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Early Bactericidal Activity Trial of Nitazoxanide for Pulmonary Tuberculosis.

Revista Antimicrobial agents and chemotherapy
Año 2020
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This study was conducted in treatment-naive adults with drug-susceptible pulmonary tuberculosis in Port-au-Prince, Haiti, to assess the safety, bactericidal activity, and pharmacokinetics of nitazoxanide (NTZ). This was a prospective phase II clinical trial in 30 adults with pulmonary tuberculosis. Twenty participants received 1 g of NTZ orally twice daily for 14 days. A control group of 10 participants received standard therapy over 14 days. The primary outcome was the change in time to culture positivity (TTP) in an automated liquid culture system. The most common adverse events seen in the NTZ group were gastrointestinal complaints and headache. The mean change in TTP in sputum over 14 days in the NTZ group was 3.2 h ± 22.6 h and was not statistically significant (P = 0.56). The mean change in TTP in the standard therapy group was significantly increased, at 134 h ± 45.2 h (P < 0.0001). The mean NTZ MIC for Mycobacterium tuberculosis isolates was 12.3 μg/ml; the mean NTZ maximum concentration (Cmax) in plasma was 10.2 μg/ml. Negligible NTZ levels were measured in sputum. At the doses used, NTZ did not show bactericidal activity against M. tuberculosis Plasma concentrations of NTZ were below the MIC, and its negligible accumulation in pulmonary sites may explain the lack of bactericidal activity. (This study has been registered at ClinicalTrials.gov under identifier NCT02684240.).

Estudio primario

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Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness

Revista Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Año 2019
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BACKGROUND: Effective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness. METHODS: From March 2014 through March 2017, a double-blind, placebo-controlled trial was conducted in 260 participants ≥1 year old hospitalized with influenza-like illness at 6 hospitals in Mexico. Participants were randomized 1:1 to NTZ (age ≥12 years, 600 mg twice daily; age 4–11 years and 1–3 years, 200 or 100 mg twice daily, respectively) or placebo for 5 days in addition to standard of care. The primary endpoint was time from first dose to hospital discharge. Influenza reverse-transcription polymerase chain reaction and Respifinder 22 multiplex test were used for virus detection. RESULTS: Of 260 participants enrolled, 257 were randomized and took at least 1 dose of study treatment (intention-to-treat population): 130 in the NTZ group and 127 in the placebo group. The Kaplan-Meier estimate of the median duration of hospitalization was 6.5 (interquartile range [IQR], 4.0–9.0) days in the NTZ group vs 7.0 (IQR, 4.0–9.0) days in the placebo group (P = .56). Duration of hospitalization between the 2 treatments was similar in children (P = .29) and adults (P = .62), influenza A and B (P = .32), and other respiratory viruses. Seven (5.4%) and 6 (4.7%) participants in the NTZ and placebo groups, respectively, reported serious adverse events. CONCLUSIONS: Treatment with NTZ did not reduce the duration of hospital stay in severe influenza-like illness. Further analyses based on age and evaluations by virus did not reveal any subgroups that appeared to benefit from NTZ. CLINICAL TRIALS REGISTRATION: NCT02057757.

Estudio primario

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Randomized controlled study of a novel triple nitazoxanide (NTZ)-containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection.

Revista Helicobacter
Año 2017
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BACKGROUND: Helicobacter pylori infection has become more and more resistant to conventional first-line treatment regimens. So, there is a considerable interest in evaluating new antibiotic combinations and regimens. Nitazoxanide is an anti-infective drug with demonstrated activity against protozoa and anaerobic bacteria including H. pylori. This work is designed to evaluate the efficacy and safety of a unique triple nitazoxanide-containing regimen as a treatment regimen in Egyptian patients with H. pylori infection. METHODS: Two hundred and 24 patients with upper gastrointestinal tract (GIT) dyspeptic symptoms in whom H. pylori -induced GIT disease was confirmed were included in the study. They have been randomized to receive either nitazoxanide 500 mg b.i.d., clarithromycin 500 mg b.i.d., and omeprazole 40 mg twice daily for 14 days or metronidazole 500 mg b.i.d., clarithromycin 500 mg b.i.d., and omeprazole 40  mg twice daily for 14 days. Laboratory evaluation for H. pylori antigen within the stool was performed 6 weeks after cessation of H. pylori treatment regimens to assess the response. RESULTS: The response to treatment was significantly higher in group 1 of nitazoxanide treatment regimen than group 2 of traditional treatment regimen. One hundred and six cases (94.6%) of 112 patients who completed the study in group 1 showed complete cure, while only 63 cases (60.6%) of 104 patients who completed the study in group 2 showed the same response according to per-protocol (PP) analysis (P<.001). The regimen was well tolerated by all the patients enrolled in the study. CONCLUSION: Nitazoxanide-containing triple therapy is a promising therapy for the first-line eradication of H. pylori. (ClinicalTrials.gov Identifier: NCT02422706).

Estudio primario

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trasplante de microbiota intestinal, un tratamiento simple y eficaz para la infección grave y refractario Clostridium difficile.

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Revista Digestive diseases and sciences
Año 2015
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ANTECEDENTES: La restauración de la flora fecal normales a través del trasplante intestinal microbiota (IMT) fue un éxito en la curación de la infección por Clostridium difficile recurrente (CDI). Sin embargo, sólo se han descrito algunos casos de las IMT siendo utilizado para el tratamiento de CDI severa o fulminante. AIM: ¿Es IMT un tratamiento simple y eficaz para severa y recurrente CDI? MÉTODOS: En este estudio retrospectivo, se reportan 14 pacientes con CDI grave resistente al tratamiento médico convencional, que se sometió a las IMT. muestra de heces frescas de donantes se homogeneizó manualmente con agua caliente del grifo, se filtró a través de una gasa y luego inculcado a través de sonda nasogástrica (SNG). El resultado primario fue la curación clínica, definida como menos de 3 deposiciones sueltas al día en el día 7 después de la TGR y sin necesidad de tratamiento adicional CDI. Los resultados secundarios fueron la recurrencia de CDI dentro de los 100 días de IMT y mortalidad a 30 días después de la TGR. Se realizaron estadísticas descriptivas. RESULTADOS: Catorce pacientes con severa y refractaria CDI recibieron IMT. La edad media fue de 73,4 ± 11,9 años (rango 52-92). IMT se dio a través NGT en 13 de los 14 pacientes. Once pacientes (79%) alcanzaron la curación después de la TGR. No hubo recurrencia se observó en los pacientes que respondieron a las IMT y estaban vivos en el periodo de seguimiento de 100 días. IMT fue bien tolerado. El de 30 días por todas las causas de mortalidad fue del 29%, los 4 pacientes murieron como resultado de su cáncer subyacente. Ninguno de los pacientes murieron como resultado de la CDI o IMT. CONCLUSIONES: IMT lleva a cabo en la cabecera a través de NGT es eficaz y segura para el tratamiento de la severa y refractaria CDI y evita la recurrencia.

Estudio primario

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Evaluation of the BD Max Cdiff assay for the detection of toxigenic Clostridium difficile in human stool specimens.

Revista Pathology
Año 2015
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The Becton Dickinson (BD) PCR-based GeneOhm Cdiff assay has demonstrated a high sensitivity and specificity for detecting Clostridium difficile. Recently, the BD Max platform, using the same principles as BD GeneOhm, has become available in Australia. This study aimed to investigate the sensitivity and specificity of BD Max Cdiff assay for the detection of toxigenic C. difficile in an Australian setting. Between December 2013 and January 2014, 406 stool specimens from 349 patients were analysed with the BD Max Cdiff assay. Direct and enrichment toxigenic culture were performed on bioMérieux ChromID C. difficile agar as a reference method. isolates from specimens with discrepant results were further analysed with an in-house PCR to detect the presence of toxin genes. The overall prevalence of toxigenic C. difficile was 7.2%. Concordance between the BD Max assay and enrichment culture was 98.5%. The sensitivity, specificity, positive predictive value and negative predictive value for the BD Max Cdiff assay were 95.5%, 99.0%, 87.5% and 99.7%, respectively, when compared to direct culture, and 91.7%, 99.0%, 88.0% and 99.4%, respectively, when compared to enrichment culture. The new BD Max Cdiff assay appeared to be an excellent platform for rapid and accurate detection of toxigenic C. difficile.

Estudio primario

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Use of a daily disinfectant cleaner instead of a daily cleaner reduced hospital-acquired infection rates.

Revista American journal of infection control
Año 2015
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BACKGROUND: Documenting effective approaches to eliminate environmental reservoirs and reduce the spread of hospital-acquired infections (HAIs) has been difficult. This was a prospective study to determine if hospital-wide implementation of a disinfectant cleaner in a disposable wipe system to replace a cleaner alone could reduce HAIs over 1 year when housekeeping compliance was ≥80%. METHODS: In this interrupted time series study, a ready-to-use accelerated hydrogen peroxide disinfectant cleaner in a disposable wipe container system (DCW) was used once per day for all high-touch surfaces in patient care rooms (including isolation rooms) to replace a cleaner only. The HAI rates for methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and Clostridium difficile were stratified by housekeeping cleaning compliance (assessed using ultraviolet-visible marker monitoring). RESULTS: When cleaning compliance was ≥80%, there was a significant reduction in cases/10,000 patient days for MRSA (P = .0071), VRE (P < .0001), and C difficile (P = .0005). For any cleaning compliance level there was still a significant reduction in the cases/10,000 patient days for VRE (P = .0358). CONCLUSION: Our study data showed that daily use of the DCW applied to patient care high-touch environmental surfaces with a minimum of 80% cleaning compliance was superior to a cleaner alone because it resulted in significantly reduced rates of HAIs caused by C difficile, MRSA, and VRE.

Estudio primario

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Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection--an observational cohort study.

Revista Alimentary pharmacology & therapeutics
Año 2015
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BACKGROUND: Faecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile infection (rCDI). The finding of suitable donor, donor screening and preparation of faecal transplants are challenging in clinical work. AIM: To develop a practical protocol for preparing frozen transplants and to compare the efficacy of previously frozen and fresh faeces in treating rCDI. METHODS: Two healthy volunteers acted as universal donors for the frozen faecal preparations, which were prepared by suspending faeces into physiological saline, adding glycerol to a final concentration of 10% and storing at -80 °C. We compared the outcomes of patients with rCDI who had undergone FMT at colonoscopy and received infusion of previously prepared, freeze-stored faeces (n = 23) or fresh faeces from individual (n = 15) or universal donors (n = 11) (total n = 49). Clinical failure was defined as persistent or recurrent symptoms with a positive C. difficile toxin stool test, and a need for new therapy. RESULTS: At 12 weeks post-FMT, symptoms were resolved in 22 of 23 patients receiving previously frozen faeces, and in all 11 or 14 of 15 patients receiving fresh faeces from the universal or individual donors respectively (totally 25 of 26; P = ns, success rate 96%). Mild transient fever appeared for two patients receiving frozen faeces, but no other significant side effects were observed. 42 patients were followed up for a year post-FMT and the success rate was 88% in both fresh and frozen faeces groups. CONCLUSIONS: Preparation of frozen transplants simplifies the practical aspects of faecal microbiota transplantation without loss of efficacy or safety.

Estudio primario

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La comparación de Genomera C. difficile y Xpert C. difficile como pruebas confirmatorias en un algoritmo de múltiples etapas para el diagnóstico de la infección por Clostridium difficile.

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Revista Journal of clinical microbiology
Año 2015
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Se compararon dos algoritmos de diagnóstico de varios pasos basado en C. Difficile Quik Chek completa y, como pruebas confirmatorias, Genomera C. difficile y Xpert C. difficile. La sensibilidad, especificidad, valor predictivo positivo y valor predictivo negativo fueron 87,2%, 99,7%, 97,1% y 98,3%, respectivamente, para el algoritmo basado en Genomera y 89.7%, 99.4%, 95.5% y 98.6%, respectivamente , para el algoritmo basado en Xpert. Genomera representa una alternativa a la Xpert como prueba confirmatoria de un algoritmo de múltiples pasos para la infección por Clostridium difficile diagnóstico (CDI).

Estudio primario

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Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection.

Revista Alimentary pharmacology & therapeutics
Año 2015
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BACKGROUND: Faecal microbiota transplantation (FMT) from healthy donors is considered an effective treatment against recurrent Clostridium difficile infection. AIM: To study the effect of FMT via colonoscopy in patients with recurrent C. difficile infection compared to the standard vancomycin regimen. METHODS: In an open-label, randomised clinical trial, we assigned subjects with recurrent C. difficile infection to receive: FMT, short regimen of vancomycin (125 mg four times a day for 3 days), followed by one or more infusions of faeces via colonoscopy; or vancomycin, vancomycin 125 mg four times daily for 10 days, followed by 125-500 mg/day every 2-3 days for at least 3 weeks. The latter treatment did not include performing colonoscopy. The primary end point was the resolution of diarrhoea related to C. difficile infection 10 weeks after the end of treatments. RESULTS: The study was stopped after a 1-year interim analysis. Eighteen of the 20 patients (90%) treated by FMT exhibited resolution of C. difficile-associated diarrhoea. In FMT, five of the seven patients with pseudomembranous colitis reported a resolution of diarrhoea. Resolution of C. difficile infection occurred in 5 of the 19 (26%) patients in vancomycin (P < 0.0001). No significant adverse events were observed in either of the study groups. CONCLUSIONS: Faecal microbiota transplantation using colonoscopy to infuse faeces was significantly more effective than vancomycin regimen for the treatment of recurrent C. difficile infection. The delivery of donor faeces via colonoscopy has the potential to optimise the treatment strategy in patients with pseudomembranous colitis.

Estudio primario

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Diagnosis of Clostridium difficile: real-time PCR detection of toxin genes in faecal samples is more sensitive compared to toxigenic culture.

Revista European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
Año 2015
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The diagnosis of Clostridium difficile infection (CDI) requires the detection of toxigenic C. difficile or its toxins and a clinical assessment. We evaluated the performance of four nucleic acid amplification tests (NAATs) detecting toxigenic C. difficile directly from faeces compared to routine toxigenic culture. In total, 300 faecal samples from Danish hospitalised patients with diarrhoea were included consecutively. Culture was performed in duplicate (routine and 'expanded toxigenic culture': prolonged and/or re-culture) and genotypic toxin profiling by polymerase chain reaction (PCR), PCR ribotyping and toxinotyping (TT) were performed on culture-positive samples. In parallel, the samples were analysed by four NAATs; two targeting tcdA or tcdB (illumigene C. difficile and PCRFast C. difficile A/B) and two multi-target real-time (RT) PCR assays also targeting cdt and tcdC alleles characteristic of epidemic and potentially more virulent PCR ribotypes 027, 066 and 078 (GeneXpert C. difficile/Epi and an 'in-house RT PCR' two-step algorithm). The multi-target assays were significantly more sensitive compared to routine toxigenic culture (p < 0.05) and significantly more robust to inhibition compared to PCRFast (p < 0.001). Duplicate 'expanded toxigenic culture' increased the culture-positive rate by 29% compared to routine culture. The ability of the GeneXpert and in-house assays to correctly classify PCR ribotype 027 was high (>95%), and in-house PCR displayed 100% correct identification of PCR ribotypes 066 and 078. Furthermore, the presence of the PCR enhancer bovine serum albumin (BSA) was found to be related to high sensitivity and low inhibition rate. Rapid laboratory diagnosis of toxigenic C. difficile by RT PCR was accurate.