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Medical research on nitazoxanide
Nitazoxanide to Treat Persistent Clostridium difficile Colitis.
Curr Infect Dis Rep. 2008 May; 10(2): 89-90
Bobak DA
Rev Gastroenterol Peru. 2008 Jan-Mar; 28(1): 30-6
Venero Nazario B
Flatulence is a very common complaint related to functional gastrointestinal disorders. We know functional disorders is the main cause of consultation in gastroenterology offices. We don't know the exact reason of flatulence, but the intestinal fermentative microbiota could be an important etiologic factor. The objective of the study is to evaluate the effectiveness of the Nitazoxanida, on the clinical improvement of the flatulence in a group of patients of ambulatory consultation with respect to another group that receives placebo.The present article, is a controlled randomized clinical study designed to double blind, in whom 120 patients with flatulence criteria participate, of which 60 patients received Nitazoxanida 500mg, every 12 hours by 3 days, and the next 60 patients received placebo every 12 hours by 3 days, after one week were reevaluated, and they were put under a test of perception about clinical improvement (Jerome Frank).The Nitazoxanida group and the placebo group were very similar in age, sex, symptoms to the entrance, presence of anxiety, depression and upheavals of the dream. In the Nitazoxanida group was an average of improvement of 4.02 (75.31%) DS 0.94 and with placebo 2.35 (19.58%) D.S. 0.63. with percentage of 0.001 error. Being the perception of global improvement in the Nitazoxanida group 91.67% and in the placebo group 36.67%. Which is statistically significant. The study conclude that Nitozoxanide group produce a significative improvement in the perception of relief of flatulence in comparison to the placebo group. The study sets out a new therapeutic indication of the active principle Nitazoxanide, in flatulence. We found is a high prevalence of anxiety, depression and of upheavals of the dream in patients with flatulence.
J Antimicrob Chemother. 2008 Jul; 62(1): 72-82
Müller J, Ley S, Felger I, Hemphill A, Müller N
OBJECTIVES: The characterization of differential gene expression in Giardia lamblia WB C6 strain C4 resistant to metronidazole and nitazoxanide using microarray technology and quantitative real-time PCR. METHODS: In a previous study, we created and characterized the G. lamblia WB C6 clone C4 resistant to nitazoxanide and metronidazole. In this study, using a microarray-based approach, we have identified open-reading frames (ORFs) that were differentially expressed in C4 when compared with its wild-type WB C6. Using quantitative real-time PCR, we have validated the expression patterns of some of those ORFs, focusing on chaperones such as heat-shock proteins in wild-type and C4 trophozoites. In order to induce an antigenic shift, trophozoites of both strains were subjected to a cycle of en- and excystation. Expression of selected genes and resistance to nitazoxanide and metronidazole were investigated after this cycle. RESULTS: Forty of a total of 9115 ORFs were found to be up-regulated and 46 to be down-regulated in C4 when compared with wild-type. After a cycle of en- and excystation, resistance of C4 to nitazoxanide and metronidazole was lost. Resistance formation and en-/excystation were correlated with changes in expression of ORFs encoding for major surface antigens such as the variant surface protein TSA417 or AS7 ('antigenic shift'). Moreover, expression patterns of the cytosolic heat-shock protein HSP70 B2, HSP40, and of the previously identified nitazoxanide-binding proteins nitroreductase and protein disulphide isomerase PDI4 were correlated with resistance and loss of resistance after en-/excystation. C4 trophozoites had a higher thermotolerance level than wild-type trophozoites. After en-/excystation, this tolerance was lost. CONCLUSIONS: These results suggest that resistance formation in Giardia to nitazoxanide and metronidazole is correlated with altered expression of genes involved in stress response such as heat-shock proteins.
Current and future treatment modalities for Clostridium difficile-associated disease.
Am J Health Syst Pharm. 2008 Apr 15; 65(8): 705-15
Halsey J
PURPOSE: Current and future treatment modalities for Clostridium difficile-associated disease (CDAD) are reviewed. SUMMARY: C. difficile, an anaerobic, spore-forming, gram-negative rod, is the enteric pathogen most frequently identified in patients with antibiotic-associated, nosocomially acquired diarrhea. Infection can lead to severe gastrointestinal illness which can develop into pseudomembranous colitis. Recent outbreaks in North America involved more virulent C. difficile strains, more severe infections, and more complicated treatment courses. Because of the potential for increased toxin-associated damage due to increased toxin exposure time, CDAD treatment often involves cessation of the inciting antibiotic, C. difficile-targeted antibiotic therapy, electrolyte normalization, fluid replacement, and antimotility agent avoidance. First-line therapy for CDAD is treatment with the antibiotic metronidazole. Vancomycin is often used in more severe cases and for treatment-resistant organisms. Treatment regimens may also include probiotics, bile-acid sequestrants, and, in limited cases, intravenous immunoglobulin (IVIG). Alternative treatments for refractory and persistent CDAD include intracolonic vancomycin, nitazoxanide, rifaximin, IVIG, and probiotics. Several target proteins have been proposed for C. difficile vaccine production, including the flagellar cap protein FliD, flagellin FLiC, a cell wall protein (Cwp) (comprising amino- and carboxyl-terminal domains), a protease Cwp 84, and toxins A and B. Rarely, pseudomembranous colitis, a severe complication of CDAD, must be treated through surgical intervention. CONCLUSION: CDAD is a major concern for health care systems and clinicians. New diagnostic tests with increased sensitivity for detecting CDAD with a short turnaround time are necessary for early treatment and prevention. Continued research for more effective treatments and vaccine development for CDAD is also needed.
Immunochemotherapy for cryptosporidiosis in immunosuppressed mouse model.
J Egypt Soc Parasitol. 2007 Dec; 37(3): 945-56
Sanad MM, Al-Malki JS
Immunochemotherapy as a dual regimen (Nitazoxanide NTZ and Interferon gamma INF-gamma) and a triple one (NTZ, INF-gamma & Paromomycin PRM), administered to immunosuppressed Cryptosporidium infected mice for 10 days (4th-13th day post-infection) was evaluated during and after treatment by determination of parasite count in ileum, associated histopathological changes, oocyst count in Kinyoun's acid fast stained faecal smears, percent reduction in oocyst excretion and cure rate. Both regimens induced nearby efficacy (P > 0.05) with significant reduction in parasite count in the ileum on 7th (P < 0.01) & 14th (P < 0.001) P.I. days, partial regression of histopathological changes and reduction in oocyst count from the 2nd day post-treatment. Oocyst excretion reduction percent was reached zenith on 13th P.I day in both dual (95.76%) and triple (94.86%) regimens (P > 0.05). Complete cure was not achieved. Three days post-treatment relapse occurred in both regimens (P < 0.001) increase in oocyst count (P < 0.01) increase in parasite count in ileum, more severe histopathological changes with rapid deterioration and then, death of all remaining treated mice
Ann Trop Med Parasitol. 2008 Apr; 102(3): 199-207
Escobedo AA, Alvarez G, González ME, Almirall P, Cañete R, Cimerman S, Ruiz A, Pérez R
Giardia lamblia is among the commonest intestinal protozoa world-wide and may cause significant morbidity, especially in children. Although 5-nitroimidazole compounds have formed the mainstay of giardiasis treatment for several years, the increasing number of reports of refractory cases given these and other antigiardial agents has raised concern and led to a search for other compounds. The aim of the present study was to compare the efficacy and safety, in the treatment of children infected with G. lamblia, of nitazoxanide, given at a dose of 7.5 mg/kg twice a day for 3 days, with those of tinidazole, given as a single dose of 50 mg/kg. Overall, 166 children, each proven to be infected with G. lamblia by the microscopical examination of a faecal sample, were included in the open and randomized trial, each being allocated to receive nitazoxanide or tinidazole. The parents of each treated child were asked to collect two faecal samples from the child between 5 and 10 days after the completion of treatment, for the parasitological follow-up. Only if no G. lamblia were found in both post-treatment samples from a child was that child considered cured. Among the 137 children who completed the study (74 given nitazoxanide and 63 given tinidazole), the frequency of parasitological cure following a single dose of tinidazole was significantly higher than that following six doses of nitazoxanide (90.5% v. 78.4%; P
Treatment of Clostridium difficile infection.
Clin Infect Dis. 2008 Jan 15; 46 Suppl 1: S32-42
Gerding DN, Muto CA, Owens RC
Recent outbreaks of Clostridium difficile infection (CDI) in North America have been due to a more virulent, possibly more resistant strain that causes more-severe disease, making prompt recognition of cases and optimal management of infection essential for a successful therapeutic outcome. Treatment algorithms are presented to help guide the management of patients with CDI. Metronidazole has been recommended as initial therapy since the late 1990s and continues to be the first choice for all but seriously ill patients and those with complicated or fulminant infections or multiple recurrences of CDI, for whom vancomycin is recommended. Other options for recurrent CDI, such as probiotics and currently available anion-exchange resins, have limited efficacy and are potentially harmful. Intravenous immunoglobulin may benefit patients with refractory, recurrent, or severe disease, but no controlled data are available. Two antimicrobials available in the United States for other indications, nitazoxanide and rifaximin, have been used successfully for CDI treatment but, like metronidazole, lack United States Food and Drug Administration approval for this indication. Experimental treatments currently in clinical development include a toxin-binding polymer, tolevamer; 2 poorly absorbed antimicrobials, OPT-80 (formerly known as Difimicin) and ramoplanin; monoclonal antibodies; and a C. difficile vaccine.
J Health Econ. 2008 Mar; 27(2): 405-26
Castillo-Riquelme M, Chalabi Z, Lord J, Guhl F, Campbell-Lendrum D, Davies C, Fox-Rushby J
Few cost-effectiveness analysis (CEA) models have accounted for geographic variation in input parameters. This paper describes a deterministic discrete-time multi-state model to estimate the cost-effectiveness of vector control policies for Chagas disease, where implementation varies according to village characteristics. The model outputs include the total number of new infections, disability adjusted life years (DALYs) incurred, costs of associated healthcare, and total costs of the Ministry of Health's control policy for house surveillance and spraying. Incremental net benefits were estimated to determine Colombian villages in which it is cost-effective to implement the control policy. The robustness of these conclusions was evaluated by deterministic sensitivity analyses. The model should help provide a decision-support system to compare control policies and to allocate resources geographically.
Preliminary evidence of nitazoxanide activity on Toxocara canis in a mouse model.
Int J Antimicrob Agents. 2008 Feb; 31(2): 182-4
Delgado OM, Fernandez G, Silva S, Ramirez O, Romero J, Rodriguez-Morales AJ
Arzneimittelforschung. 2007; 57(10): 679-83
Agarwal S, Solomon WD, Gowda KV, Selvan PS, Ghosh D, Sarkar AK, Chattaraj TK, Pal TK
OBJECTIVE: The pharmacokinetics of nitazoxanide (CAS 55981-09-4) and ofloxacin (CAS 82419-36-1) has been extensively evaluated in adult human volunteers individually after oral administration of tablet formulation. However, no published data is available regarding the combined pharmacokinetics and bioavailability of this particular fixed dose combination. In light of the above, a clinical study was designed to evaluate the bioequivalence of two fixed dose combination (FDC) products of two manufacturers containing nitazoxanide 500 mg and ofloxacin 200 mg in healthy Indian male volunteers. METHODS: 24 healthy male volunteers (age 25 +/- 4.6 years; weight 74.5 +/- 7.87 kg) were enrolled in this study. Each subject received a Test fixed dose combination and a Reference fixed dose combination formulation in a randomized, single dose, fasting state, two period, crossover study design with a 1-week washout period between the doses. Extraction of the drugs from the plasma was carried out by precipitation method. Analysis of tizoxanide (active metabolite of nitazoxanide) and ofloxacin from plasma samples was done by a simple and sensitive HPLC method using UV detection developed in our laboratory. An analysis of variance was performed on the pharmacokinetic parameters Cmax, AUC(0-t), AUC(0-infinity). using general linear model (GLM) procedures in which sources of variation were subject, formulation, period. RESULTS: The results of this investigation indicated that there were no statistically significant differences between the two products in either the mean concentration-time profiles or in the obtained pharmacokinetic parameters. 90 % confidence limits for the log-transformed data of Cmax, AUC(0-t), AUC(0-infinity) were within the acceptable range of 0.80-1.25. CONCLUSION: Thus, these findings clearly indicate that the two products are bioequivalent in terms of rate and extent of drug absorption. Both the preparations were well tolerated with no adverse reactions seen throughout the study.