Efficacy and safety of ascending doses of moxidectin against Strongyloides stercoralis infections in adults: a randomised, parallel-group, single-blinded, placebo-controlled, dose-ranging, phase 2a trial

Hofmann, Daniela; Sayasone, Somphou; Sengngam, Khanpaseuth; Chongvilay, Bounthunh; Hattendorf, Jan; Keiser, Jennifer

doi:10.1016/s1473-3099(20)30691-5

Cited by 40 publications

(42 citation statements)

References 24 publications

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“…Figure 1 reports the study flow for the selection of observational studies (A) and RCTs (B). The literature search identified nine RCT [9][10][11][12][13][14][15][16][17], six of which included in a Cochrane systematic review [8], the remaining three were published afterwards [12][13][14], and 13 observational studies [18][19][20][21][22][23][24][25][26][27][28][29]. Hence, overall there were 22 studies included in this review.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…Nine studies [12-14, 16, 17, 20-22, 30] reported the number of patients with and without symptoms. Among them, four studies were conducted in endemic areas [12,14,16,30] and five in a non-endemic setting [13,17,[20][21][22]. Overall, according to the pooled proportions, symptoms were reported in 50.4% cases (95% CI 47.6 -53.1) (Figure 2), with a significant difference in the proportion of individuals reporting symptoms between settings (Figure 2A): 58.6% (95% CI 55.0-62.2) in non-endemic versus 35.7% (95% CI 31.4-39.9) in endemic areas.…”

Section: Evaluation Of Symptomsmentioning

confidence: 99%

“…Post-treatment evaluation was available only for three RCTs conducted in non-endemic areas [9,13,24], and two conducted in endemic areas [10,14]. The latter two included a study comparing a single dose of µg/kg ivermectin with albendazole 400 mg/day for 3 days, and a phase 2a trial comparing ascending doses of moxidectin with placebo [14]. All the other studies included a single dose ivermectin, either as single treatment [24], or in comparison to multiple doses [9,13].…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

“…The time-points for follow up ranged from 24 days and 12 months, and frequency of all symptoms was reduced compared to baseline (Figure 4). Hofmann et al [14] reported also a follow-up after treatment of 3 and 24 hours after treatment, but these time points were not considered here (they were deemed important to collect data about adverse events due to treatment). Symptoms that completely/almost completely cleared at follow up were diarrhea and difficulty in maintaining weight.…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

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Clinical and laboratory features of Strongyloides stercoralis infection at diagnosis and after treatment: a systematic review and meta-analysis

Buonfrate

Fittipaldo

Vlieghe

et al. 2021

Clinical Microbiology and Infection

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Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Evaluation Of Symptomsmentioning

confidence: 99%

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

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Clinical and laboratory features of Strongyloides stercoralis infection at diagnosis and after treatment: a systematic review and meta-analysis

Buonfrate

Fittipaldo

Vlieghe

et al. 2021

Clinical Microbiology and Infection

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“…Evaluation of the risk-benefit ratio. Albendazole, ivermectin and moxidectin are well-known drugs and have little and mainly mild AEs as described to date (e.g., headache, abdominal pain) 7,10,20,[33][34][35]38 . Albendazole and ivermectin are widely used drugs in mass treatment programs against filariasis while only moxidectin is a relatively new drug, FDA-approved against onchocerciasis 39 .…”

Section: Description Of Statistical Methodsmentioning

confidence: 99%

Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol

et al. 2021

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Background: Infections with soil-transmitted helminths (STHs) predominantly affect impoverished populations in tropical environments. The periodic administration of single dose benzimidazoles (i.e., albendazole, mebendazole) to at-risk individuals in endemic regions is at the center of STH control strategies. Given the low efficacy of these drugs against trichuriasis, investigation of drug combinations including moxidectin and ivermectin has recently been initiated, yet the identification of the best treatment option requires more research. We present the protocol for a trial investigating the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole against Trichuris trichiura. Methods: We will conduct a randomized controlled trial enrolling 540 T. trichiura-infected adolescents aged 12-19 years on Pemba Island (Tanzania). The primary objective is to demonstrate non-inferiority of orally co-administered single-dose moxidectin (8 mg)/albendazole (400 mg) compared to orally co-administered single-dose ivermectin (200 µg/kg)/albendazole (400 mg) in terms of egg reduction rates (ERRs) against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment. Secondary objectives include the assessment of the drug combinations’ superiority compared to their respective monotherapies, of the cure rates (CRs) against T. trichiura, and the safety and tolerability of all treatments, as well as CRs and ERRs against concomitant STH infections (Ascaris lumbricoides and hookworm). Potential effects of the treatment regimens on follow-up prevalences of STH at 5-6 weeks and 3 months post-treatment, infection status derived by quantitative polymerase chain reaction (qPCR), and pharmacokinetic/ pharmacodynamic parameters will also be assessed. Furthermore, a subsample of stool specimens will be analyzed by an updated version of the FECPAKG2 platform. Conclusions: Results from this trial will help to inform decision- and policymakers on which anthelminthic combination therapy might improve existing deworming programs and provide a valuable adjunct tool for interrupting STH transmission. Clinicaltrials.gov registration: NCT04700423 (07/01/2021)

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Strongyloides stercoralis

Czeresnia

Weiss

2022

Lung

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Strongyloidiasis has been estimated to affect over 600 million people worldwide. It is caused by Strongyloides stercoralis , a roundworm endemic to the tropics and subtropics, especially areas where sanitation is suboptimal Autochthonous transmission has been documented in rural areas of the USA and Europe. Humans are infected when larvae penetrate the skin or are ingested. Autoinfection, in which larvae generated in the host go on to re-infect the host, leads to a state of chronic asymptomatic infection often with eosinophilia. Hyperinfection syndrome may develop when patients develop immune suppression, due to medications such as corticosteroids or following solid-organ transplantation. Hyperinfection is characterized by exponential increase in parasitic burden, leading to tissue invasion and life-threatening disease and associated bloodstream infections due to enteric organisms. Cases following use of corticosteroids for COVID-19 pneumonia have been described. Strongyloidiasis can be diagnosed by direct visualization of larvae in stool or other body fluids, or by serology. Ivermectin is highly effective in treating the disease. Patients with exposure to endemic areas and those expected to become immune suppressed should be screened and treated before starting immune suppressive agents. Empiric treatment should be considered when timely testing is not readily available.

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Efficacy and safety of ascending doses of moxidectin against Strongyloides stercoralis infections in adults: a randomised, parallel-group, single-blinded, placebo-controlled, dose-ranging, phase 2a trial

Cited by 40 publications

References 24 publications

Clinical and laboratory features of Strongyloides stercoralis infection at diagnosis and after treatment: a systematic review and meta-analysis

Clinical and laboratory features of Strongyloides stercoralis infection at diagnosis and after treatment: a systematic review and meta-analysis

Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol

Strongyloides stercoralis

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