NCT07045493

Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh

ENROLLING BY INVITATION Phase 2 Last updated 14 August 2025

What this trial tests

Phase 2 trial testing A single dose of Albendazole 400mg + Ivermectin (200 µg/ kg) combination therapy in Soil Transmitted Helminth (STH) Infections in 110 participants. Enrolling by invitation.

Timeline

10 July 2025

Primary endpoint
31 March 2026

31 July 2026

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	Phase 2
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	110
Start date	10 July 2025
Primary completion	31 March 2026
Estimated completion	31 July 2026
Sites	1 location across Bangladesh

Drugs / interventions tested

• A single dose of Albendazole 400mg + Ivermectin (200 µg/ kg) combination therapy — full drug profile →
• A single dose of 400 mg Oral Albendazole monotherapy — full drug profile →

Conditions studied

• Soil Transmitted Helminth (STH) Infections — all drugs for Soil Transmitted Helminth (STH) Infections →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 2 to 5, any sex, with Soil Transmitted Helminth (STH) Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background (brief):

1. Burden:

Soil-transmitted helminth (STH) infections are a major public health problem, primarily affecting children. Although STH prevalence has decreased to 14% in Bangladesh, over 47 million preschool- and school-age children still live in high-risk areas.
2. Knowledge gap:

Albendazole shows 94-100% efficacy against A. lumbricoides but only 39-60% against T. trichuria. Ivermectin is also effective against hookworm and T. trichuria. Combining ivermectin with albendazole may be more effective than using either drug alone, but this combined therapy for STH has not yet been studied in Bangladesh.
3. Relevance:

STHs significantly impact children's nutrition, hindering health, growth, cognition, and learning. The national deworming program achieved 98.3% treatment coverage, but only 76.2% of PSAC were dewormed using self-prescribed medicines.

Hypothesis (if any):

The combination therapy of Albendazole and Ivermectin is more effective than Albendazole alone for treating soil-transmitted helminths in preschool-age children in Bangladesh

Objectives:

1. To compare the safety and efficacy of Albendazole and Ivermectin combination therapy with Albendazole monotherapy in preschool-aged children
2. To evaluate post-treatment egg reduction rates for various helminths at different time points
3. To determine the median time to re-infection following different anti-helminth interventions for various STH

Methods:

This Phase IIa single-blinded, randomized controlled trial will evaluate the safety and efficacy of ivermectin and albendazole combination therapy versus standard albendazole monotherapy for STH in 2-5 years in rural Belkuchi, Sirajganj. A total of 110 PSAC with confirmed STH will be randomly assigned to two treatment arms. Field activities and laboratory analysis will use the Kato-Katz technique for microscopic examination.

Outcome measures/variables:

* Evaluate the safety and efficacy of ivermectin and albendazole combination therapy for STH
* Evaluate the statistically significant impact on patient clinical outcomes, cure rate, and egg reduction rate
* Correlate changes in Cure Rate and Egg Reduction Rate for different STH at various time points

Publications & conference data

No peer-reviewed publications indexed yet for this trial.