Trichuris Trichiura; InfectionPhase 2OXA-TRINCT06720259
Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura
A Phase 2 study testing Oxantel Pamoate and Mebendazole in people with Trichuris Trichiura; Infection and Hookworm Infection, run by Jennifer Keiser at 1 site in Tanzania.
Trial summary
This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Trichuris Trichiura; Infection, Hookworm Infection, Ascaris Lumbricoides Infection
- What is being tested?
- Oxantel Pamoate and Mebendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteTanzania
- Study dates
- 16 Apr 2025to 28 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 2 and 12 years.
- Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child.
- Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively.
- At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline.
- Willing to be examined by a study physician prior to treatment.
Who cannot join
- Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level <80 g/L according to WHO) upon initial clinical assessment.
- Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients).
- Use of anthelminthic drugs within 4 weeks before or during study period.
- Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
- Actively participating in other clinical trials during the study.
- Pregnancy (female participants that report to have reached menarche
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years
This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.
- Being tested
- Oxantel Pamoate, Mebendazole
- Medical subject headings
- Trichuriasis, Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxantel PamoateDrug
Tablets containing 250 mg oxantel pamoate
MebendazoleDrug
Tablets containing 500 mg mebendazole
| Study group | Role | What they receive |
|---|---|---|
| Oxantel Single Dose | Experimental | Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0 Receives: Drug: Oxantel Pamoate |
| Oxantel Multiple Dose | Experimental | Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2 Receives: Drug: Oxantel Pamoate |
| Mebendazole Single Dose | Active comparator | Mebendazole (500mg), orally administered on day 0 Receives: Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Measured: 14-21 days after treatment
Secondary outcomes (5)
Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura
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 after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Measured: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Measured: 14-21 days after treatment
Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Measured: 14-21 days after treatment
Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole
Participants will be monitored at the site for 3 hours following treatment for any acute AEs. Participants will be interviewed 3 hours after treatment, as well as 24 hours after every dose received, as well as 14-21days after the last treatment dose about the occurrence of AEs.
AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Measured: 3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start16 Apr 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trichuris Trichiura; InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 163 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
- Investigators
- Jennifer Keiser, PhD, Study chair, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720259
- Sponsor's protocol ID
- OXA-TRI_1
- Acronym
- OXA-TRI
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeanguenat H, Schnoz A, Amour AK, Ahmada AA, Seif SN, Mohammed IS, Hattendorf J, Ali SM, Keiser J. Efficacy, safety, and acceptability of a child-friendly, chewable formulation of oxantel pamoate versus mebendazole for Trichuris spp infections in children aged 2-12 years in Tanzania: a randomised, single-blind, phase 2 trial. Lancet Infect Dis. 2026 Jul 22:S1473-3099(26)00238-0. doi: 10.1016/S1473-3099(26)00238-0. Online ahead of print.
PubMed 42486129
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years
- ClinicalTrials.gov ID
- NCT06720259
- Acronym / sponsor ID
- OXA-TRI / OXA-TRI_1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 6 Dec 2024 (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.
This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxantel Single Dose | Experimental | Drug: Oxantel PamoateTreatment with oxantel pamoate (20 mg/kg), orally administered on day 0 |
| Oxantel Multiple Dose | Experimental | Drug: Oxantel PamoateTreatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2 |
| Mebendazole Single Dose | Active comparator | Drug: MebendazoleMebendazole (500mg), orally administered on day 0 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged between 2 and 12 years.
- Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child.
- Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively.
- At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline.
- Willing to be examined by a study physician prior to treatment.
Key exclusion criteria (6 listed)
- Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level <80 g/L according to WHO) upon initial clinical assessment.
- Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients).
- Use of anthelminthic drugs within 4 weeks before or during study period.
- Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
- Actively participating in other clinical trials during the study.
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 |
|---|---|---|
| Oxantel PamoateTablets containing 250 mg oxantel pamoate | Drug | Oxantel Multiple Dose, Oxantel Single Dose |
| MebendazoleTablets containing 500 mg mebendazole | Drug | Mebendazole Single Dose |
Primary outcome
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
Time frame: 14-21 days after treatment
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
5 secondary outcomes
Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura
Time frame: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura
Time frame: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura
Time frame: 14-21 days after treatment
Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants
Time frame: 14-21 days after treatment
Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole
Time frame: 3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 42486129Jeanguenat H, Schnoz A, Amour AK, Ahmada AA, Seif SN, Mohammed IS, Hattendorf J, Ali SM, Keiser J. Efficacy, safety, and acceptability of a child-friendly, chewable formulation of oxantel pamoate versus mebendazole for Trichuris spp infections in children aged 2-12 years in Tanzania: a randomised, single-blind, phase 2 trial. Lancet Infect Dis. 2026 Jul 22:S1473-3099(26)00238-0. doi: 10.1016/S1473-3099(26)00238-0. Online ahead of print.
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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.
Jennifer Keiser, PhD study chair
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 2 study testing Oxantel Pamoate and Mebendazole in people with Trichuris Trichiura; Infection and Hookworm Infection, 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 8 Jun 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) of oxantel pamoate single dose compared to mebendazole T. trichiura (time frame: 14-21 days after 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 NCT06720259, 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 8 Jun 2025.