TrichuriasisPhase 2IverpedNCT06184399
Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC
A Phase 2 study testing Ivermectin 1.5 mg ODT, Ivermectin 3 mg Oral Tablet and Albendazole 400 mg Oral Tablet in people with Trichuriasis and Ascariasis, run by Jennifer Keiser at 1 site in Tanzania.
Trial summary
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Trichuriasis, Ascariasis, Hookworm Infections
- What is being tested?
- Ivermectin 1.5 mg ODT, Ivermectin 3 mg Oral Tablet and Albendazole 400 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteTanzania
- Study dates
- 5 Jun 2024to 9 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Who cannot join
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <70 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., ivermectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- concurrent participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and Acceptability of Ascending Doses of Ivermectin in Combination With Albendazole for Trichuris Trichiura Infections in Preschool-aged Children: a Single-blind Randomised Controlled Dose-ranging Trial
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed oro-dispersible tablets (ODTs) and the standard ivermectin tablets (Stromectol®) will be compared in this age group.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Read the detailed description
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed ODTs and the standard ivermectin tablets (Stromectol®) will be compared in this age group.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among PSAC receiving different doses of ivermectin.
The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens.
In addition, this study aims to characterize population pharmacokinetics of the ivermectin ODTs compared to standard tablets in T. trichiura infected individuals, and to assess the acceptability of the treatments.
After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.
Randomization of participants into the six treatment arms will be stratified according to intensity of infection and age. All participants will be interviewed before treatment, and at 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. Differences among CRs between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight). Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.Using the DoseFinding package of the statistical software environment R, Emax models will be implemented to predict the dose-response curves based on CRs and ERRs.
Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics.
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections
- Being tested
- Ivermectin 1.5 mg ODT, Ivermectin 3 mg Oral Tablet, Albendazole 400 mg Oral Tablet, Placebo Ivermectin ODT
- Keywords
- Ivermectin, Albendazole, Anthelminthics, Trichuris trichiura, Ascaris lumbricoides, Hookworm, Whipworm, Soil-transmitted helminths
- Medical subject headings
- Trichuriasis, Ascariasis, Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin 1.5 mg ODTDrug
Oro-dispersible tablets of 1.5 mg ivermectin
Ivermectin 3 mg Oral TabletDrug
Also called Stromectol®
Tablets of 3 mg ivermectin
Albendazole 400 mg Oral TabletDrug
Also called Zentel®
Tablets of 400 mg albendazole
Placebo Ivermectin ODTDrug
Placebo for ivermectin ODT
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ivermectin ODT Placebo & Albendazole | Placebo comparator | Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Albendazole 400 mg Oral Tablet; Drug: Placebo Ivermectin ODT |
| Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet |
| Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet |
| Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet |
| Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Ivermectin 1.5 mg ODT; Drug: Albendazole 400 mg Oral Tablet |
| Arm F: Ivermectin standard tablets & Albendazole | Active comparator | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Receives: Drug: Ivermectin 3 mg Oral Tablet; Drug: Albendazole 400 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate (CR) Against T. Trichiura
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Measured: 14-21 days post-treatment
Secondary outcomes (9)
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Cure Rate (CR) Against A. Lumbricoides
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Cure Rate (CR) Against Hookworm
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Number of Participants Reporting Adverse Events (AEs)
Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.
Measured: 3 hours, 24 hours and 14-21 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start5 Jun 2024
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrichuriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184399
- Sponsor's protocol ID
- Iverped_1
- Acronym
- Iverped
- Status last verified
- Sep 2025
- First submitted
- 14 Dec 2023
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sprecher VP, Schnoz A, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of ascending doses of orodispersible ivermectin co-administered with albendazole for Trichuris trichiura infections in preschool-aged children in Tanzania: a single-blind, randomised, controlled, dose-ranging, phase 2 trial. Lancet Infect Dis. 2026 Feb;26(2):160-169. doi: 10.1016/S1473-3099(25)00472-4. Epub 2025 Sep 17.
PubMed 40975108
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Acceptability of Ascending Doses of Ivermectin in Combination With Albendazole for Trichuris Trichiura Infections in Preschool-aged Children: a Single-blind Randomised Controlled Dose-ranging Trial
- ClinicalTrials.gov ID
- NCT06184399
- Acronym / sponsor ID
- Iverped / Iverped_1
- Conditions
- Trichuriasis, Ascariasis, Hookworm Infections
- Keywords
- Ivermectin, Albendazole, Anthelminthics, Trichuris trichiura, Ascaris lumbricoides, Hookworm, Whipworm, Soil-transmitted helminths
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed oro-dispersible tablets (ODTs) and the standard ivermectin tablets (Stromectol®) will be compared in this age group.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Detailed description
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed ODTs and the standard ivermectin tablets (Stromectol®) will be compared in this age group.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among PSAC receiving different doses of ivermectin.
The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens.
In addition, this study aims to characterize population pharmacokinetics of the ivermectin ODTs compared to standard tablets in T. trichiura infected individuals, and to assess the acceptability of the treatments.
After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.
Randomization of participants into the six treatment arms will be stratified according to intensity of infection and age. All participants will be interviewed before treatment, and at 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. Differences among CRs between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight). Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.Using the DoseFinding package of the statistical software environment R, Emax models will be implemented to predict the dose-response curves based on CRs and ERRs.
Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ivermectin ODT Placebo & Albendazole | Placebo comparator | Drug: Albendazole 400 mg Oral Tablet, Drug: Placebo Ivermectin ODTPlacebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Experimental | Drug: Ivermectin 1.5 mg ODT, Drug: Albendazole 400 mg Oral TabletCombination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Experimental | Drug: Ivermectin 1.5 mg ODT, Drug: Albendazole 400 mg Oral TabletCombination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Experimental | Drug: Ivermectin 1.5 mg ODT, Drug: Albendazole 400 mg Oral TabletCombination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Experimental | Drug: Ivermectin 1.5 mg ODT, Drug: Albendazole 400 mg Oral TabletCombination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
| Arm F: Ivermectin standard tablets & Albendazole | Active comparator | Drug: Ivermectin 3 mg Oral Tablet, Drug: Albendazole 400 mg Oral TabletCombination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Key exclusion criteria (6 listed)
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <70 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., ivermectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
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 |
|---|---|---|
| Ivermectin 1.5 mg ODTOro-dispersible tablets of 1.5 mg ivermectin | Drug | Arm B: Ivermectin ODT 100 µg/kg & Albendazole, Arm C: Ivermectin ODT 200 µg/kg & Albendazole, Arm D: Ivermectin ODT 300 µg/kg & Albendazole, Arm E: Ivermectin ODT 400 µg/kg & Albendazole |
| Ivermectin 3 mg Oral TabletAlso: Stromectol®Tablets of 3 mg ivermectin | Drug | Arm F: Ivermectin standard tablets & Albendazole |
| Albendazole 400 mg Oral TabletAlso: Zentel®Tablets of 400 mg albendazole | Drug | Arm A: Ivermectin ODT Placebo & Albendazole, Arm B: Ivermectin ODT 100 µg/kg & Albendazole, Arm C: Ivermectin ODT 200 µg/kg & Albendazole, Arm D: Ivermectin ODT 300 µg/kg & Albendazole, Arm E: Ivermectin ODT 400 µg/kg & Albendazole, Arm F: Ivermectin standard tablets & Albendazole |
| Placebo Ivermectin ODTPlacebo for ivermectin ODT | Drug | Arm A: Ivermectin ODT Placebo & Albendazole |
Primary outcome
Cure Rate (CR) Against T. Trichiura
Time frame: 14-21 days post-treatment
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
9 secondary outcomes
Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)
Time frame: 14-21 days post-treatment
Cure Rate (CR) Against A. Lumbricoides
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)
Time frame: 14-21 days post-treatment
Cure Rate (CR) Against Hookworm
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)
Time frame: 14-21 days post-treatment
Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)
Time frame: 14-21 days post-treatment
Number of Participants Reporting Adverse Events (AEs)
Time frame: 3 hours, 24 hours and 14-21 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40975108Sprecher VP, Schnoz A, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of ascending doses of orodispersible ivermectin co-administered with albendazole for Trichuris trichiura infections in preschool-aged children in Tanzania: a single-blind, randomised, controlled, dose-ranging, phase 2 trial. Lancet Infect Dis. 2026 Feb;26(2):160-169. doi: 10.1016/S1473-3099(25)00472-4. Epub 2025 Sep 17.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin 1.5 mg ODT, Ivermectin 3 mg Oral Tablet and Albendazole 400 mg Oral Tablet in people with Trichuriasis and Ascariasis, run by Jennifer Keiser at 1 site in Tanzania.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Sep 2025. 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 Tanzania. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate (CR) Against T. Trichiura (time frame: 14-21 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184399, which also lists 1 linked publication.
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 22 Sep 2025.