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

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
Change History	Complete list of historical versions of study NCT00658294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Removed Location Countries
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