Treatment Trial of Alveolar Echinococcosis

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.

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Key information

Conditions

Alveolar Echinococcosis Cestode Infections Echinococcosis Helminthiasis Infections Parasitic Diseases

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of disease prevention and sanitary - epidemiological surveillance

Bishkek, Kyrgyzstan

About this study

case definition of patients with early stage alveolar echinococcosis. These are patients who are otherwise healthy, but have been identified as having hepatic lesions consistent with alveolar echinococcosis as diagnosed by ultrasound through a monitoring programme.
Subjects will be randomised 60 patients into treatment and 60 into non treatment groups.
Randomisation should be such that approximately similar age and gender profiles match in each group.
Baseline examination by imaging. Define the lesion and case definition. Blood samples taken from all subjects at baseline
Blood is analysed for serological evidence of echinococcosis
Treatment is started. Treatment for case group is 2 x 400 mg Albendazole, daily. Control group has a placebo.
Monitor at 2 weeks and 4 weeks for liver function, serology and imaging
Monitor every 3 months thereafter.
Subjects that have any evidence of lesion progression will be referred for surgical treatment regardless of treatment group.
Monitoring for 2 years. Assess lesions in treatment and placebo groups. Assess dynamics of antibody (if any). Assess numbers of subjects from each group who have been referred for surgery following progression of lesion.
Indicators for premature ending of trail would include evidence that the treatment is effective (ie treatment group not progressing or lesions regressing, whilst non treatment group lesions increase in size) - action all subjects now put into therapy.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Absence of lesion. Large lesion requiring surgical treatment

Treatment and study plan

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.

Primary outcomes

Progression of parasitic lesion

Time frame: 3 years

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.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Kyrgyzstan

Other Gov

Collaborators

University of Zurich

Registry information

Official study title

Treatment Trial With Albendazole of Patients With a Diagnosis of Early Stage Alveolar Echinococcosis

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2023
First posted: Sep 19, 2025
Registry last updated: Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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