NCT05453045

Brief Summary

This project will develop and assess the feasibility and acceptability of a salive-based assay to monitor adherence to Mass Drug Administration (MDA) campaigns within Soil-transmitted helminthiasis (STH) control programs, evaluating the salive and serum pharmacokinetics of ALBENDAZOLE (ABZ) and its metabolites.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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 6, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

July 6, 2022

Last Update Submit

July 11, 2022

Conditions

Pharmacological Action

Outcome Measures

Primary Outcomes (1)

  • Salive albendazole levels

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

    72 hours

Study Arms (1)

Albendazole

EXPERIMENTAL

400 mg po single dose

Drug: Albendazole

Interventions

AlbendazoleDRUG

tablet administration after a meal contaning approximate 15 g of fat

Also known as: Albendazole tablet, Albendazole 400mg po
Albendazole

Eligibility Criteria

Age18 Years - 45 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

MeSH Terms

Interventions

Albendazole

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Alejandro J Krolewiecki, MD

CONTACT

+5491131838673alekrol@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 12, 2022

Study Start

July 18, 2022

Primary Completion

August 30, 2022

Study Completion

December 16, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share