Skip to main content
OpenTrials
Completed

NCT Number: NCT02941068

the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intra-abdominal Perforation Bacterial Infections and Mycoses Infections Inflammation Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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. -

Treatment and study plan

fluconazole and caspofungin

Drug

Primary outcomes

  1. all cause mortality

    Time frame: six months

Secondary outcomes

  1. fungal infection

    Time frame: six months

    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.

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Official study title

Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU

Important dates

Study start
2012
Primary completion
2016
First posted
Oct 21, 2016
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.