Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

NCT ID: NCT05017194

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2021-12-10

Brief Summary

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

Conditions

Trichuris Trichiura; Infection; Hookworm Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Emodepside 5 mg

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Emodepside 10 mg

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Emodepside 15 mg

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Emodepside 20 mg

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Emodepside 25 mg

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Emodepside 30 mg

Group Type: EXPERIMENTAL

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Albendazole

Group Type: ACTIVE_COMPARATOR

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Placebo

Group Type: PLACEBO_COMPARATOR

Emodepside

Intervention Type: DRUG

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Interventions

Emodepside

Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female adults aged between 18 and 45 years
• Written and signed informed consent
• Examined by a study physician before treatment
• Provided two stool samples at baseline
• Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs

Exclusion Criteria

• Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
• Type 1 and/or 2 diabetes
• Psychiatric disorders
• History of ophthalmological conditions
• Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
• Suffers from severe anaemia (Hb < 80 g/l)
• Received anthelminthic treatment within past four weeks
• Attending other clinical trials during the study
• Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
• Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health Laboratory Ivo de Carneri

OTHER

Sponsor Role: collaborator

Jennifer Keiser

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Keiser

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Public Health Laboratory - Ivo de Carneri

Chake Chake, , Tanzania

Countries

Tanzania

References

Montresor A, Gabrielli AF. Emodepside - A Promising Drug for the Treatment of Soil-Transmitted Helminthiases. N Engl J Med. 2023 May 18;388(20):1907-1908. doi: 10.1056/NEJMe2303793. No abstract available.

Reference Type: DERIVED

PMID: 37195949 (View on PubMed)

Mrimi 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.

Reference Type: DERIVED

PMID: 37195942 (View on PubMed)

Other Identifiers

EMODEP_PEMBA

Identifier Type: -

Identifier Source: org_study_id