Efficacy and safety of ivermectin and albendazole co-administration in school-aged children and adults infected with Trichuris trichiura: study protocol for a multi-country randomized controlled double-blind trial.

Authors:
Chandni Patel
Chandni Patel
University of Texas Dental Branch at Houston
United States
Jan Hattendorf
Jan Hattendorf
Swiss Tropical and Public Health Institute
Switzerland
Somphou Sayasone
Somphou Sayasone
National Institute of Public Health
Said M Ali
Said M Ali
Public Health Laboratory-Ivo de Carneri
Shaali M Ame
Shaali M Ame
Public Health Laboratory-Ivo de Carneri
Jean T Coulibaly
Jean T Coulibaly
Swiss Tropical and Public Health Institute

BMC Infect Dis 2019 Mar 18;19(1):262. Epub 2019 Mar 18.

Swiss Tropical and Public Health Institute, Basel, Switzerland.

Background: Soil-transmitted helminthiasis affects almost 2 billion people worldwide in tropical climates. Preventive chemotherapy, using the benzimidazoles (albendazole and mebendazole) is the current main recommended control strategy. Nevertheless, there is limited efficacy of these drugs against hookworm infection and, to a greater extent, against trichuriasis. We describe a protocol for a trial investigating the efficacy and safety of the co-administration of ivermectin and albendazole against trichuriasis.

Methods: A double-blind, placebo-controlled randomized controlled trial will be conducted in three countries (Côte d'Ivoire, Tanzania and Lao PDR) with the aim to determine the efficacy, safety and extended effects of co-administered ivermectin and albendazole compared to standard albendazole monotherapy. We will enroll 600 participants aged 6-60 years in each setting. The primary outcome is cure rate (CR) against Trichuris trichiura infection as assessed by Kato-Katz 14-21 days after treatment. Secondary outcomes include CRs against concomitant soil-transmitted helminth (STH) infections (Ascaris lumbricoides, hookworm and Strongyloides stercoralis) and egg reduction rates (ERRs) against STH at 14-21 days, 180 days and 360 days. Tolerability of treatment, infection status assessed by polymerase chain reaction (PCR), and potential benefits of deworming on nutritional and morbidity indicators will be assessed. The primary analysis will include an available-case set and use logistic regression models adjusted for age, sex and weight.

Discussion: This trial will provide robust results on the efficacy and safety of co-administration of ivermectin and albendazole with the aim to better inform WHO recommendations on control of STHs. Furthermore, secondary and explanatory outcomes will provide direct evidence on the extended effects of combination therapy and insight on the relationship between nutrition and morbidity parameters and infection status and intensity.

Trial Registration: NCT03527732 (date assigned: 17 May 2018).

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Source
http://dx.doi.org/10.1186/s12879-019-3882-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6421712PMC
March 2019
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