Skip to content

A drug intervention trial (praziquantel) against the Schistosoma japonicum parasite in China.

A cluster-randomised trial of combination bovine and human treatment with praziquantel to reduce human infection rates of Schistosom japonicum in volunteer villagers in China

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000263291
Enrollment
3777
Registered
2009-05-14
Start date
2004-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background Zoonotic schistosomiasis japonica is a major public health problem in China. Bovines, particularly water buffaloes, are thought to play a major role in the transmission of schistosomiasis to humans in China. Preliminary results (1998-2003) of a praziquantel (PZQ)-based pilot intervention study we undertook provided proof of principle that water buffaloes are major reservoir hosts for Schistosoma japonicum in the Poyang Lake region, Jiangxi Province. Methods and Findings We undertook a cluster-randomised intervention trial (2004-2007) in Hunan and Jiangxi Provinces in China, with increased power and more general applicability to the lake and marshlands regions of southern China. The trial involved four matched pairs of villages with one village within each pair randomly selected as a control (human PZQ treatment only), leaving the other as the intervention (human and bovine PZQ treatment). A sentinel cohort of people to be monitored for new infections for the duration of the study was selected from each village. Results showed that combined human and bovine chemotherapy with PZQ had a greater effect on human incidence than human PZQ treatment alone. This was supported by Poisson regression analyses yielding crude and adjusted (for water contact) relative risks of 0.5 and 0.54 Conclusions The results from this study supported by previous experimental evidence, confirms that bovines are the major reservoir host of human schistosomiasis in the lake and marshland regions of southern China, and reinforce the rationale for the development and deployment of a transmission blocking anti-S. japonicum vaccine targeting bovines.

Interventions

A combination of bovine and human treatment with the drug praziquantel. Oral dose of 40mg/Kg for humans (as per WHO guidelines);25mg/Kg for water buffaloes and 30 mg/Kg for cattle. Oral tablets once per year for humans for four years. Oral tablets twice per year for bovines for four years.

Sponsors

Donald P McManus
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

a) a resident of the selected village; b) a resident of the village for more than 12 months; c) aged 5–60 years; d) not intending to migrate out of the village for the next 4 years; e) continuously reside in the study area over the study period; f) consent obtained.

Exclusion criteria

Residents who are in the study area only weekends or once a month

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 2, 2026