Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda

NCT07873398 — Phase 3, Not yet recruiting, 450 participants, Jennifer Keiser

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Change in Soil-transmitted Helminth Infection Intensity Following Mass Drug Administration With Ivermectin Plus Albendazole or Albendazole Alone in Ugandan Schoolchildren: a Follow-up Study to Assess Potential Drug Resistance

Registry	NCT07873398, acronym FACEIT-FU
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	450 (Estimated)
Sponsor	Jennifer Keiser (Other); collaborators: Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
Conditions	Ascariasis
Interventions	Albendazole 400mg, Ivermectin 3 mg (Drug)
Dates	start 2026-10-01 (estimated), primary completion 2026-11-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-10-14, last updated 2026-10-14
Locations	1 site in Uganda

-Summary

The goal of this prospective follow-up study nested within an open-label randomized controlled trial is to investigate the unexpectedly high prevalence of Ascaris lumbricoides infection observed 3-4 months after school-based mass drug administration with ivermectin plus albendazole (IVM-ALB) or albendazole alone (ALB) in Kisoro District, South-Western Uganda. By assessing initial treatment response and subsequent infection dynamics, the study will help clarify whether reduced drug efficacy, suboptimal treatment coverage, reinfection, or a combination of these factors may explain the previous findings.

The main questions the study aims to answer are:

* How effective are IVM-ALB and ALB against A. lumbricoides at 3 weeks, based on egg reduction and cure rates?
* How often do A. lumbricoides and other soil-transmitted helminth infections recur by 3 months?
* How effective are the treatments against Trichuris trichiura and hookworm?
* What can genetic characterization of Ascaris eggs reveal about parasite populations and potential drug resistance markers?

The study will enrol 450 pupils aged 5-14 years from three primary schools, which participated in the previous mass drug administration evaluation. In each school, 150 pupils will be randomly assigned equally to receive a single oral dose of:

* ivermectin (200 µg/kg) plus albendazole (400 mg); or
* albendazole (400 mg) alone.

Each treatment arm will include 225 pupils overall. Children will be included regardless of baseline infection status, following parental/guardian informed consent and child assent. Other pupils will receive routine albendazole under national deworming guidelines.

Stool samples will be collected before treatment and at 3 weeks and 3 months. Duplicate Kato-Katz thick smears will quantify A. lumbricoides, T. trichiura and hookworm eggs. The primary outcome is the arithmetic mean egg reduction rate for A. lumbricoides at 3 weeks. Secondary outcomes include cure rates at 3 weeks, reinfection rates at 3 months, egg reduction and cure rates for T. trichiura and hookworm, and genetic characterization of Ascaris populations and potential resistance markers. Adverse events will be recorded through passive safety monitoring.

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+Arms and interventions

Arm	Type	Interventions	Description
IVM (200 µg/kg) + ALB (400 mg)	Experimental	Drug: Albendazole 400mg; Drug: Ivermectin 3 mg	A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose.
ALB (400mg)	Active comparator	Drug: Albendazole 400mg	A single tablet of albendazole (400mg), provided as single oral dose.

Albendazole 400mg (Drug), also known as Zentel: Albendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO
Ivermectin 3 mg (Drug), also known as Stromectol, Mectizan: 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.

+Outcome measures

Primary outcomes

Egg Reduction Rates (ERRs) for A. lumbricoides infection at 3 weeks post-treatment [3 weeks after treatment]: Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the duplicate Kato-Katz thick smears and multiplying this number by a factor of twelve. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment. Egg reduction for A. lumbricoides infection will then be calculated as change in egg counts from baseline to 3 weeks post-treatment.

Secondary outcomes

Number of participants A. lumbricoides egg negative at 3 weeks post-treatment (cured) [3 weeks after treatment]: The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Number of participants egg negative at 3 weeks with soil-transmitted helminth infections 3 months post-treatment (reinfected) [3 months after treatment]: Number of participants that converted from egg negative with Ascaris lumbricoides, Trichuris trichiura and/or hookworm infections at 3 weeks post-treatment to egg positive after 3 months.
Number of participants with concomitant soil-transmitted helminth infections egg negative at 3 weeks post-treatment (cured) [3 weeks after treatment]: Number of participants that converted from egg positive with Trichuris trichiura and/or hookworm infections to egg negative after 3 weeks.
Egg-reduction Rates (ERRs) against concomitant soil-transmitted helminth infections [3 weeks after treatment]: Percent change in arithmetic and geometric mean eggs per gram of stool from before to after treatment. ERRs will be calculated for Trichuris trichiura and hookworm infections as described in outcome 1.

+Eligibility

Sex: All, ages: 5 Years to 14 Years, accepts healthy volunteers

Inclusion Criteria:

* Informed consent provided by parent/guardian and assent provided by pupil
* School-aged children (5-14 years) enrolled in the respective study schools
* Able and willing to provide a stool sample before and 3 weeks and 3 months post-treatment

Exclusion Criteria:

* Presence or signs of major systemic illness
* Recent use of anthelmintic drugs in the 4 weeks before treatment
* Known allergy to study medication (i.e. benzimidazoles or ivermectin)
* Participation in other clinical trials

+Locations (1)

Facility	City	Country	Status
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health	Kampala	Uganda

+Investigators

Jennifer Keiser, Prof., Principal investigator, Swiss Tropical & Public Health Institute