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Urine Albendazole Levels for Coverage Assessment

NCT04041427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-05-11

No results posted yet for this study

Summary

This project will develop and assess the feasibility and acceptability of a urine-based assay to monitor adherence to Mass Drug Administration (MDA) campaigns within Soil-transmitted helminthiasis (STH) control programs, evaluating the urine and serum pharmacokinetics of ALBENDAZOLE (ABZ) and its metabolites across a variety of food/fast conditions, age, gender and body weight. The final goal is to obtain a field ready tool for the measurement of adherence to anthelmintic treatment at a community level that serves as a coverage/adherence indicator and a reference standard for other monitoring tools.

Conditions

  • Helminthiasis

Interventions

DRUG

Albendazole Pill

Albendazole 400mg po

OTHER

High fat content diet

High fat content diet

OTHER

Moderate fat content die

Moderate fat content die

Sponsors & Collaborators

  • Fundacion Mundo Sano

    collaborator UNKNOWN

  • CIVETAN-Tandil, UNCPBA

    collaborator UNKNOWN

  • Natural History Museum, London, UK

    collaborator UNKNOWN

  • Universidad Nacional de Salta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2019-09-30
Completion
2020-02-28

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041427 on ClinicalTrials.gov