Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura

NCT06037876 | Completed Phase 3

• 1 other identifier: BRCCH PII 2021
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years. The main questions it aims to answer are:

• Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against T. trichiura infections in children aged 6-12 years in Uganda?
• Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against co-infecting soil-transmitted helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12 years in Uganda?
• Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole monotherapy in children aged 6-12 years in Uganda? Participants will be asked to provide two stool samples at baseline that will be subjected to microscopic analysis using the Kato-Katz thick smear technique for detection of soil-transmitted helminth eggs. T. trichiura-infected participants will be:
• clinically examined for general health, anthropometric parameters including height and weight as well as temperature
• randomly assigned to either receive one single oral dose of combined ivermectin and albendazole or albendazole monotherapy
• checked for any potential adverse events and will undergo a brief questionnaire on specific symptoms 3h after drug administration
• asked to provide another two stool samples to be microscopically examined for helminth eggs 14-21 days post-treatment Researchers will compare individuals treated with ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura egg-negative individuals and/or reduction in egg counts differs between these two groups 14-21 days after treatment.

Conditions

Trichuriasis

Keywords

Soil-transmitted helminths, Trichuris trichiura

Outcome Measures

Primary Outcomes (1)

• Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)

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

  14-21 days after treatment

Secondary Outcomes (3)

• Egg Reduction Rate (ERR) against T. Trichiura

  14-21 days after treatment

• Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)

  14-21 days after treatment

• Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections

  14-21 days after treatment

Study Arms (2)

IVM (200 µg/kg) + ALB (400 mg)

EXPERIMENTAL

A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose.

Drug: IVM (200 µg/kg) + ALB (400 mg)

ALB (400mg)

ACTIVE COMPARATOR

A single tablet of albendazole (400mg), provided as single oral dose.

Drug: ALB (400mg)

Interventions

IVM (200 µg/kg) + ALB (400 mg) DRUG

World Health Organization Pre-Qualification (WHO PQ) recommended ivermectin 3mg tablets will be used together with albendazole 400mg tablets as provided by WHO for Neglected Tropical Disease (NTD) programs.

Also known as: Zentel® and Stromectol®, Ivermectin Tablet 3mg

IVM (200 µg/kg) + ALB (400 mg)

ALB (400mg) DRUG

Albendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO

Also known as: Zentel®

ALB (400mg)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent for participation signed from caregivers; and written assent by participants.
• Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and at follow-up assessment 14-21 days after treatment.
• Willing to be examined by a study nurse/physician prior to treatment.
• At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura.

You may not qualify if:

• Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, clinical malaria (fever + positive RDT) upon initial clinical assessment.
• Recent use of anthelmintic drug (within past 4 weeks).
• Attending other experimental research studies.
• Known allergy to study medications (i.e. benzimidazole or ivermectin).

Sponsors & Collaborators

• Jennifer Keiser: lead
• Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda: collaborator

Study Sites (1)

Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health

Kampala, P.O.Box 1661, Uganda

Location

Related Publications (1)

• Palmeirim MS, Hurlimann E, Beinamaryo P, Kyarisiima H, Nabatte B, Hattendorf J, Steinmann P, Keiser J. Efficacy and safety of albendazole alone versus albendazole in combination with ivermectin for the treatment of Trichuris trichiura infections: An open-label, randomized controlled superiority trial in south-western Uganda. PLoS Negl Trop Dis. 2024 Nov 26;18(11):e0012687. doi: 10.1371/journal.pntd.0012687. eCollection 2024 Nov.

  PMID: 39591454 DERIVED

MeSH Terms

Conditions

Trichuriasis

Interventions

Intravital Microscopy; Albumins; Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Proteins; Amino Acids, Peptides, and Proteins; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation concealment will be warranted using sequential, opaque, sealed envelopes. Outcome assessors in the lab will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Parallel open-label randomized controlled superiority trial

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: October 9, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 14, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

UG (1)