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.

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)

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.

The proposed research will include data from 726 subjects, infected with Schistosomiasis and treated according to protocol in one of two arms. The final dataset will include phenotypic data such as demographics and medical history, results of the different diagnostic tests under investigation, clinical signs and symptoms, echography findings on Schistosomiasis induced morbidity, results of indirect morbidity markers under investigation, presence or absence of Plasmodium falciparum (Pf) and of Pf molecular resistance markers. All the individual participant data and additional supporting information will be deposited, after deidentification, at the IDDO - Schistosomiasis/STHs Data Platform. This is a platform specifically for Schistosomiasis/STHs data and is part of the IDDO project, an international collaboration hosted by the University of Oxford. The repository has data access policies and procedures consistent with ITM data sharing policies.

We anticipate to deposit the individual participant data into the IDDO repository as soon as possible after publication of both findings on treatment efficacy and diagnostic accuracy, but no later than within one year. No end date is established for availability and access to the submitted data.

For the first five years from submission of the data, decisions regarding data access for third parties will be taken by the authors in collaboration with the ITM Data Access Committee (DAC). After five years, all requests for access to the Data from third parties shall automatically be delegated to DAC of IDDO. The IDDO DAC will provide controlled access to third party researchers whose applications for Data held within the IDDO repository are approved by the DAC in accordance with specific Data Access Guidelines.

All requests are reviewed for qualifications of the researchers, the design and objectives of the secondary research, analysis plan and publication plan, consistency with ITM data sharing policies, applicable laws and regulations, and required ethics approvals.