Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles

• ClinicalTrials.gov Identifier: NCT00658294
• Recruitment Status: Completed
• First Posted: April 14, 2008
• Last Update Posted: October 17, 2017
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Tracking Information

• First Submitted Date: April 8, 2008
• First Posted Date: April 14, 2008
• Last Update Posted Date: October 17, 2017
• Actual Study Start Date: January 2008
• Actual Primary Completion Date: December 31, 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles
• Official Title: Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles in Patients With Inoperable Alveolar Echinococcosis Using PET-CT and EmII/3-10 Serology

Brief Summary

The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to assess the parasitocidal effect of benzimidazoles

• Trial with medicinal product

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with inoperable alveolar echinococchosis
• Condition: Alveolar Echinococcosis
• Intervention: Other: Stop treatment
• Study Groups/Cohorts: Not Provided
• Publications *: Ammann RW, Stumpe KD, Grimm F, Deplazes P, Huber S, Bertogg K, Fischer DR, Müllhaupt B. Outcome after Discontinuing Long-Term Benzimidazole Treatment in 11 Patients with Non-resectable Alveolar Echinococcosis with Negative FDG-PET/CT and Anti-EmII/3-10 Serology. PLoS Negl Trop Dis. 2015 Sep 21;9(9):e0003964. doi: 10.1371/journal.pntd.0003964. eCollection 2015.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2017): 34
• Original Estimated Enrollment (submitted: April 11, 2008): 30
• Actual Study Completion Date: December 31, 2012
• Actual Primary Completion Date: December 31, 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• Patients with inoperable alveolar echinococcosis
• With negative PET-CT
• EmII/3-10 serology under long-term chemotherapy with benzimidazoles

Exclusion criteria:

• Positive PET-CT
• Positive EmII-3-10 Serology
• No compliance
• Reduced life expectancy
• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00658294
• Other Study ID Numbers: EK-1351
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Zurich
• Study Sponsor: University of Zurich
• Collaborators: Not Provided

Investigators

• Principal Investigator: Beat Müllhaupt 01 Studienregister MasterAdmins; UniversitaetsSpital Zuerich

• PRS Account: University of Zurich
• Verification Date: October 2017