Skip to main content
OpenTrials
Completed

NCT Number: NCT05017194

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trichuris Trichiura; Infection Adenophorea Infections Ancylostomiasis Enoplida Infections Helminthiasis Hookworm Infections Infections Nematode Infections Parasitic Diseases Secernentea Infections Strongylida Infections Trichuriasis

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Public Health Laboratory - Ivo de Carneri

Chake Chake, 122, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emodepside

Drug

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

Primary outcomes

  1. Cure rate (CR) of emodepside against Trichuris trichiura

    Time frame: In the week between 14 and 21 days post-treatment

    CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.

  2. Cure rate (CR) of emodepside against hookworm

    Time frame: In the week between 14 and 21 days post-treatment

    CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.

Secondary outcomes

  1. Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.

    Time frame: In the week between 14 and 21 days post-treatment

    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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).

  2. CR against Ascaris lumbricoides

    Time frame: In the week between 14 and 21 days post-treatment

    CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.

  3. ERR against Ascaris lumbricoides

    Time frame: In the week between 14 and 21 days post-treatment

    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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).

Sponsors and collaborators

Lead sponsor

Jennifer Keiser

Other

Collaborators

  • Public Health Laboratory Ivo de Carneri

Registry information

Official study title

Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials

Acronym: EMODEP_PEMBA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.