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

NCT07045493 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: PR-25009
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

• 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

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  The investigators will determine the safety of ivermectin and albendazole combination therapy for STH among preschool-age children (ages 2-5 years old) by assessing severe adverse events (SAEs) assessed by CTCAE v4.0. An adverse event will be defined as severe if it causes or contributes to the death or hospitalization for life-threatening conditions or results in persistent or significant disability or incapacity or a medically significant event. Any SAE occurrence for any child will be considered unsafe for that child.

  Through study completion, an average of 1 year

• Determine statistically significant effect of combination therapy

  The investigators will determine whether the efficacy of ivermectin and albendazole combination therapy has a statistically significant effect (p \< 0.05) on cure rates (CR) and egg reduction rates (ERR) compared to albendazole monotherapy.

  3 weeks, 3 months, 6 months, 9 months, 12 months after baseline enrolment

Secondary Outcomes (3)

• Determine statistically significant effect of combination therapy on patient's nutritional status based on z-scores

  3 months, 6 months, 9 months, 12 months after baseline enrolment

• Correlate and compare changes in CR and ERR at different time points

  3 weeks, 3 months, 6 months, 9 months, 12 months after baseline enrolment

• Determine statistically significant effect of combination therapy on patient's clinical condition (anaemia) based on haemoglobin count

  At Baseline and 3 months after baseline enrolment

Study Arms (2)

Treatment Arm - 1

EXPERIMENTAL

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

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

Treatment Arm - 2

ACTIVE COMPARATOR

A single dose of 400 mg Oral Albendazole monotherapy

Drug: A single dose of 400 mg Oral Albendazole monotherapy

Interventions

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

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.

Treatment Arm - 1

A single dose of 400 mg Oral Albendazole monotherapy DRUG

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.

Treatment Arm - 2

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged within 2-5 years
• Height \> 90 cm and Weight \> 15 kg
• Both Stunted (The WHO-recommended height-for-age Z (HAZ) cut-off point is \<-2 SD) and Healthy children (The WHO-recommended height-for-age Z (HAZ) cut-off point is \>-1 SD)
• Confirmed case of STH having single/co-infection of TT/hookworm/AL
• Clinically healthy
• Not received any medications for STH within the last six months
• Guardians willing to let the children participate voluntarily through informed written consent

You may not qualify if:

• Known severe allergies or adverse reactions to any of the study drugs
• Having any pre-existing chronic disease
• Recent participation in any clinical trials (within 1 year)
• Inability to comply with the study requirements, including follow-up visits and treatment adherence
• Guardians unwilling to let the children participate

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Cures Within Reach: collaborator

Study Sites (1)

International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

Location

Related Publications (24)

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Related Links

• World Health Organization (WHO). Neglected tropical diseases
• Children Without Worms (CWW)
• Organization WH. Soil-transmitted helminthiases: eliminating as public health problem soil-transmitted helminthiases in children: progress report 2001-2010 and strategic plan 2011-2020
• Organization WH. 2030 targets soil-transmitted helminthiases control programs

MeSH Terms

Conditions

Infections

Interventions

Albendazole; Ivermectin; Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Therapeutics

Study Officials

• Syed Nazin Morshed, MBBS

  International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will be a single-blinded clinical trial. The investigators and study physicians will not be blinded. The investigators are not using any placebo arm for this trial; the approach to concealing the treatment arm by random selection of the study participants will avoid selection bias in the study. However, the primary objective of the study is a cure assessment of STH infection, which will be performed based on the egg reduction rate (ERR) with stool samples. To ensure the avoidance of any bias in the test, the laboratory personnel doing the procedures will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a Phase IIa, single-blinded, clinical superiority, randomized controlled trial where the safety and efficacy of ivermectin and albendazole combination therapy will be evaluated compared to the standard medication (albendazole monotherapy) against soil-transmitted helminths amongst the preschool-aged children aged between 2 and 5 years.

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: July 1, 2025
• Study Start: July 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: July 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)