Appendicitis Clinical Trial
Official title:
A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Status | Completed |
Enrollment | 473 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours. - Fever plus other symptoms such as nausea, vomiting, abdominal pain. Exclusion Criteria: - Cancer - Medicines that suppress the immune system - Dialysis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Australia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit | CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug. | up to 6 weeks | No |
Secondary | Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit | ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. | up to 6 weeks | No |
Secondary | Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit | Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure. | up to 6 weeks | No |
Secondary | Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure | Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization | up to 6 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04529980 -
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
|
N/A | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Recruiting |
NCT03522233 -
Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
|
||
Recruiting |
NCT03380793 -
A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis
|
Phase 4 | |
Recruiting |
NCT02108340 -
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis
|
N/A | |
Terminated |
NCT02029781 -
The Laparoscopic Appendicitis Score; a Multicenter Validation Study
|
N/A | |
Completed |
NCT01356641 -
Antibiotic Treatment Alone for Acute Simple Appendicitis in Children
|
N/A | |
Completed |
NCT01515293 -
Single Incision Versus Conventional Laparoscopic Appendectomy
|
Phase 3 | |
Terminated |
NCT00971438 -
Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging
|
N/A | |
Completed |
NCT00913380 -
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
|
Phase 3 | |
Completed |
NCT00616616 -
Single Incision Laparoscopy
|
N/A | |
Completed |
NCT00530998 -
Minimally Invasive Surgery: Using Natural Orfices
|
||
Completed |
NCT00195351 -
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
|
Phase 4 | |
Completed |
NCT02916134 -
Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
|
N/A | |
Completed |
NCT04614649 -
Right Iliac Fossa Treatment-Turkey Audit
|
||
Completed |
NCT04365491 -
European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
|
||
Completed |
NCT03770897 -
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
|
N/A | |
Completed |
NCT02507674 -
Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
|
||
Active, not recruiting |
NCT01718275 -
Non-operative Management of Early Appendicitis in Children
|
||
Terminated |
NCT01575028 -
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
|
Phase 2 |