AscariasisPhase 3FACEIT-FUNCT07873398
Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda
A Phase 3 study testing Albendazole 400mg and Ivermectin 3 mg in people with Ascariasis, run by Jennifer Keiser at 1 site in Uganda.
Trial 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)… Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Ascariasis
- What is being tested?
- Albendazole 400mg and Ivermectin 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2026to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala
Prudence Beinamaryo, Dr., +256-789-548-930, prudenceb13@gmail.com
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- Ascariasis
- Being tested
- Albendazole 400mg, Ivermectin 3 mg
- Keywords
- soil-transmitted helminths, Ascaris lumbricoides, anthelminthic, ivermectin, albendazole
- Medical subject headings
- Ascariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole 400mgDrug
Also called Zentel
Albendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO
Ivermectin 3 mgDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| IVM (200 µg/kg) + ALB (400 mg) | Experimental | A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose. Receives: Drug: Albendazole 400mg; Drug: Ivermectin 3 mg |
| ALB (400mg) | Active comparator | A single tablet of albendazole (400mg), provided as single oral dose. Receives: Drug: Albendazole 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks after treatment
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscariasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective follow-up study nested within an open-label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
- Investigators
- Jennifer Keiser, Prof., Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873398
- Sponsor's protocol ID
- 2283FU
- Acronym
- FACEIT-FU
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is a data sharing agreement between Swiss TPH and Uganda MoH in place. Data may be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07873398
- Acronym / sponsor ID
- FACEIT-FU / 2283FU
- Conditions
- Ascariasis
- Keywords
- soil-transmitted helminths, Ascaris lumbricoides, anthelminthic, ivermectin, albendazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective follow-up study nested within an open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| IVM (200 µg/kg) + ALB (400 mg) | Experimental | Drug: Albendazole 400mg, Drug: Ivermectin 3 mgA single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose. |
| ALB (400mg) | Active comparator | Drug: Albendazole 400mgA single tablet of albendazole (400mg), provided as single oral dose. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole 400mgAlso: ZentelAlbendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO | Drug | ALB (400mg), IVM (200 µg/kg) + ALB (400 mg) |
| Ivermectin 3 mgAlso: Stromectol, MectizanWorld 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. | Drug | IVM (200 µg/kg) + ALB (400 mg) |
Primary outcome
Egg Reduction Rates (ERRs) for A. lumbricoides infection at 3 weeks post-treatment
Time frame: 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.
4 secondary outcomes
Number of participants A. lumbricoides egg negative at 3 weeks post-treatment (cured)
Time frame: 3 weeks after treatment
Number of participants egg negative at 3 weeks with soil-transmitted helminth infections 3 months post-treatment (reinfected)
Time frame: 3 months after treatment
Number of participants with concomitant soil-transmitted helminth infections egg negative at 3 weeks post-treatment (cured)
Time frame: 3 weeks after treatment
Egg-reduction Rates (ERRs) against concomitant soil-transmitted helminth infections
Time frame: 3 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. There is a data sharing agreement between Swiss TPH and Uganda MoH in place. Data may be shared with other researchers upon request.
Related trials for Ascariasis
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Keiser, Prof. principal investigator
Swiss Tropical & Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole 400mg and Ivermectin 3 mg in people with Ascariasis, run by Jennifer Keiser at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Keiser, Prof. (+41 61 284 82 18, jennifer.keiser@swisstph.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Egg Reduction Rates (ERRs) for A. lumbricoides infection at 3 weeks post-treatment (time frame: 3 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.