Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

NCT06184399 | Completed Phase 2 Results

• 1 other identifier: Iverped_1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed oro-dispersible tablets (ODTs) and the standard ivermectin tablets (Stromectol®) will be compared in this age group. As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

Conditions

Trichuriasis; Ascariasis; Hookworm Infections

Keywords

Ivermectin; Albendazole; Anthelminthics; Trichuris trichiura; Ascaris lumbricoides; Hookworm; Whipworm; Soil-transmitted helminths

Outcome Measures

Primary Outcomes (1)

• Cure Rate (CR) Against T. Trichiura

  The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.

  14-21 days post-treatment

Secondary Outcomes (9)

• Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)

  14-21 days post-treatment

• Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)

  14-21 days post-treatment

• Cure Rate (CR) Against A. Lumbricoides

  14-21 days post-treatment

• Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)

  14-21 days post-treatment

• Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)

  14-21 days post-treatment

Other Outcomes (2)

• Blood Concentration of Ivermectin

  0 to 24 hours post-treatment

• Acceptability of ODT Assessed by Visual Analogue Scale (0-100 mm)

  15 min post-treatment

Study Arms (6)

Arm A: Ivermectin ODT Placebo & Albendazole

PLACEBO COMPARATOR

Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Albendazole 400 mg Oral Tablet; Drug: Placebo Ivermectin ODT

Arm B: Ivermectin ODT 100 µg/kg & Albendazole

EXPERIMENTAL

Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet

Arm C: Ivermectin ODT 200 µg/kg & Albendazole

EXPERIMENTAL

Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet

Arm D: Ivermectin ODT 300 µg/kg & Albendazole

EXPERIMENTAL

Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet

Arm E: Ivermectin ODT 400 µg/kg & Albendazole

EXPERIMENTAL

Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet

Arm F: Ivermectin standard tablets & Albendazole

ACTIVE COMPARATOR

Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Ivermectin 3 mg Oral Tablet; Drug: Albendazole 400 mg Oral Tablet

Interventions

Ivermectin 1.5 mg ODT DRUG

Oro-dispersible tablets of 1.5 mg ivermectin

Arm B: Ivermectin ODT 100 µg/kg & Albendazole; Arm C: Ivermectin ODT 200 µg/kg & Albendazole; Arm D: Ivermectin ODT 300 µg/kg & Albendazole; Arm E: Ivermectin ODT 400 µg/kg & Albendazole

Ivermectin 3 mg Oral Tablet DRUG

Tablets of 3 mg ivermectin

Also known as: Stromectol®

Arm F: Ivermectin standard tablets & Albendazole

Albendazole 400 mg Oral Tablet DRUG

Tablets of 400 mg albendazole

Also known as: Zentel®

Arm A: Ivermectin ODT Placebo & Albendazole; Arm B: Ivermectin ODT 100 µg/kg & Albendazole; Arm C: Ivermectin ODT 200 µg/kg & Albendazole; Arm D: Ivermectin ODT 300 µg/kg & Albendazole; Arm E: Ivermectin ODT 400 µg/kg & Albendazole; Arm F: Ivermectin standard tablets & Albendazole

Placebo Ivermectin ODT DRUG

Placebo for ivermectin ODT

Arm A: Ivermectin ODT Placebo & Albendazole

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document)
• having given written informed consent signed by parents/caregivers
• being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
• having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
• being able and willing to be examined by a study physician before and after treatment

You may not qualify if:

• presence or signs of major systemic illness, e.g. fever (temporal body temperature of \>38.0°C), severe anaemia (haemoglobin level of \<70 g/l)
• history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
• use of anthelminthic drugs during study period
• known allergy to study medication (i.e., ivermectin or albendazole)
• being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
• concurrent participation in other clinical trials

Sponsors & Collaborators

• Jennifer Keiser: lead
• Public Health Laboratory Ivo de Carneri: collaborator

Study Sites (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Tanzania

Location

Related Publications (1)

• Sprecher VP, Schnoz A, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of ascending doses of orodispersible ivermectin co-administered with albendazole for Trichuris trichiura infections in preschool-aged children in Tanzania: a single-blind, randomised, controlled, dose-ranging, phase 2 trial. Lancet Infect Dis. 2025 Sep 17:S1473-3099(25)00472-4. doi: 10.1016/S1473-3099(25)00472-4. Online ahead of print.

  PMID: 40975108 DERIVED

MeSH Terms

Conditions

Trichuriasis; Ascariasis; Hookworm Infections; Ancylostomiasis

Interventions

Ivermectin; Albendazole; Tablets

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Ascaridida Infections; Secernentea Infections; Strongylida Infections

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Prof Jennifer Keiser
• Organization: Swiss Tropical and Public Health Institute

jennifer.keiser@swisstph.ch

+41 61 284 82 18

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) Treatment allocation will be masked using appearance-matched placebos.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: June 5, 2024
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Locations

TA (1)