Efficacy and Safety of Praziquantel for Treatment of Schistosoma mansoni Infection among School Children in Tanzania

Single-dose targeted praziquantel preventive chemotherapy is the WHO-recommended intervention for schistosomiasis control in endemic countries. The objective of this study was to assess the efficacy and safety of single-dose praziquantel among Schistosoma mansoni-infected children in north-western Tanzania. A prospective safety and efficacy surveillance study was conducted among 341 school-going children treated with a single-dose praziquantel 40 mg/kg body weight. Socio-demographic, pre-treatment, and post-treatment stool examination and safety data were collected. The primary and secondary outcomes were treatment efficacy (parasitological cure and egg reduction rates at three weeks post-treatment) and treatment-related adverse events, respectively. The overall cure rate and egg reduction rate were 81.2% (76.8–85.3%) and 95.0% (92.7–97.3%), respectively. There was no significant association between cure rate and pre-treatment infection intensity. The incidence of treatment-associated adverse events was 28.5% (23.7–33.3%), with abdominal pain being the most common. Post-treatment abdominal pain and vomiting were significantly associated with pre-treatment infection intensity (p < 0.001) and anemia (p = 0.03), respectively. Praziquantel single-dose is still safe and efficacious against Schistosoma mansoni infection. However, the lack of cure in about one-fifth and adverse events in a quarter, of the infected children indicate the need for close praziquantel safety monitoring and treatment optimization research to improve efficacy.

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Efficacy and safety of cumaru syrup as complementary therapy in mild persistent asthma: a double-blind, randomized, placebo-controlled study

Brazilian Journal of Pharmaceutical Sciences ◽

10.1590/s1984-82502012000400006 ◽

2012 ◽

Vol 48 (4) ◽

pp. 629-637

Author(s):

Elisete Mendes Carvalho ◽

Gilmara Holanda da Cunha ◽

Francisco Vagnaldo Fechine ◽

Célia Regina Amaral Uchôa ◽

Manoel Odorico de Moraes Filho ◽

...

Keyword(s):

Placebo Group ◽

Adverse Events ◽

Persistent Asthma ◽

Complementary Therapy ◽

Post Treatment ◽

Controlled Study ◽

Efficacy And Safety ◽

Double Blind ◽

Pre Treatment ◽

Mild Persistent Asthma

Amburana cearensis is a medicinal plant known as "cumaru". It is used in Northeast Brazil in the treatment of respiratory diseases. This was a randomized, double-blind, placebo-controlled study, with the aim of evaluating the efficacy and safety of cumaru syrup as complementary therapy in mild persistent asthma. The study consisted of 3 phases, pre-treatment, treatment and post-treatment. The primary efficacy outcome was comparison of the changes reported by patients of the cumaru and placebo groups after treatment, using the "Asthma Quality of Life Questionnaire" (AQLQ). The secondary outcome was the effect of cumaru syrup on lung function based on spirometry. The results showed that in the cumaru group, the proportion of patients who had global improvement in asthma symptoms was significantly greater (61.90%, P=0.0009) than in the placebo group (9.52%). Only the spirometric parameters Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) showed significant intergroup differences in post-treatment (P<0.05). The hematological and serum chemistry tests performed in the pre-treatment and post-treatment showed no statistically significant differences (P>0.05). Adverse events were reported by 3 patients (14.29%) in the cumaru group and 3 patients (14.29%) in the placebo group. All adverse events were considered non-serious and mild.

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

10.21203/rs.2.19725/v2 ◽

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

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Single-Blind, Prospective, Randomized Study of Cefmetazole and Cefoxitin in the Treatment of Postcesarean Endometritis

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/s1064744995000263 ◽

1995 ◽

Vol 3 (1) ◽

pp. 28-33 ◽

Cited By ~ 4

Author(s):

Ashwin Chatwani ◽

Mark Martens ◽

David A. Grimes ◽

Molly Chatterjee ◽

Melvin Noah ◽

...

Keyword(s):

Side Effects ◽

Adverse Events ◽

Cesarean Delivery ◽

Clinical Efficacy ◽

Randomized Study ◽

Prospective Randomized Study ◽

Efficacy And Safety ◽

Cure Rate ◽

Clinical Responses ◽

Single Blind

Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery.Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g IV q 6 h in a 2:1 ratio. The patients were followed for clinical responses and side effects.Results: The cure rate for cefmetazole was 89% and for cefoxitin it was 79% (P = 0.006). The adverse events were similar in both groups.Conclusions: Cefmetazole was significantly more effective than cefoxitin in the treatment of endometritis following cesarean delivery.

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Efficacy of Mebendazole and Praziquantel against Soil-Transmitted Helminths and Schistosoma mansoni Infections among Schoolchildren in Northwest Ethiopia

BioMed Research International ◽

10.1155/2021/6682418 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Kefale Ejigu ◽

Tadesse Hailu ◽

Megbaru Alemu

Keyword(s):

Single Dose ◽

Schistosoma Mansoni ◽

Reduction Rate ◽

Northwest Ethiopia ◽

Cure Rate ◽

Soil Transmitted Helminths ◽

Stool Samples ◽

Periodic Evaluation ◽

The Tropics ◽

Egg Reduction Rate

Background. Soil-transmitted helminths (STHs) and Schistosoma mansoni are the main causes of morbidity among schoolchildren in the tropics. A school-based deworming program was launched to control and eliminate the infection in endemic countries including Ethiopia. Although periodic deworming is conducted in endemic areas, the prevalence of the infection is high in the country. In addition, periodic evaluation of the efficacy of the anthelminthic drug is limited. Objective. This study is aimed at checking the efficacy of mebendazole and praziquantel with the respective STHs and Schistosoma mansoni parasites. Methods. A longitudinal study was conducted from February to March 2018 among 422 schoolchildren. Stool samples were collected at baseline and at 2 and 4 weeks posttreatment and were processed using the Kato-Katz technique. Schoolchildren positive for STHs were treated with mebendazole and those positive for Schistosoma mansoni with praziquantel. After two weeks, a second round of stool was collected and examined, and then, single-dose redosing was given to each positive child. Lastly, the third stool sample was collected two weeks after the initiation of the redosing and checked for STHs and S. mansoni parasites. A close follow-up of students who were treated was done. All the data were entered and analyzed using SPSS version 20 for analysis. Descriptive statistics was used to compute the cure rate and egg reduction rate of mebendazole and praziquantel. Results. Among 422 participants, the prevalence of STHs, hookworm, Ascaris lumbricoides, and S. mansoni was 44.7%, 35.1%, 21.1%, and 13.9%, respectively. The cure rate of mebendazole against A. lumbricoides increased from 60% in the single dose to 100% in redosing after two weeks. The cure rate of mebendazole against hookworm also increased from 32.4% in the single dose to 91.0% in the redosing. The cure rate of praziquantel against S. mansoni-infected children was 91.5% in the first round and 100% in the redosing phase. There was a 98.6-100% egg reduction rate in the redosing regimen of both drugs. Conclusion. The cure and egg reduction rates of single-dose mebendazole in the treatment of hookworm and A. lumbricoides are lower at week two than at redosing, while cure and egg reduction rates of single-dose praziquantel are satisfactory to treat S. mansoni. Therefore, single-dose praziquantel to S. mansoni and redosing of single-dose mebendazole to A. lumbricoides and hookworm infections can be used for treatment purposes.

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Is Oral Sulfate Tablet Effective and Safe for Bowel Preparation Before Colonoscopy in Elderly People 65 Years of Age and Older?

10.21203/rs.3.rs-798500/v1 ◽

2021 ◽

Author(s):

Jae Hyun Kim ◽

Yong Eun Park ◽

Tae Oh Kim ◽

Jongha Park ◽

Won Moon ◽

...

Keyword(s):

Abdominal Pain ◽

Polyethylene Glycol ◽

Adverse Events ◽

Elderly Patients ◽

Elderly People ◽

Patient Compliance ◽

Bowel Preparation ◽

Abdominal Distension ◽

Efficacy And Safety ◽

Better Than

Abstract Background Recently, a novel oral sulfate tablet (OST) has been introduced for bowel preparation before colonoscopy. However, whether elderly patients can take OST is not yet clear, as OST consists of 28 tablets. We aimed to compare the efficacy and safety of OST and polyethylene glycol (PEG) for bowel preparation for colonoscopy according to age. Method: We randomly divided subjects into a OST group and a PEG group and compared Boston bowel preparation score (BBPS), bubble score, patient compliance and satisfaction, and safety between the two groups according to age (under 65 years of age vs. 65 years of age and older). Results Among the 179 participants, sixty-one were 65 years of age and older. The BBPS and bubble score of the OST group were better than that of the PEG group, regardless of age. The satisfaction of the OST group was better than that the PEG group, regardless of age. The compliance was not different between the two groups, however, the OST group under 65 years of age had a higher rate of completing the dose within 2 h compared with the PEG group under 65 years of age. Adverse events including abdominal distension, abdominal pain, nausea or vomiting were not different between the two groups. Conclusion The use of OST for bowel preparation before colonoscopy is as effective and safe as PEG, and these results were consistent in elderly people 65 years of age and older.

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Efficacy and Safety of Methylnaltrexone for the Treatment of Opioid-Induced Constipation: A Meta-analysis of Randomized Controlled Trials

10.21203/rs.3.rs-100123/v1 ◽

2020 ◽

Author(s):

Ying-Ying Zhang ◽

Rong Zhou ◽

Wan-Jie Gu

Keyword(s):

Abdominal Pain ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Efficacy And Safety ◽

Safety Outcome ◽

Randomized Controlled ◽

Safety Outcomes

Abstract Background: Opioid-induced constipation (OIC) is a distressing side effect during opioid analgesia and is mainly mediated by gastrointestinal μ opioid receptors. Methylnaltrexone, a peripheral μ opioid receptor antagonist with restricted ability to cross the blood-brain barrier, may alleviate OIC without reversing analgesia. We performed a meta-analysis to assess the efficacy and safety of methylnaltrexone for the treatment of OIC.Methods: We searched PubMed, Embase, and Cochrane Library for randomized controlled trials that compared methylnaltrexone with placebo for the treatment of OIC. The primary efficacy outcome was rescue-free bowel movement (RFBM) within 4 hours after the first dose. Secondary efficacy outcomes included RFBM within 24 hours after the first dose, RFBM ≥3 times per week, and need take rescue laxatives. The primary safety outcome was any adverse events. Secondary safety outcomes included abdominal pain, diarrhea, nausea, vomiting, and flatulence. Relative risks (RR) and 95% confidence interval (CI) were pooled using random-effects model with the intention-to-treat principle. We used the GRADE approach to assess the certainty of the evidence.Results: Eight trials with 2,034 participants were included. Compared with placebo, methylnaltrexone significantly increased RFBM within 4 hours after the first dose (8 trials; 1,833 participants; RR 3.74, 95% CI 3.02-4.62; I2 = 0%; high-certainty evidence), RFBM within 24 hours after the first dose (2 trials; 614 participants; RR 1.98, 95% CI 1.52-2.58; I2 = 9%; moderate-certainty evidence), and RFBM ≥3 times per week (3 trials; 1,396 participants; RR 1.33, 95% CI 1.17-1.52; I2 = 0%; moderate-certainty evidence) and decreased need to take rescue laxatives (3 trials; 807 participants; RR 0.73, 95% CI 0.63-0.85; I2 = 0%; moderate-certainty evidence). For safety outcomes, there was no difference in any adverse events between the two groups (8 trials; 2,034 participants; RR 1.11, 95% CI 0.99-1.23; I2 = 34%; moderate-certainty evidence), including diarrhea, nausea, vomiting, and flatulence; but for the most commonly reported adverse events, the abdominal pain was higher in methylnaltrexone group than that in placebo group (6 trials; 1,813 participants; RR 2.30, 95% CI 1.29-4.08; I2 = 62%; moderate-certainty evidence).Conclusions: Methylnaltrexone is an effective and safe drug for treating OIC. But the safety of abdominal pain should be considered.Trial registration: PROSPERO (CRD42020187290).

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A comparative field trial, conducted without pre-treatment census baiting, of the rodenticides zinc phosphide, thallium sulphate and gophacide against Rattus norvegicus

Journal of Hygiene ◽

10.1017/s0022172400055510 ◽

1976 ◽

Vol 77 (1) ◽

pp. 55-62 ◽

Cited By ~ 6

Author(s):

B. D. Rennison

Keyword(s):

Single Dose ◽

Rattus Norvegicus ◽

Field Trial ◽

Zinc Phosphide ◽

Post Treatment ◽

Pre Treatment ◽

Better Than

SUMMARYThe effectiveness of the single-dose poison treatments of farm rat infestations, analysed by comparing the weights of the post-treatment census bait takes in covariance with the weights of the prebait takes, showed that treatments with 2·5% zinc phosphide, 0·3% thallium sulphate or 0·3% gophacide were equally effective and significantly better than were treatments with 1% zinc phosphide or 0·1% thallium sulphate. The methodology and sensitivity of different analyses are also considered.

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Ivermectin Treatment Response in Onchocerca Volvulus Infected Persons with Epilepsy: A Three-Country Short Cohort Study

Pathogens ◽

10.3390/pathogens9080617 ◽

2020 ◽

Vol 9 (8) ◽

pp. 617

Author(s):

Alfred Dusabimana ◽

Dan Bhwana ◽

Stephen Raimon ◽

Bruno P. Mmbando ◽

An Hotterbeekx ◽

...

Keyword(s):

Democratic Republic Of Congo ◽

Geometric Mean ◽

Infection Intensity ◽

Post Treatment ◽

Onchocerca Volvulus ◽

Ivermectin Treatment ◽

Positive Skin ◽

History Of ◽

Pre Treatment ◽

Study Sites

Despite a long history of community-directed treatment with ivermectin (CDTI), a high ongoing Onchocerca volvulus transmission is observed in certain onchocerciasis-endemic regions in Africa with a high prevalence of epilepsy. We investigated factors associated with higher microfilarial (mf) density after ivermectin treatment. Skin snips were obtained from O. volvulus-infected persons with epilepsy before, and 3 to 5 months after ivermectin treatment. Participants were enrolled from 4 study sites: Maridi (South Sudan); Logo and Aketi (Democratic Republic of Congo); and Mahenge (Tanzania). Of the 329 participants, 105 (31.9%) had a post-treatment mf density >20% of the pre-treatment value. The percentage reduction in the geometric mean mf density ranged from 69.0% (5 months after treatment) to 89.4% (3 months after treatment). A higher pre-treatment mf density was associated with increased probability of a positive skin snip after ivermectin treatment (p = 0.016). For participants with persistent microfiladermia during follow-up, a higher number of previous CDTI rounds increased the odds of having a post-treatment mf density >20% of the pre-treatment value (p = 0.006). In conclusion, the high onchocerciasis transmission in the study sites may be due to initially high infection intensity in some individuals. Whether the decreasing effect of ivermectin with increasing years of CDTI results from sub-optimal response mechanisms warrants further research.

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In vivo and in vitro efficacy of a single dose of albendazole against hookworm infection in northwest Ethiopia: open-label trial

Tropical Medicine and Health ◽

10.1186/s41182-021-00308-0 ◽

2021 ◽

Vol 49 (1) ◽

Author(s):

Wolelaw Bezie ◽

Mulugeta Aemero ◽

Yalewayiker Tegegne ◽

Tegegne Eshetu ◽

Ayenew Addisu ◽

...

Keyword(s):

Single Dose ◽

Infection Intensity ◽

Risk Groups ◽

Northwest Ethiopia ◽

Post Treatment ◽

Open Label ◽

Preventive Chemotherapy ◽

Stool Samples

Abstract Background Control of hookworm and other soil-transmitted helminth infections primarily relies on preventive chemotherapy using a single dose of albendazole/mebendazole drugs on high-risk groups. Herein, the efficacy of a single dose (400 mg) of albendazole (ALB) was investigated both in vivo and in vitro model in northwest Ethiopia. Methods An open-label, single-arm clinical trial was conducted to assess anti-hookworm effect of albendazole. Stool samples were collected and examined using McMaster and Harada-Mori filter paper culture. Eligible hookworm-infected patients were treated with a single dose of ALB. After 14–21 days post-treatment, stool samples were also taken again and re-examined using the abovementioned technique. Egg reduction rate (ERR) and larval motility were used as a therapeutic outcome measure. An independent t test was used to compare the mean difference in egg counts, and probit analysis was performed for calculating the lethal concentration dose of albendazole. P value < 0.05 at 95% CI was considered statistically significant. Results A total of 70 participants had completed the drug efficacy study. The efficacy of ALB against hookworm in terms of CR and ERR was 87% and 93%, respectively. Participants who had not eaten one or more hours prior to treatment had higher CR than those who had eaten within 1 h before treatment (97.4% vs 74.2%), while individuals with heavy infection intensity had a lower post-treatment ova clearing rate than those who were with light infection intensity (43% vs 94.6%). The in vitro larvicidal effect of ALB was 63–93% after applying 50–250 μg/ml concentration of ALB solution. The LC50 and LC99 were 152 μg/ml and 573 μg/ml, respectively. Conclusion A single dose of albendazole was found to be effective for treating hookworm infections according to WHO anthelminthic evaluation standard in the study area. Preventive chemotherapy might therefore be extended to risk groups, with proper continuous monitoring of its efficacy to strengthen and keep the ongoing control and prevention measures one step ahead. Trial registration This trial is retrospectively registered with www.pactr.org, number PACTR202010511829332 on October 26, 2020.

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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

Gates Open Research ◽

10.12688/gatesopenres.13299.1 ◽

2021 ◽

Vol 5 ◽

pp. 106

Author(s):

Sophie Welsche ◽

Emmanuel C. Mrimi ◽

Ladina Keller ◽

Eveline Hürlimann ◽

Daniela Hofmann ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Single Dose ◽

Controlled Trial ◽

Quantitative Polymerase Chain Reaction ◽

Drug Combinations ◽

Trichuris Trichiura ◽

Post Treatment ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Valuable Adjunct

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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