A Comparison of the Diagnostic Capability of Kato-Katz and Real-Time PCR for the Assessment of Treatment Efficacy of Ivermectin and Albendazole Combination Against T. trichiura Infections

Authors

Gabriela Matamoros
Ana Sanchez
Ruben Cimino
Alejandro Krolewiecki
Rojelio Mejia

Publication Date

11-1-2024

Journal

PLOS Neglected Tropical Diseases

DOI

10.1371/journal.pntd.0012677

PMID

39561184

PMCID

PMC11614246

PubMedCentral® Posted Date

11-19-2024

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

Humans, Albendazole, Real-Time Polymerase Chain Reaction, Animals, Anthelmintics, Ivermectin, Female, Male, Trichuriasis, Adult, Trichuris, Treatment Outcome, Young Adult, Adolescent, Middle Aged, Feces, Child, Sensitivity and Specificity, Parasite Egg Count

Abstract

BACKGROUND: Trichuris trichiura is humans' second most prevalent soil-transmitted helminth (STH) infection after Ascaris lumbricoides, affecting approximately 460 million people worldwide. Despite its sub-optimal sensitivity, especially in low prevalence and infection intensity settings, the modified Kato-Katz (K-K) is still recommended as a diagnostic method by the World Health organization (WHO) guidelines.

METHODOLOGY/PRINCIPAL FINDINGS: Within a randomized clinical trial (RCT) comprising four treatment arms with two different anthelmintics, the present study reports an important secondary research objective to determine the diagnostic agreement between K-K and real-time PCR evaluating treatment efficacy against T. trichiura. The parasitological results were analyzed, including cure rates (CR) of a subgroup of 94 participants positive at baseline for T. trichiura eggs for both techniques. The single-dose albendazole (ALB) arm resulted in significantly lower CRs than experimental arms of albendazole/ivermectin (ALB/IVM) combinations. The overall diagnostic agreement between both techniques was 88.7% [κ = 0.8 (P

CONCLUSIONS AND SIGNIFICANCE: These findings indicate that real-time PCR is a suitable alternative for CR estimation in helminthiasis clinical trials. It also highlights the need to identify the most accurate diagnostic tools for RCTs, that would benefit from guiding principles to achieve harmonization across studies and are not necessarily the same as those used for epidemiological surveys.

Comments

TRIAL REGISTRATION: Clinical Trials.gov (NCT04041453)

Associated Data