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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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A new focus of subjects with lesions of alveolar echinococcosis caused by Echinococcus multilocularis has been found south of Gulcha in Osh province in Kyrgyzstan by an ultrasound surveillance. Prevalence of infections is approximately 6%. Most lesions are small. Current scientific evidence suggests that in the absence of treatment, alveolar echinococcosis has a case fatality rate approaching 100% within 10-15 years of infection. Albendazole is known to be effective as a parasitostatic treatment to prolong the life of subjects with this disease, possibly up to normal life expectancy with prolonged treatment. The trial will be a case control study to evaluate the treatment of subjects with early stage alveolar echinococcosis and the progression of disease.
No effect of albendazole - lesions progressing in all cases - indicating surgical treatment required in all cases.
Most lesions regressing in both the treatment and control group - indicates most early cases spontaneously resolve. Stop treatment but continue to monitor all cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Cases defined as early stage alveolar echinococcosis receive daily dose of albendazole 2 x 400 mg |
|
| Control | No Intervention | Cases defined as early stage alveolar echinococcosis not receiving placebo treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efficacy of albendazole for early stage intervention of alveolar echinococcosis | Drug | Participants in the treatment arm will be treated with albendazole, 2 x 400 mg daily for the duration of the study. Treatment may be prolonged beyond the end of the study if clinically appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of parasitic lesion | Increase in size of lesion or regression or calcification. Participants will be regularly assessed using ultrasound imaging of the lesion. The lesion size will me measured. The size of the lesion was measured using the cross-sectional image with the longest diameter on ultrasound. The measurement will be in millimeters. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gulnara Minbaeva, MD | Department of disease prevention and sanitary - epidemiological surveillance, Ministry of Health of the Kyrgyz Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of disease prevention and sanitary - epidemiological surveillance | Bishkek | Kyrgyzstan |
IPD will be confidential or anonymised. Results will be published but no patient will be identifiable. Such will be freely available from mid 2019 and available between the trial investigators from the start of the trial
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| ID | Term |
|---|---|
| C536591 | Alveolar echinococcosis |
| D004443 | Echinococcosis |
| ID | Term |
|---|---|
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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