Trichuris Trichiura; InfectionPhase 3TREMO-PembaNCT06736691
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
A Phase 3 study testing emodepside (BAY 44-4400) and Mebendazole in people with Trichuris Trichiura; Infection and Hookworm Infection, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Trichuris Trichiura; Infection, Hookworm Infection, Ascaris Lumbricoides Infection
- What is being tested?
- emodepside (BAY 44-4400) and Mebendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteTanzania
- Study dates
- 25 Nov 2025to 16 Sep 2026
- Phase
- Phase 3
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
- T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
- A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
- Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
- Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.
Who cannot join
- Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
- Any of the following:
- Platelet <75,000/mm3
- Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) >3x upper limit of normal (ULN)
- Total bilirubin >2xULN
- Estimated Glomerular Filtration Rate (eGFR) <90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) <90 ml/min (adults)
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- Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
- Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention (detailed list of prohibited medication is provided in Section 6.5.1).
- Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention.
- Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
- Known allergy/hypersensitivity to mebendazole and/or emodepside
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Public Health Laboratory - Ivo de Carneri (PHL-IdC)
Chake Chake
About this study
Official title: A Phase III Single-center, Randomized, Double-blinded, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis
This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.
- Being tested
- emodepside (BAY 44-4400), matching placebo of emodepside, Mebendazole, similar placebo to mebendazole
- Keywords
- Trichuris trichiura, Ascaris lumbricoides, STH, Efficacy, Safety, Hookworm, Emodepside, Soil-transmitted helminths, Roundworm, Whipworm, Mebendazole
- Medical subject headings
- Trichuriasis, Hookworm Infections, Ancylostomiasis, Enterobiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emodepside (BAY 44-4400)Drug
Treatment with single dose of oral 15 mg emodepside
matching placebo of emodepsideDrug
Treatment with single dose of oral emodepside matching placebo
MebendazoleDrug
Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days
similar placebo to mebendazoleDrug
Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Emodepside | Experimental | Not described Receives: Drug: emodepside (BAY 44-4400); Drug: similar placebo to mebendazole |
| Mebendazole | Active comparator | Not described Receives: Drug: matching placebo of emodepside; Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cured of T. trichiura infection
Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit
Measured: Test of Cure Visit at 14 to 21 days after end of treatment
Secondary outcomes (2)
Cured of A. lumbricoides infection
Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit. This endpoint is only applicable for the subgroup of participants co-infected with A. lumbricoides at baseline.
Measured: Test of Cure Visit at 14 to 21 days after end of treatment
Occurrence of TEAEs
Defined as any AE that occurred or worsened after the first dose of study intervention up to 21 days after the last dose of study intervention
Measured: Adverse events that occur after the first dose of study intervention up to 21 days after the last dose of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start25 Nov 2025
- Primary completion1 Jul 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri, Bayer, Coefficient Giving, Ifakara Health Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer Keiser, Professor, Study director, Swiss Tropical & Public Health InstituteSaid Mohammed Ali, MSc, Principal investigator, Public Health Laboratory Ivo de Carneri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736691
- Sponsor's protocol ID
- P2810-23A
- Acronym
- TREMO-Pemba
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a data sharing agreement between Swiss TPH and PHL-IdC in place (study site). Data may be shared with other researchers upon request.
Publications
Taylor L, Ahmada AA, Ali MS, Ali SM, Hattendorf J, Mohammed IS, Keiser J. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial. Lancet. 2024 Aug 17;404(10453):683-691. doi: 10.1016/S0140-6736(24)01403-X.
PubMed 39153818Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825.
PubMed 37195942