Alveolar EchinococcosisNCT00658294
Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles
An observational study of Alveolar Echinococcosis, run by University of Zurich at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Echinococcosis
- What is being tested?
- Stop treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to 31 Dec 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inoperable alveolar echinococchosis
Who may be able to join
- Patients with inoperable alveolar echinococcosis
- With negative PET-CT
- EmII/3-10 serology under long-term chemotherapy with benzimidazoles
Who cannot join
- Positive PET-CT
- Positive EmII-3-10 Serology
- No compliance
- Reduced life expectancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Alveolar Echinococcosis
- Being tested
- Stop treatment
- Medical subject headings
- Alveolar echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop treatmentOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJan 2008
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar EchinococcosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beat Müllhaupt 01 Studienregister MasterAdmins, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658294
- Sponsor's protocol ID
- EK-1351
- Status last verified
- Oct 2017
- First submitted
- 8 Apr 2008
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ammann RW, Stumpe KD, Grimm F, Deplazes P, Huber S, Bertogg K, Fischer DR, Mullhaupt 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.
PubMed 26389799
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00658294
- Acronym / sponsor ID
- EK-1351
- Conditions
- Alveolar Echinococcosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 14 Apr 2008 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inoperable alveolar echinococchosis
Key inclusion criteria (3 listed)
- Patients with inoperable alveolar echinococcosis
- With negative PET-CT
- EmII/3-10 serology under long-term chemotherapy with benzimidazoles
Key exclusion criteria (5 listed)
- Positive PET-CT
- Positive EmII-3-10 Serology
- No compliance
- Reduced life expectancy
- Pregnancy
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 |
|---|---|---|
| Stop treatment | Other | – |
Primary outcome
Not reported in the source record.
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 17 Oct 2017.
- Results publication: PubMed 26389799Ammann RW, Stumpe KD, Grimm F, Deplazes P, Huber S, Bertogg K, Fischer DR, Mullhaupt 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.
- Individual participant dataSharing planned: No
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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.
Beat Müllhaupt 01 Studienregister MasterAdmins principal investigator
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Echinococcosis, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 5 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 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658294, which also lists 1 linked publication.
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 17 Oct 2017.