2016 (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.
This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group.
Detailed description
Intra-abdominal perforation is the high risk of fungal infection. The flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in ICU develop intra-abdominal fungal infection. In particular, the severe sepsis arisen from these infections could further increase the mortality. However, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with GI Perforation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic group | Experimental | Drug: fluconazole and caspofunginPatients would received intravenous fluconazole (loading dose 800 mg, then 400 mg/day) or caspofungin (loading dose 70 mg, then 50 mg/day) if patients had organ failure or renal or liver dysfunction during the immediately surgery. The antifungal treatment would continue for 5 to 7 days. |
| Empirical group | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥16 years
- the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours
- ICU stay of at least 5 days
- APACHE Ⅱ score within 24 hours of randomization of 16 or more
- severe sepsis
Key exclusion criteria (4 listed)
- documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study;
- fluconazole/caspofungin allergy;
- pregnant of lactating woman;
- life expectancy of 48 hours or less. -
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 |
|---|---|---|
| fluconazole and caspofungin | Drug | Prophylactic group |
Primary outcome
all cause mortality
Time frame: six months
1 secondary outcome
fungal infection
Time frame: six 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 21 Oct 2016.
- Results publication: PubMed 16505648Montravers P, Dupont H, Gauzit R, Veber B, Auboyer C, Blin P, Hennequin C, Martin C. Candida as a risk factor for mortality in peritonitis. Crit Care Med. 2006 Mar;34(3):646-52. doi: 10.1097/01.CCM.0000201889.39443.D2.
- Results publication: PubMed 19172247Senn L, Eggimann P, Ksontini R, Pascual A, Demartines N, Bille J, Calandra T, Marchetti O. Caspofungin for prevention of intra-abdominal candidiasis in high-risk surgical patients. Intensive Care Med. 2009 May;35(5):903-8. doi: 10.1007/s00134-009-1405-8. Epub 2009 Jan 27.
- Individual participant dataSharing planned: Undecided
Related trials for Intra-abdominal Perforation
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 4
APPI-Cost Trial for Perforated Appendicitis
Perforated Appendicitis
Not yet recruitingPhase 4
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study
Acute, Perforated Appendicitis
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.
gao tao, ph.d principal investigator
Nanjing PLA General Hospital
cao chun, ph.d study director
Nanjing PLA General Hospital
shi jialiang, ph.d principal investigator
Nanjing PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluconazole and caspofungin in people with Intra-abdominal Perforation, run by Nanjing PLA General Hospital.
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 4 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
all cause mortality (time frame: six months). 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 NCT02941068, which also lists 2 linked publications.
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 Oct 2016.