Limited efficacy of repeated praziquantel treatment in Schistosoma mansoni infections as revealed by highly accurate diagnostics, PCR and UCP-LF CAA (RePST trial)

PLoS Negl Trop Dis. 2022 Dec 22;16(12):e0011008. doi: 10.1371/journal.pntd.0011008. eCollection 2022 Dec.

Abstract

Background: Most studies assessing praziquantel (PZQ) efficacy have used relatively insensitive diagnostic methods, thereby overestimating cure rate (CR) and intensity reduction rate (IRR). To determine accurately PZQ efficacy, we employed more sensitive DNA and circulating antigen detection methods.

Methodology: A sub-analysis was performed based on a previously published trial conducted in children from Côte d'Ivoire with a confirmed Schistosoma mansoni infection, who were randomly assigned to a standard (single dose of PZQ) or intense treatment group (4 repeated doses of PZQ at 2-week intervals). CR and IRR were estimated based on PCR detecting DNA in a single stool sample and the up-converting particle lateral flow (UCP-LF) test detecting circulating anodic antigen (CAA) in a single urine sample, and compared with traditional Kato-Katz (KK) and point-of-care circulating cathodic antigen (POC-CCA).

Principal findings: Individuals positive by all diagnostic methods (i.e., KK, POC-CCA, PCR, and UCP-LF CAA) at baseline were included in the statistical analysis (n = 125). PCR showed a CR of 45% (95% confidence interval (CI) 32-59%) in the standard and 78% (95% CI 66-87%) in the intense treatment group, which is lower compared to the KK results (64%, 95% CI 52-75%) and 88%, 95% CI 78-93%). UCP-LF CAA showed a significantly lower CR in both groups, 16% (95% CI 11-24%) and 18% (95% CI 12-26%), even lower than observed by POC-CCA (31%, 95% CI 17-35% and 36%, 95% CI 26-47%). A substantial reduction in DNA and CAA-levels was observed after the first treatment, with no further decrease after additional treatment and no significant difference in IRR between treatment groups.

Conclusion/significance: The efficacy of (repeated) PZQ treatment was overestimated when using egg-based diagnostics (i.e. KK and PCR). Quantitative worm-based diagnostics (i.e. POC-CCA and UCP-LF CAA) revealed that active Schistosoma infections are still present despite multiple treatments. These results stress the need for using accurate diagnostic tools to monitor different PZQ treatment strategies, in particular when moving toward elimination of schistosomiasis.

Clinical trial registration: www.clinicaltrials.gov, NCT02868385.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Anthelmintics* / therapeutic use
  • Antigens, Helminth / analysis
  • Antigens, Helminth / genetics
  • Feces / chemistry
  • Polymerase Chain Reaction
  • Praziquantel / therapeutic use
  • Prevalence
  • Schistosoma mansoni / genetics
  • Schistosomiasis mansoni* / diagnosis
  • Schistosomiasis mansoni* / drug therapy
  • Sensitivity and Specificity

Substances

  • Praziquantel
  • Anthelmintics
  • Antigens, Helminth

Associated data

  • ClinicalTrials.gov/NCT02868385

Grants and funding

This work received financial support from the Prof. Dr. Flu Foundation, based in The Netherlands and the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD) (no. NTDSC087G) to GJD, which is funded at The Task Force for Global Health, primarily by the Bill & Melinda Gates Foundation, by the United States Agency for International Development through its Neglected Tropical Disease Program, and with UK Aid from the British people. The use of the PCR internal control PhHV was supported by the European Virus Archive goes Global (EVAg) project that has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 653316. The funders had no role in the design of the study, data collection, analysis, decision to publish, or preparation of the manuscript.