MedTrace Logo

Albendazole Dose Finding and Pharmacokinetics in Children and Adults

NCT03527745 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2023-06-12

Study results available
· View outcomes & findings →

Summary

This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This study aims at providing evidence on the dose-response of increasing oral albendazole dosages against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years).

The primary objective is to determine cure rates (primary end point, i.e. conversion from being egg positive pre-treatment to egg negative post-treatment). Secondary objectives involve the determination of egg reduction rates (the reduction in the number of excreted eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic parameters will be determined from blood samples collected with a micro-sampling device (secondary end point).

Conditions

  • Trichuriasis
  • Hookworm Infections

Interventions

DRUG

Albendazole

Single dose of albendazole (200mg, dependent on treatment cohort)

DRUG

Albendazole

Single dose of albendazole (400mg, dependent on treatment cohort)

DRUG

Albendazole

Single dose of albendazole (600mg, dependent on treatment cohort)

DRUG

Albendazole

Single dose of albendazole (800mg, dependent on treatment cohort)

DRUG

Placebo

Matching placebo tablets will be obtained from Fagron, Germany.

Sponsors & Collaborators

  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-23
Primary Completion
2019-04-17
Completion
2019-04-17

Countries

  • Côte d’Ivoire

Study Locations

More Related Trials

Entities

Drugs

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 NCT03527745 on ClinicalTrials.gov