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

Abstract

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).

Authors+Show Affiliations

Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland. Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.Public Health Laboratory Ivo de Carneri, Chake Chake, Zanzibar, Pemba, Tanzania.Public Health Laboratory Ivo de Carneri, Chake Chake, Zanzibar, Pemba, Tanzania.Swiss Tropical and Public Health Institute, Basel, Switzerland. University of Basel, Basel, Switzerland. Unité de Formation et de Recherche Biosciences, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire. Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.Swiss Tropical and Public Health Institute, Basel, Switzerland. jennifer.keiser@swisstph.ch. University of Basel, Basel, Switzerland. jennifer.keiser@swisstph.ch.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30885157

Citation

Patel, Chandni, et al. "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." BMC Infectious Diseases, vol. 19, no. 1, 2019, p. 262.
Patel C, Hürlimann E, Keller L, et al. 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. BMC Infect Dis. 2019;19(1):262.
Patel, C., Hürlimann, E., Keller, L., Hattendorf, J., Sayasone, S., Ali, S. M., Ame, S. M., Coulibaly, J. T., & Keiser, J. (2019). 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. BMC Infectious Diseases, 19(1), 262. https://doi.org/10.1186/s12879-019-3882-x
Patel C, et al. 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. BMC Infect Dis. 2019 Mar 18;19(1):262. PubMed PMID: 30885157.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Patel,Chandni, AU - Hürlimann,Eveline, AU - Keller,Ladina, AU - Hattendorf,Jan, AU - Sayasone,Somphou, AU - Ali,Said M, AU - Ame,Shaali M, AU - Coulibaly,Jean T, AU - Keiser,Jennifer, Y1 - 2019/03/18/ PY - 2018/11/21/received PY - 2019/03/05/accepted PY - 2019/3/20/entrez PY - 2019/3/20/pubmed PY - 2019/4/26/medline KW - Albendazole KW - Côte d’Ivoire KW - Drug efficacy KW - Drug safety KW - Ivermectin KW - Lao PDR KW - Soil-transmitted helminthiasis KW - Tanzania KW - Trichuris trichiura SP - 262 EP - 262 JF - BMC infectious diseases JO - BMC Infect. Dis. VL - 19 IS - 1 N2 - 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). SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/30885157/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_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-019-3882-x DB - PRIME DP - Unbound Medicine ER -