NCT04041427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

July 31, 2019

Last Update Submit

May 10, 2021

Conditions

Helminthiasis

Outcome Measures

Primary Outcomes (2)

  • Urine albendazole levels

    Albendazole and its metabolites will be measured in urine samples through high performance liquid chromatography (HPLC).

    96 hours

  • Serum albendazole levels

    Albendazole and its metabolites will be measured in serum samples obtained from venous blood through HPLC.

    72 hours

Study Arms (3)

Fasting

EXPERIMENTAL

Albendazole 400mg will be ingested by study participants with an 8-hour fasting diet.

Drug: Albendazole Pill

High fat content diet

EXPERIMENTAL

Albendazole 400mg will be ingested by study participants 15 to 30 minutes after a meal with high fat content (40 grams of fat).

Drug: Albendazole PillOther: High fat content diet

Moderate fat content diet

EXPERIMENTAL

Albendazole 400mg will be ingested by study participants 15 to 30 minutes after a meal with moderate fat content (15 grams of fat).

Drug: Albendazole PillOther: Moderate fat content die

Interventions

Albendazole PillDRUG

Albendazole 400mg po

FastingHigh fat content dietModerate fat content diet
High fat content dietOTHER

High fat content diet

High fat content diet
Moderate fat content dieOTHER

Moderate fat content die

Moderate fat content diet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index: 18 to 25.
  • Physical exam without significant abnormal findings

You may not qualify if:

  • Pregnancy
  • Lactation
  • Use of ABZ or other benzimidazole drugs in the previous 30 days.
  • History of intolerance to ABZ.
  • Malabsorption and/or other gastrointestinal conditions that might compromise ABZ absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Investigaciones de Enfermedades Tropicales, UNSalta

Orán, Salta Province, 4530, Argentina

Location

MeSH Terms

Conditions

Helminthiasis

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador CIC CONICET

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 1, 2019

Study Start

July 17, 2019

Primary Completion

September 30, 2019

Study Completion

February 28, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)