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Completed

NCT Number: NCT05538767

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.

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Key information

Conditions

Hookworm Infections Ancylostomiasis Helminthiasis Infections Nematode Infections Parasitic Diseases Secernentea Infections Strongylida Infections

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Public Health Laboratory Ivo de Carneri

Chake Chake, Pemba, 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 12 and 60 years;
  • Written and signed informed consent;
  • Was examined by a study physician before treatment;
  • Provided two stool samples at baseline;
  • Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one 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.
  • Participated in stage I trials of this protocol

Treatment and study plan

Emodepside

Drug

Treatment with Emodepside 30 mg

Albendazole 400mg

Drug

Treatment with Albendazole 400 mg

Primary outcomes

  1. 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 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 of emodepside against Trichuris trichiura and Ascaris lumbricoides

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

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

  3. ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.

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

    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 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).

  4. Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.

    Time frame: At baseline and 14-21 days post-treatment

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 Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2022
Registry last updated
Jun 15, 2023

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.

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