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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
315
Treatment with single dose of oral 15 mg emodepside
Treatment with single dose of oral emodepside matching placebo
Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days
Public Health Laboratory - Ivo de Carneri (PHL-IdC)
Chake Chake, Tanzania
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 treatment
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: Test of Cure Visit at 14 to 21 days after end of treatment
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 intervention
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Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days