Treatment Trial of Alveolar Echinococcosis

NCT07182305 | Completed Phase 2

• 1 other identifier: AE-Kyrgyzstan
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Echinococcosis

Keywords

alveolar echinococcosis; Echinococcus multilocularis; albendazole

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Cases defined as early stage alveolar echinococcosis receive daily dose of albendazole 2 x 400 mg

Drug: Efficacy of albendazole for early stage intervention of alveolar echinococcosis

Control

NO INTERVENTION

Cases defined as early stage alveolar echinococcosis not receiving placebo treatment

Interventions

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.

Treatment

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of lesion diagnosed by ultrasound that is consistent with early stage alveolar echinococcosis. Lesion less than 3 cm in diameter

You may not qualify if:

• Absence of lesion. Large lesion requiring surgical treatment

Sponsors & Collaborators

• Ministry of Health, Kyrgyzstan: lead
• University of Zurich: collaborator

Study Sites (1)

Department of disease prevention and sanitary - epidemiological surveillance

Bishkek, Kyrgyzstan

Location

MeSH Terms

Conditions

Alveolar echinococcosis; Echinococcosis

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections

Study Officials

• Gulnara Minbaeva, MD

  Department of disease prevention and sanitary - epidemiological surveillance, Ministry of Health of the Kyrgyz Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: September 19, 2025
• Study Start: May 1, 2017
• Primary Completion: April 30, 2021
• Study Completion: July 31, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)