NCT03527745

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

May 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 6, 2021

Completed
Last Updated

June 12, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 3, 2018

Results QC Date

August 11, 2020

Last Update Submit

May 11, 2023

Conditions

TrichuriasisHookworm Infections

Outcome Measures

Primary Outcomes (1)

  • Cure Rate Against T. Trichiura and Hookworm Infections

    The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).

    14-21 days after treatment

Secondary Outcomes (4)

  • Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively

    14-21 days after treatment

  • Maximum Concentration (Cmax) of Albendazole Sulphoxide

    0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing

  • Time to Reach Cmax (Tmax) of Albendazole Sulphoxide

    0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing

  • Area Under the Curve (AUC) of Albendazole Sulphoxide

    0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing

Study Arms (5)

200 mg albendazole

EXPERIMENTAL

against T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults

Drug: Albendazole

400 mg albendazole

EXPERIMENTAL

against T. trichiura in preschool-aged children, school-aged children and adults or against hookworm infections in preschool-aged children, school-aged children and adults

Drug: Albendazole

600 mg albendazole

EXPERIMENTAL

against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults

Drug: Albendazole

800 mg albendazole

EXPERIMENTAL

against T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults

Drug: Albendazole

Placebo

PLACEBO COMPARATOR

against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults

Drug: Placebo

Interventions

AlbendazoleDRUG

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

Also known as: Zentel®
200 mg albendazole
PlaceboDRUG

Matching placebo tablets will be obtained from Fagron, Germany.

Placebo

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female adults (≥21 years), preschool-aged children (2-5 years) and school-aged children (6-12 years) infected with T. trichiura/hookworm
  • Written informed consent/assent signed from parent/guardian
  • Positive for T. trichiura/hookworm by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
  • Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).

You may not qualify if:

  • Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment and liver function tests.
  • Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
  • Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned test article administration.
  • Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
  • Known or suspected allergy to benzimidazoles.
  • Pregnant (urine testing) or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)

Abidjan, Côte d’Ivoire

Location

Related Publications (2)

  • Patel C, Coulibaly JT, Hofmann D, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and Safety of Albendazole in Hookworm-infected Preschool-aged Children, School-aged Children, and Adults in Cote d'Ivoire: A Phase 2 Randomized, Controlled Dose-finding Trial. Clin Infect Dis. 2021 Jul 15;73(2):e494-e502. doi: 10.1093/cid/ciaa989.

    PMID: 32668456DERIVED

  • Patel C, Coulibaly JT, Schulz JD, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and safety of ascending dosages of albendazole against Trichuris trichiura in preschool-aged children, school-aged children and adults: A multi-cohort randomized controlled trial. EClinicalMedicine. 2020 May 5;22:100335. doi: 10.1016/j.eclinm.2020.100335. eCollection 2020 May.

    PMID: 32405623DERIVED

MeSH Terms

Conditions

TrichuriasisHookworm Infections

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Enoplida InfectionsAdenophorea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsStrongylida InfectionsSecernentea Infections

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Jennifer Keiser, PhD
Organization
Swiss Tropical and Public Health Institute
jennifer.keiser@swisstph.ch
+41 (61) 284 8218

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Jennifer Keiser, PhD

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 17, 2018

Study Start

October 23, 2018

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

June 12, 2023

Results First Posted

January 6, 2021

Record last verified: 2023-05

Locations

CÔ(1)