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

Summary

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

Conditions

• Soil Transmitted Helminth (STH) Infections

Interventions

DRUG

A single dose of Albendazole 400mg + Ivermectin (200 µg/ kg) combination therapy

Children will receive the medication after being randomly assigned to either treatment arm. Albendazole will be administered as a syrup and ivermectin tablets as powdered tablets because ivermectin suspension is not available in Bangladesh. The commercially available 6 mg unscored Ivermectin tablets will be crushed, the tablet fragments ground into a powder, and stored in an airtight plastic container in a dry, cool environment after all aseptic procedures. According to the weight of the children, the investigators will provide the needed amount (weighted by microgram scale) of the drug mixed with 5 ml of water. The study field staff will help the parents to give the medicine to the child by the direct observation therapy (DOT) method. The parents will be advised to bring the children on an empty stomach in the morning. Ivermectin will be given first, and a light snack will be provided 30 minutes after taking ivermectin. Then albendazole will be given to the children.

DRUG

A single dose of 400 mg Oral Albendazole monotherapy

Albendazole will be given in syrup form. The study field staff will help the parents to give the medicine to the child by the direct observation therapy (DOT) method. The parents will be advised to bring the children on an empty stomach in the morning. Ivermectin will be given first, and a light snack will be provided 30 minutes after taking ivermectin. Then albendazole will be given to the children. Both drugs will be given using direct observation at the field clinic. Parents will be advised to report any adverse effects, including vomiting, after taking the medication. If vomiting occurs within one hour of medication, a redosing will be provided.

Sponsors & Collaborators

• Cures Within Reach

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Principal Investigators

• Syed Nazin Morshed, MBBS · International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-10

Primary Completion

2026-03-31

Completion

2026-07-31

Countries

• Bangladesh

Study Locations