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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
emodepside (BAY 44-4400)
DrugTreatment with single dose of oral 15 mg emodepside
Mebendazole 100 MG
DrugTreatment with 100 mg mebendazole orally administered b.i.d. for 3 days
similar placebo to mebendazole
DrugTreatment with mebendazole similar placebo orally administered b.i.d. for 3 days
matching placebo of emodepside
DrugTreatment with single dose of oral emodepside matching placebo
Treatment groups
315 Participants
are divided into 2 treatment groupsGroup A: EmodepsideExperimental treatment 2 interventions
Group B: MebendazoleActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cured of T. trichiura infection
Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit
Time frame
Test of Cure Visit at 14 to 21 days after end of treatmentSecondary outcomes
1
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.
Time frame
Time Frame: Test of Cure Visit at 14 to 21 days after end of treatment2
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
Time frame
Adverse events that occur after the first dose of study intervention up to 21 days after the last dose of study interventionOther outcomes
1
Cured of hookworm 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 hookworm at baseline.
Time frame
Test of Cure Visit at 14 to 21 days after end of treatment2
Egg reduction of each species of STH (T. trichiura, A. lumbricoides and hookworm infection)
Defined as logarithm of the number of eggs/g (+1) from stool samples taken at the Test of Cure Visit minus the logarithm of the number of eggs/g (+1) in stool samples taken at baseline. Egg reduction of A. lumbricoides and hookworm will only be calculated in participants co-infected with A. lumbricoides and hookworm at baseline, respectively.
Time frame
Test of Cure Visit at 14 to 21 days after end of treatment3
Listing of individual plasma concentrations of emodepside
Time frame
Plasma concentrations at 3, 6, 21-48 hours and 14-21 days after the end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Swiss Tropical & Public Health Institute
Lead sponsor
Bayer
Collaborator
University of the Philippines
Collaborator
Coefficient Giving (Formerly Open Philanthropy)
Collaborator
Source ClinicalTrials.gov
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