Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorSwiss Tropical & Public Health Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Platelet <75,000/mm3
Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) >3x upper limit of normal (ULN)
Total bilirubin >2xULN
Trial design
Treatments tested in this trial
- emodepside (BAY 44-4400)
- Mebendazole 100 MG
- similar placebo to mebendazole
- matching placebo of emodepside
Treatment groups
315 Participants
are divided into 2 treatment groupsSponsors and collaborators
Swiss Tropical & Public Health Institute
Lead sponsor
Bayer
Collaborator
Silicon Valley Community Foundation
Collaborator
University of the Philippines
Collaborator
Source ClinicalTrials.gov