Efficacy of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections among School Children: a Randomized Open-label Trial

2020 ◽  
Author(s):  
Tegegne Eshetu ◽  
Mulugeta Aemero ◽  
Ayalew Jejaw
Keyword(s):  
Single Dose ◽  
Dose Regimen ◽  
Multiple Dose ◽  
Open Label ◽  
Preventive Chemotherapy ◽  
Dose Treatment ◽  
School Aged Children ◽  
Multiple Dose Regimen ◽  
Hookworm Infections

Abstract Background: Despite the existence of a population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, hookworm transmission remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study aimed at evaluating the efficacy of single (500mg) versus multiple doses (100mg twice a day during three consecutive days) of mebendazole against hookworm infections among school-aged children. Methods: This randomized open-label clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible hookworm-positive children were allocated (1:1) to either a single or multiple dose treatment arms. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Only laboratory technicians were blinded. The cure and egg reduction rates which were assessed after 14-21 days of treatment were the primary and secondary therapeutic outcome measures against hookworm infections, respectively. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant. Result: 108 children, 54 in each treatment arm had completed baseline data and received allocated treatment. 103 children had completed follow-up data records and included for the final efficacy analysis. Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR=55.125; 95% CI: 11.92-254.9; P < 0.001. The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001. Conclusion: The single dose regimen of mebendazole for the treatment of hookworm infections showed poor cure and egg reduction rates, while the multiple dose revealed satisfactory. Although multiple dose regimen administration is a bit more complex than the single dose, we strongly encourage replacing it with multiple dose regimen during deworming programs in hookworm endemic areas. Trial registration: This trial is registered in www.pactr.org, # PACTR201911466695052.

Efficacy of a Single dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections among School Children: A Randomized Single-Blinded Trial

2020 ◽  
Author(s):  
Tegegne Eshetu ◽  
Mulugeta Aemero ◽  
Ayalew Jejaw
Keyword(s):  
Single Dose ◽  
Dose Regimen ◽  
Multiple Dose ◽  
Reduction Rate ◽  
Infection Intensity ◽  
Cure Rate ◽  
Preventive Chemotherapy ◽  
School Aged Children ◽  
Multiple Dose Regimen ◽  
Hookworm Infections

Abstract Background : Despite the existence of population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, Hookworm disease transmissions remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study evaluated the efficacy of single (500mg) versus multiple doses (100mg twice a day during three consecutive days) of mebendazole against Hookworm infections among school aged children. Methods : This randomized single-blinded clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible Hookworm positive children were allocated (1:1) to either a single or multiple doses treatment arm. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Main outcome measures : The cure rate against Hookworm and egg reduction rate for determining the changes in infection intensity were the main outcome measures after 14-21 days following dosing. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant. Result: 109 children were participated in both treatment arms. Cure rate against Hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with (OR=55.125; 95% CI: 11.92-254.9; P < 0.001). The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference (t (101) =5.38; 95% CI 230.95-505.36; P < 0.001). Conclusion : The single dose regimen of mebendazole for the treatment of Hookworm infection showed poor efficacy, while the multiple dose revealed satisfactory efficacy. Moreover, infection intensity reduction was not achieved following single dosing. Therefore, we strongly recommend replacing the single dose mebendazole regimen with multiple dose regimen during deworming program in hookworm endemic areas. Trial registration : This trial is registered in www.pactr.org , # PACTR201911466695052

scholarly journals Efficacy of a Single Dose versus Triple Dose Regimen of Mebendazole against Hookworm Infection among School Children: A Randomized, Single blinded Trial.

2019 ◽  
Author(s):  
Tegegne Eshetu ◽  
Mulugeta Aemero ◽  
Ayalew Jejaw
Keyword(s):  
Single Dose ◽  
Dose Regimen ◽  
Reduction Rate ◽  
Secondary Outcome ◽  
Hookworm Infection ◽  
Cure Rate ◽  
School Aged Children ◽  
Egg Reduction Rate ◽  
Triple Dose

Abstract Background: The current control efforts against soil transmitted helminthic infection focused on reducing morbidity and transmission potential through periodic anthelminthic chemotherapy of single dose of mebendazole and albendazole regimen. Single dose mebendazole is one of extensively applicable drug regimen as a preventive chemotherapy in hookworm endemic areas. However, nowadays, studies reveal single dose treatment regimen has poor and unsatisfactory efficacy status against hookworm infection. We evaluated the efficacy status of single dose (500mg) versus triple dose (100mg) of mebendazole against hookworm infection among school aged children.Methods: This randomized, single-blinded clinical trial took place in a primary school on Burie and Debre Elias towns, Northwest Ethiopia among school-aged children (6-14). Using simple randomization, eligible hookworm positive children were randomly allocated (1:1) to either a single dose or triple dose of mebendazole arm. Stool samples were collected at baseline and follow-up period (14-21 days after treatment) for McMaster analysis. The primary and secondary outcome measures in this study were cure rate (CR) and egg reduction rate (ERR), respectively. Results were displayed using tables and figure. Independent t test was used to compare group means, logistic regression was used to calculate odds ratio (OR), and P-value < 0.05 at 95% CI was considered for statistical significance.Result: 109 children were allocated for each treatment arm and 103 children were completed the drug efficacy follow up study. Cure rate against hookworm was significantly higher in triple dose (96.1%) than in single dose (30.8%) with (OR=55.125; 95% CI: 11.92-254.9; P < 0.001). Egg reduction rate against hookworm infection in triple dose (99.5%) was also significantly higher than single dose (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001.Conclusion: Single dose regimen of mebendazole for the treatment of hookworm infection showed poor efficacy, while triple dose revealed satisfactory efficacy. Therefore, we recommend for giving special emphasis on current deworming program which implemented through single dose mebendazole for hookworm endemic area.

scholarly journals Single Versus Multiple Dose Regimen of Prophylactic Antibiotic in Cesarean Section

2014 ◽  
Vol 8 (2) ◽  
pp. 50-53 ◽  
Author(s):  
K Bhattachan ◽  
GN Baral ◽  
L Gauchan
Keyword(s):  
Single Dose ◽  
Hospital Stay ◽  
Dose Regimen ◽  
Multiple Dose ◽  
Prophylactic Antibiotic ◽  
Cesarean Deliveries ◽  
Cord Clamping ◽  
Group I ◽  
Significant Difference ◽  
Multiple Dose Regimen

Aims: The purpose of this study was to compare the efficacy of single combined dose of Cefotaxime and Metronidazole against conventional regimen of Ampicllin and Metronidazole for five days for the prevention of infectious morbidities in cesarean deliveries. Methods: This study was carried out at Paropakar Maternity and Women’s Hospital, Kathmandu from April to August 2011. Hundred patients, who had cesarean deliveries for various indications, were divided into two groups with fifty on each arm. Patients in group I were treated with intravenous single dose of Cefotaxime and Metronidazole after cord clamping, whereas those patients in group II were treated with Ampicillin and Metronidazole for five days. Efficacy of the treatment was compared in terms of postoperative infectious morbidities, duration of hospital stay and cost of antibiotics. Results: Overall ten cases (10%) had post-operative complications in which eight (8%) had infectious and two (2%) had thrombophlebitis. The infectious morbidities were febrile morbidities in four cases (4%) followed by urinary tract infection in three cases (3%) and wound infection in one case (1%). There was no statistically significant difference among distribution of these morbidities and in the mean duration hospital stay. The cost of single dose regimen was one-eighth of the multiple dose regimens which was statistically significant (p=0.000). Conclusions: Single dose of Cefotaxime and Metronidazole was equally effective as multiple doses of Ampicllin and Metronidazole for five days in prevention of infectious morbidities with benefit of cost.Nepal Journal of Obstetrics and Gynaecology / Vol 8 / No. 2 / Issue 16 / July-Dec, 2013 / 50-53 DOI: http://dx.doi.org/10.3126/njog.v8i2.9771  

scholarly journals Pharmacokinetics of Sativex® in Dogs: Towards a Potential Cannabinoid-Based Therapy for Canine Disorders

Biomolecules ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. 279
Author(s):  
María Fernández-Trapero ◽  
Carmen Pérez-Díaz ◽  
Francisco Espejo-Porras ◽  
Eva de Lago ◽  
Javier Fernández-Ruiz
Keyword(s):  
Veterinary Medicine ◽  
Single Dose ◽  
Multiple Dose ◽  
Plasma Concentrations ◽  
Beagle Dogs ◽  
Blood Samples ◽  
Dose Treatment ◽  
Pathological Conditions ◽  
Sublingual Delivery ◽  
Progressive Accumulation

The phytocannabinoid-based medicine Sativex® is currently marketed for the treatment of spasticity and pain in multiple sclerosis patients and is being investigated for other central and peripheral pathological conditions. It may also serve in Veterinary Medicine for the treatment of domestic animals, in particular for dogs affected by different pathologies, including human-like pathological conditions. With the purpose of assessing different dosing paradigms for using Sativex in Veterinary Medicine, we investigated its pharmacokinetics when administered to naïve dogs via sublingual delivery. In the single dose arm of the study, adult Beagle dogs were treated with 3 consecutive sprays of Sativex, and blood samples were collected at 12 intervals up to 24 h later. In the multiple dose arm of the study, Beagle dogs received 3 sprays daily for 14 days, and blood samples were collected for 24 h post final dose. Blood was used to obtain plasma samples and to determine the levels of cannabidiol (CBD), Δ9-tetrahydrocannabinol (Δ9-THC) and its metabolite 11-hydroxy-Δ9-THC. Maximal plasma concentrations of both Δ9-THC (Cmax = 18.5 ng/mL) and CBD (Cmax = 10.5 ng/mL) were achieved 2 h after administration in the single dose condition and at 1 h in the multiple dose treatment (Δ9-THC: Cmax = 24.5 ng/mL; CBD: Cmax = 15.2 ng/mL). 11-hydroxy-Δ9-THC, which is mainly formed in the liver from Δ9-THC, was almost undetected, which is consistent with the use of sublingual delivery. A potential progressive accumulation of both CBD and Δ9-THC was detected following repeated exposure, with maximum plasma concentrations for both cannabinoids being achieved following multiple dose. Neurological status, body temperature, respiratory rate and some hemodynamic parameters were also recorded in both conditions, but in general, no changes were observed. In conclusion, this study demonstrates that single or multiple dose sublingual administration of Sativex to naïve dogs results in the expected pharmacokinetic profile, with maximal levels of phytocannabinoids detected at 1–2 h and suggested progressive accumulation after the multiple dose treatment.

Dose and schedule selection for the anti-CTLA4 monoclonal antibody ticilimumab in patients (pts) with metastatic melanoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8032-8032 ◽  
Author(s):  
J. Gomez-Navarro ◽  
A. Sharma ◽  
V. Bozon ◽  
C. Bulanhagui ◽  
D. Pavlov ◽  
...  
Keyword(s):  
Single Dose ◽  
Metastatic Melanoma ◽  
Clinical Benefit ◽  
Dose Regimen ◽  
Multiple Dose ◽  
Phase 1 ◽  
Phase 2 ◽  
Phase 1 Trial ◽  
Clinical Dose ◽  
Anti Tumor Activity

8032 Background: Ticilimumab therapy has demonstrated anti-tumor activity in pts with metastatic melanoma. Its indirect, immune-mediated antitumor effects pose unique challenges for dose/regimen selection. Methods: It was our original intention to select the clinical dose/regimen of ticilimumab based on (1) clinical safety and tolerability and (2) attainment of target plasma concentrations derived from pre-clinical work using an ex vivo assay of ticilimumab-induced enhancement of cytotoxic T-cell function. Because numerous pts with metastatic melanoma experienced clinical benefit (i.e., durable objective responses [OR] and/or long-term survival) in early clinical trials of ticilimumab, we are using (1) safety and tolerability and (2) clinical benefit to guide dose/regimen selection. Data for evaluating these criteria come from a single-dose Phase 1 trial (0.01, 0.1, 1, 3, 6, 10 and 15 mg/kg) and an ongoing multiple-dose Phase 1/2 trial in pts with melanoma (Phase 1 portion: 3, 6 and 10 mg/kg Q1M; Phase 2 portion: 10 mg/kg Q1M and 15 mg/kg Q3M). Results: In the single-dose Phase 1 trial, 10 mg/kg was the Protocol-defined MTD but a high rate of clinical benefit was seen in the 15 mg/kg dose cohort (6/6 pts). Because the DLTs seen at 15 mg/kg (Gr 3 diarrhea, Gr 3 rash) were moderate and resolved completely within 3 months of dosing, 15 mg/kg Q3M was proposed as a safe and tolerable dose and is being studied in the Phase 2 portion of the multiple-dose Phase 1/2 trial. The Phase 1 portion of the multiple-dose Phase 1/2 trial revealed that 10 mg/kg is safe and tolerable with monthly dosing so 10 mg/kg Q1M is also being studied in the Phase 2 portion of the trial. At the end of the Simon Optimum-defined Stage 1 of the Phase 2 portion of the ongoing trial, the OR rate (3/18 pts) is the same for both dosing regimens. However, with 15 mg/kg Q3M, Gr 3/4 adverse events were less frequent (6% versus 34%). Conclusions: 15 mg/kg Q3M is proposed as the clinical dose/regimen for ticilimumab in metastatic melanoma. This dose/regimen appears to have anti-tumor activity approximately equal to 10 mg/kg Q1M but it appears to have a superior safety profile. [Table: see text]

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