Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12–24 Months of Age

Joseph, Serene A.; Montresor, Antonio; Casapía, Martín; Pezo, Lidsky; Gyorkos, Theresa W.

doi:10.4269/ajtmh.15-0816

Cited by 8 publications

(6 citation statements)

References 14 publications

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“…Despite these limitations, this evaluation provides a unique “snapshot” of deworming practices in settings where deworming and vitamin A supplementation programs are implemented. Assessments of drug safety for preventive chemotherapy are usually done in carefully-monitored research studies, focusing on pharmacologic reactions and adverse medical events that occur hours or days after administration [ 15 , 29 , 33 ]. In contrast, this evaluation provides information on practices and experiences during deworming in program settings.…”

Section: Discussionmentioning

confidence: 99%

“…The benefits of mass deworming are well-documented [ 1 , 2 , 7 , 11 ], although population-level effects may be hard to measure when STH prevalence is low [ 12 – 14 ]. Single doses of albendazole or mebendazole are safe and effective for preventive chemotherapy [ 15 , 16 ]. In STH-endemic countries, these drugs are most commonly available as chewable tablets.…”

Section: Introductionmentioning

confidence: 99%

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Risk of adverse swallowing events and choking during deworming for preschool-aged children

et al. 2018

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BackgroundIn areas where the prevalence of soil-transmitted helminthiasis (STH) is >20%, the World Health Organization (WHO) recommends that deworming medication be given periodically to preschool-age children. To reduce risk of choking-related deaths in children <3 years old, WHO recommends that deworming tablets be crushed and given with water. Little is known about how widely this is practiced or its effectiveness.Methodology and principal findingsAlbendazole distributions for STH were observed for children 1–4 years old in 65 sites in India and Haiti. Information was recorded on child demographics; child demeanor immediately before, as well as struggling or resistance during albendazole administration; tablet form (i.e., crushed or not); and adverse swallowing events (ASEs), including choking, spitting; coughing; gagging; vomiting; and expelling a crushed tablet in a “cloud” of powder. Of 1677 children observed, 248 (14.8%) had one or more ASEs. ASE risk was 3.6% with whole tablets, 25.4% with crushed tablets, and 34.6% when crushed tablets were mixed with water. In multivariate analysis, ASE risk was significantly associated with children 1 year (OR 2.7) or 2 years (OR 2.9) of age; male gender (OR 1.6); non-content child demeanor (fearful, fussy, or combative) before albendazole administration (OR 4.3); child struggling when given albendazole (OR 2.1); and giving water, either after the tablet or mixed with it (OR 5.8). Eighteen (1.1%) children choked, none fatally; 17 choking incidents occurred with crushed tablets. In a multivariate analysis that controlled for distribution site, the only significant risk factor for choking was non-content demeanor (OR 20.6).Conclusions and significanceDeworming-related choking deaths in young children are preventable. In our sample, risk of choking could have been reduced by 79.5% if deworming tablets were not given to young children who were fussy, fearful, or combative or who struggled to resist tablet administration, with only an 18.4% reduction in drug coverage.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Risk of adverse swallowing events and choking during deworming for preschool-aged children

et al. 2018

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“…The incidence of TEAEs in the present study (6.3%) was lower than in a previous safety study (11%) with an earlier version of MBZ chewable tablet. 13 , 26 All TEAEs were considered mild or moderate and most were not considered related to MBZ administration. The present study also demonstrated that MBZ can be used safely in children aged 12–36 months.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of a Single-Dose Mebendazole 500 mg Chewable, Rapidly-Disintegrating Tablet for Ascaris lumbricoides and Trichuris trichiura Infection Treatment in Pediatric Patients: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study

Silber

Diro

Workneh

et al. 2017

The American Journal of Tropical Medicine and Hygiene

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Abstract.This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a new chewable, rapidly-disintegrating mebendazole (MBZ) 500 mg tablet for Ascaris lumbricoides and Trichuris trichiura infection treatment. Pediatric patients (1–15 years; N = 295; from Ethiopia and Rwanda) excreting A. lumbricoides and/or T. trichiura eggs were enrolled. The study had a screening phase (3 days), a double-blind treatment phase (DBP, 19 days), and an open-label phase (OLP, 7 days). Patients received MBZ or placebo on day 1 of DBP and open-label MBZ on day 19 ± 2 after stool sample collection. Cure rates (primary endpoint), defined as species-specific egg count of 0 at the end of DBP, were significantly higher in the MBZ group than placebo for A. lumbricoides (83.7% [72/86; 95% CI: 74.2%; 90.8%] versus 11.1% [9/81; 95% CI: 5.2%; 20.1%], P < 0.001) and for T. trichiura (33.9% [42/124; 95% CI: 25.6%; 42.9%] versus 7.6% [9/119; 95% CI: 3.5%; 13.9%], P < 0.001). Egg reduction rates (secondary endpoint) were significantly higher in the MBZ group than placebo for A. lumbricoides (97.9% [95% CI: 94.4; 99.9] versus 19.2% [95% CI: −5.9; 41.5]; P < 0.001) and T. trichiura (59.7% [95% CI: 33.9; 78.8] versus 10.5% [95% CI: −16.8; 32.9]; P = 0.003). Treatment-emergent adverse events (TEAEs) in MBZ group occurred in 6.3% (9/144) of patients during DBP and 2.5% (7/278) during OLP. No deaths, serious TEAEs, or TEAEs leading to discontinuations were reported. A 500 mg chewable MBZ tablet was more efficacious than placebo for the treatment of A. lumbricoides and T. trichiura infections in pediatric patients, and no safety concerns were identified.

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“…MBZ (methyl 5-benzoyl-2-benzimidazole-carbamate) is a broad-spectrum anthelminthic drug introduced to the market in 1972 that is widely used for the treatment of different parasitic infections, mainly helminths. 5 , 15 , 16 , 17 During its more than 40 years of use, the safety of MBZ has repeatedly been demonstrated. Even at the dose used in these trials, AEs were generally moderate, transient, and self-limiting similar to what was also observed in previous MBZ trials conducted in Cuba.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effectiveness and Tolerability of 3-Day Mebendazole Treatment of Giardia duodenalis Infection in Adults and Children: Two Prospective, Open-Label Phase IV Trials

Cañete¹,

Brito

et al. 2018

Current Therapeutic Research

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BackgroundGiardia duodenalis is the most common intestinal pathogenic protozoan infection reported in humans. Both in vitro studies and 4 separate, sequential, comparative clinical trials conducted by our group in Cuba demonstrated mebendazole activity against G. duodenalis infection in both children and adults.ObjectiveThe 2 additional, prospective, open-label, Phase IV follow-up studies reported here were performed to further assess the effectiveness and safety profile of mebendazole in the outpatient treatment of G. duodenalis infection.MethodsAssenting children (n = 522) whose guardians gave permission and consenting adults (n = 423) diagnosed with G. duodenalis infection were given mebendazole (200 mg 3 times daily for 3 days). Medical histories and stool samples were obtained and physical/laboratory examinations were performed pretreatment then repeated on days 3, 5, and 7 after treatment completion. The evaluation of efficacy (ie, cure) was based on parasitologic response to therapy. Participants were considered cured, if no Giardia trophozoites or cysts were found in any of the 3 posttreatment fecal specimens evaluated by direct wet mounts and/or after Ritchie concentration techniques.ResultsNo participant refused to be enrolled and all returned for follow-up examinations. At the end of the treatment, stool samples were negative in 450 out of 522 children (86.2%) and 392 of 423 adults (92.7%). Treatment was well tolerated. In adults, the only adverse effect reported was abdominal pain (6.2%). Side effects reported in children included abdominal pain (5.6%), nausea (2.9%), and vomiting (2.3%). Reported side effects were all mild, transient, and self-limited and did not require discontinuation of treatment or additional medication.ConclusionsMebendazole may be an effective alternative treatment of G. duodenalis infections in both children and adults.

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Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12–24 Months of Age

Cited by 8 publications

References 14 publications

Risk of adverse swallowing events and choking during deworming for preschool-aged children

Risk of adverse swallowing events and choking during deworming for preschool-aged children

Efficacy and Safety of a Single-Dose Mebendazole 500 mg Chewable, Rapidly-Disintegrating Tablet for Ascaris lumbricoides and Trichuris trichiura Infection Treatment in Pediatric Patients: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study

Effectiveness and Tolerability of 3-Day Mebendazole Treatment of Giardia duodenalis Infection in Adults and Children: Two Prospective, Open-Label Phase IV Trials

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