A Phase 3 interventional study of Albendazole 400mg and Ivermectin 3 mg in Ascariasis, sponsored by Jennifer Keiser. Not yet recruiting at 1 site in Uganda. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Jennifer Keiser · Phase 3, Interventional, and Treatment
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:
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:
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.
Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose.
Drug: Albendazole 400mg · Drug: Ivermectin 3 mg
A single tablet of albendazole (400mg), provided as single oral dose.
Drug: Albendazole 400mg
Albendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO
Also known as: Zentel
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.
Also known as: Stromectol, Mectizan
Egg Reduction Rates (ERRs) for A. lumbricoides infection at 3 weeks post-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.
Time frame: 3 weeks after treatment
Number of participants A. lumbricoides egg negative at 3 weeks post-treatment (cured)
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Time frame: 3 weeks after treatment
Number of participants egg negative at 3 weeks with soil-transmitted helminth infections 3 months post-treatment (reinfected)
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.
Time frame: 3 months after treatment
Number of participants with concomitant soil-transmitted helminth infections egg negative at 3 weeks post-treatment (cured)
Number of participants that converted from egg positive with Trichuris trichiura and/or hookworm infections to egg negative after 3 weeks.
Time frame: 3 weeks after treatment
Egg-reduction Rates (ERRs) against concomitant soil-transmitted helminth infections
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.
Time frame: 3 weeks after treatment
Plan to share: No — There is a data sharing agreement between Swiss TPH and Uganda MoH in place. Data may be shared with other researchers upon request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin
Ascariasis
Jennifer Keiser