Treatment Trial of Alveolar Echinococcosis

Ministry of Health, Kyrgyzstan

Status and phase: Completed; Phase 2

Conditions: Alveolar Echinococcosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07182305

AE-Kyrgyzstan

Details and patient eligibility

About

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.

Full description

1. 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.
2. Subjects will be randomised 60 patients into treatment and 60 into non treatment groups.
3. Randomisation should be such that approximately similar age and gender profiles match in each group.
4. Baseline examination by imaging. Define the lesion and case definition. Blood samples taken from all subjects at baseline
5. Blood is analysed for serological evidence of echinococcosis
6. Treatment is started. Treatment for case group is 2 x 400 mg Albendazole, daily. Control group has a placebo.
7. Monitor at 2 weeks and 4 weeks for liver function, serology and imaging
8. Monitor every 3 months thereafter.
9. Subjects that have any evidence of lesion progression will be referred for surgical treatment regardless of treatment group.
10. 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.
11. 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.

Enrollment: 194 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

Treatment

Active Comparator group

Description:

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

Treatment:

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

Control

No Intervention group

Description:

Cases defined as early stage alveolar echinococcosis not receiving placebo treatment