Soil transmitted helminths, Schistosoma spp., Taenia solium
Conditions
Interventions
FDC PZQ simultaneous
FDC PZQ sequential
Sponsors
University of Dar Es Salaam Mbeya College of Health and Allied Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria in Tanzania and Zambia: • Age: Equal to or older than 5 years. • Height: Equal to or greater than 105 cm. • Willing and able to participate in all aspects of the study, including taking oral anthelmintic tablets and providing feedback on adverse events. In addition, participants in Zambia must be willing to provide stool and urine samples. • Willing and able to provide signed informed consent, as approved by the ethics committee, for all adult participants (signature or thumbprint with impartial witness). For children, participation requires the written informed consent of a parent or legal guardian, as well as written assent from the child, in compliance with applicable national and local regulations. • Living in the study communities.
Exclusion criteria
Exclusion criteria: Exclusion criteria in Zambia and Tanzania: • Epidemiological risk of being infected by Loa loa defined as those who have visited any of the following countries at any time: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. • Serious medical illness, defined as participants showing symptoms of acute illness which could hamper the participation in the trial, such as high-grade fever, severe diarrhea, neurological symptoms or others, per investigator’s criteria. • Any condition/situation that prevents the appropriate evaluation and follow-up of the participant, per the investigator’s criteria. • Known hypersensitivity to any component of either study treatment. • Pregnant or in the first week postpartum. • Symptoms compatible with NCC or subcutaneous cysticercosis: Seizures or severe progressive headache not relieved by pain killers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Primary: To characterize the safety profile of the co-administration of FDC and praziquantel in a community-wide mass-drug-administration campaign in two dosing regimens: oSimultaneous single-day co-administration. oSequential 14-day co-administration with Primary objective endpoint: Cumulative incidence of participants who experience = 1 treatment-related AE, related AESI or related SAEs up to Day 45 after the first drug intake for the simultaneous and the sequential co-administration of FDC and praziquantel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: To evaluate the effectiveness of two consecutive annual rounds of community-wide mass-drug administration of FDC and praziquantel given to humans on the prevalence of porcine cysticercosis. With Secondary objective endpoint: Absolute difference in the community-level prevalence of porcine cysticercosis between baseline and 11 months after the second annual round of community-wide mass drug administration with FDC and PZQ administered to humans.;- Exploratory: o To report the number of cases of human taeniasis infection at baseline, 3 and 11 months after each annual round of community-wide mass-drug administration with FDC and PZQ. o To estimate the prevalence of human S. mansoni infection at baseline, 3 and 11 months after each annual round of community-wide mass-drug administration with the FDC and PZQ. o To estimate the prevalence of human S. haematobium infection at baseline, 3 and 11 months after each annual round of community-wide mass-drug administration with the FDC and PZQ. o To estimate the prevalence of human STH infection at baseline, 3 and 11 months after each annual round of community-wide mass-drug administration with the FDC and PZQ. o To report the number of cases of human S. stercoralis infection at baseline, 3 and 11 months after each annual round of community-wide mass-drug administration with the FDC and PZQ. with - Exploratory objectives endpoints: o Frequency of human taeniasis infection, at baseline and at 3 and 11 months after each annual round of human MDA with FDC and PZQ. o Prevalence and 95% CI of S. mansoni infection, at baseline and at 3 and 11 months after each annual round of human MDA with FDC and PZQ. o Prevalence and 95% CI of S. haematobium infection, at baseline and at 3 and 11 months after each annual round of human MDA with FDC and PZQ. o Prevalence and 95% CI of human STH infection, at baseline and at 3 and 11 months after each annual round of human MDA with FDC and PZQ. o Frequency of human S. sterco | — |
Countries
Tanzania, Zambia
Contacts
Public ContactSarah Gabriel
Prof. dept of Translational physiology infectiology and public health
Outcome results
None listed