Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children (SchistoSAM)

Institute of Tropical Medicine, Belgium

Status and phase: Completed; Phase 3

Conditions: Schistosoma Haematobium; Schistosoma Mansoni

Treatments: Drug: Praziquantel; Drug: Artesunate + Mefloquine

Study type: Interventional

Funder types: Other

Identifiers

NCT03893097

1269/18

Details and patient eligibility

About

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.

The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

Full description

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.

The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

For this purpose, 726 school children, aged 6-14 years old and infected with Schistosoma (as demonstrated by presence of eggs in stool and/or urine) will be randomized in one of the following arms:

1. AM, available in fixed dose tablets of 25/50 mg and 100/200 mg will be administered once daily for three days in a dose closest to 4 mg/kg artesunate and 8 mg/kg mefloquine. This treatment course will be repeated 2 times at 6-week intervals.
2. PZQ, available in tablets of 600 mg, will be administered as a single dose of 40 mg/kg.

Trial participants will be regularly followed-up:

1. At each dose administration
2. At day 7 after each dose for follow-up of safety
3. At week 4, 10 and 16 for parasitological assessment and follow-up of safety
4. At week 6 and 12 for clinical assessment before the second and third drug administration (only in the AM arm)
5. At week 24 and 48 for assessment of Schistosoma spp. and malaria infection and associated morbidity (compared to baseline)

Enrollment: 726 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children ≥6 and ≤14 years of age
2. Enrolled in one of the selected primary schools in the region
3. Infected with schistosomiasis (i.e. Schistosoma spp. eggs in urine and/or stool)
4. Informed consent from parents/guardians signed

Exclusion criteria

1. History of, or ongoing, epilepsy or psychiatric illness (I.e. recent history of depression, generalized anxiety disorder; history of psychosis, schizophrenia or other major psychiatric disorders) or known hypersensitivity to one of the three study drugs
2. Chronic medication for any reason
3. Any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement
4. Any febrile illness
5. Exposure to PZQ or ACT within the three previous months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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726 participants in 2 patient groups

Praziquantel

Active Comparator group

Description:

Participants in this arm will receive one dose of PZQ at baseline at 40 mg/kg.

Treatment:

Drug: Praziquantel

Artesunate-Mefloquine

Experimental group

Description:

Participants in this arm will receive the Artesunate-Mefloquine (fixed-drug)combination at 4 mg/kg artesunate and 8 mg/kg mefloquine at 3 consecutive days. This will be repeated twice; at week 6 and week 12.

Treatment:

Drug: Artesunate + Mefloquine