Efficacy and tolerability of a 4-month ofloxacin-containing regimen compared to a 6-month regimen in the treatment of patients with superficial lymph node tuberculosis: a randomized trial.

BACKGROUND: Tuberculosis (TB) lymphadenitis is the most common form of extra-pulmonary TB, and the treatment duration is six months. This non-inferiority based randomized clinical trial in South India evaluated the efficacy and safety of a four-month ofloxacin containing regimen in tuberculosis lymphadenitis (TBL) patients. METHODS: New, adult, HIV-negative, microbiologically and or histopathologically confirmed superficial lymph node TB patients were randomized to either four-month oflaxacin containing test regimen [ofloxacin (O), isoniazid (H), rifampicin (R), pyrazinamide (Z) -2RHZO daily/ 2RHO thrice-weekly] or a six-month thrice-weekly control regimen (2HRZ, ethambutol/4RH). The treatment was directly observed. Clinical progress was monitored monthly during and up to 12 months post-treatment, and thereafter every three months up to 24 months. The primary outcome was determined by response at the end of treatment and TB recurrence during the 24 months post-treatment. RESULTS: Of the 302 patients randomized, 298 (98.7%) were eligible for modified intention-to-treat (ITT) analysis and 294 (97%) for per-protocol (PP) analysis. The TB recurrence-free favourable response in the PP analysis was 94.0% (95% CI: 90.1-97.8) and 94.5% (95% CI: 90.8-98.2) in the test and control regimen respectively, while in the ITT analysis, it was 92.7% and 93.2%. The TB recurrence-free favourable response in the test regimen was non-inferior to the control regimen 0.5% (95% CI: -4.8-5.9) in the PP analysis based on the 6% non-inferiority margin. Treatment was modified for drug toxicity in two patients in the test regimen, while one patient had a paradoxical reaction. CONCLUSION: The 4-month ofloxacin containing regimen was found to be non-inferior and as safe as the 6-month thrice-weekly control regimen.

Hepatitis autoinmune inducida por levofloxacino. Descripción de un caso / Levofloxacin-induced autoimmune hepatitis. Description of a case

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Anaphylaxis to levofloxacin

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Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil / Efeitos adversos das drogas (minociclina, ofloxacina e clofazimina) utilizadas no esquema alternativo para pacientes com hanseníase multibacilar, em unidade de referência, Manaus, Amazonas, Brasil

BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies ...

FUNDAMENTOS: Após introdução do esquema poliquimioterápico padrão, houve declínio nos coeficientes de prevalência e detecção de casos novos; entretanto, os registros de resistência medicamentosa e recidivas representam ameaça para o controle da hanseníase. Dessa forma, a proposição de novos esquemas alternativos e a necessidade de monitorar efeitos adversos são importantes para evitar o abandono do tratamento. OBJETIVO: Descrever efeitos adversos do esquema alternativo contendo clofazimina, ofloxacina e minociclina em pacientes com hanseníase multibacilar. MÉTODOS: Estudo prospectivo, descritivo e observacional de casos multibacilares, incluindo recidivas ou intolerância à poliquimioterapia padrão, realizado na Fundação Alfredo da Matta, Manaus, Amazonas, de abril de 2010 a janeiro de 2012. Os indivíduos receberam a terapia composta de doses diárias auto-administradas de 100mg de minociclina, 400mg de ofloxacina e 50mg de clofazimina e mensais supervisionadas de 300mg de clofazimina por seis meses, seguidas de 18 meses de doses diárias de ofloxacina 400mg, clofazimina 50 mg e supervisionadas mensais de clofazimina 300mg. Resultados: 21 pacientes foram incluídos. Efeitos adversos leves e transitórios foram observados em 33,3% dos pacientes; 45,9% foram atribuídos à ofloxacina, como dor abdominal, náuseas, vômitos, cefaléia e insônia; 21,6% foram associados à clofazimina, com relatos e observação em 100% dos pacientes de hiperpigmentação cutânea. O tempo médio de desenvolvimento das reações adversas a partir do início do esquema foi de 15,2 dias. ...

Severe shoulder tendinopathy associated with levofloxacin

Fluoroquinolone (FQ)-associated tendinopathy and myopathy are uncommon but well recognized complications of the use of this class of antibacterial agents. The case of a 63-year-old previously asymptomatic female patient who developed severe left shoulder tendinopathy after surreptitiously doubling the prescribed dose of levofloxacin for the treatment of community-acquired pneumonia is reported here. Surgical stabilization with suture anchors and subacromial decompression were needed.

Preditores dos desfechos do tratamento da tuberculose / Predictors of tuberculosis treatment outcomes

OBJETIVO: Analisar os desfechos do tratamento da tuberculose e seus preditores. MÉTODOS: Estudo longitudinal de coorte de pacientes com tuberculose tratados entre 2004 e 2006 no Instituto de Pesquisa Evandro Chagas, na cidade do Rio de Janeiro. As razões de risco ajustadas (RRa) dos preditores foram estimadas. RESULTADOS: Foram incluídos 311 pacientes. As taxas de cura, de abandono, de mortalidade e de falha terapêutica foram, respectivamente, 72 por cento, 19 por cento, 6 por cento e 2 por cento. A troca de regime terapêutico por eventos adversos foi necessária em 8 por cento. O alcoolismo (RRa, 0,30), uso do regime estreptomicina+etambutol+ofloxacina (SEO; RRa, 0,32), infecção por HIV sem tratamento antirretroviral (TARV; RRa, 0,36) e o uso do regime rifampicina+isoniazida+pirazinamida+etambutol (RRa, 0,58) reduziram a probabilidade de cura. A faixa etária mais jovem (RRa, 3,84) e o alcoolismo (RRa, 1,76) aumentaram a probabilidade do abandono. Não foi possível determinar as RRa para os demais desfechos devido a suas baixas prevalências. Entretanto, medidas do risco relativo (RR) identificaram os seguintes potenciais preditores do óbito: uso de esquema SEO (RR, 11,43), infecção pelo HIV sem TARV (RR, 9,64), forma clínica disseminada (RR, 9,09), ausência de confirmação bacteriológica (RR, 4,00), diabetes mellitus (RR, 3,94) e comportamento homo/bissexual (RR, 2,97). A baixa renda (RR, 11,70) foi potencial preditor para falha terapêutica, ao passo que infecção pelo HIV com uso de TARV (RR, 2,46) e forma clínica disseminada (RR, 3,57) foram potenciais preditores para troca do esquema por evento adverso. CONCLUSÕES: O esquema SEO deve ser utilizado transitoriamente quando possível. Os dados confirmam a importância de TARV e sugerem a necessidade de seu início precoce.

OBJECTIVE: To analyze tuberculosis treatment outcomes and their predictors. METHODS: This was a retrospective longitudinal cohort study involving tuberculosis patients treated between 2004 and 2006 at the Instituto de Pesquisa Evandro Chagas, in the city of Rio de Janeiro. We estimated adjusted risk ratios (ARRs) for the predictors of treatment outcomes. RESULTS: Among 311 patients evaluated, the rates of cure, treatment abandonment, treatment failure, and mortality were 72 percent, 19 percent, 2 percent, and 6 percent, respectively. Changes in the treatment regimen due to adverse events occurred in 8 percent. The factors found to reduce the probability of cure were alcoholism (ARR, 0.30), use of the streptomycin+ethambutol+ofloxacin (SEO) regimen (ARR, 0.32), HIV infection without the use of antiretroviral therapy (ART; ARR, 0.36), and use of the rifampin+isoniazid+pyrazinamide+ethambutol regimen (ARR, 0.58). Being younger and being alcoholic both increased the probability of abandonment (ARR, 3.84 and 1.76, respectively). It was impossible to determine the ARR for the remaining outcomes due to their low prevalence. However, using the relative risk (RR), we identified the following potential predictors of mortality: use of the SEO regimen (RR, 11.43); HIV infection without ART (RR, 9.64); disseminated tuberculosis (RR, 9.09); lack of bacteriological confirmation (RR, 4.00); diabetes mellitus (RR, 3.94); and homosexual/bisexual behavior (RR, 2.97). Low income was a potential predictor of treatment failure (RR, 11.70), whereas disseminated tuberculosis and HIV infection with ART were potential predictors of changes in the regimen due to adverse events (RR, 3.57 and 2.46, respectively). CONCLUSIONS: The SEO regimen should not be used for extended periods. The data confirm the importance of ART and suggest the need to use it early.

Retrospective Comparison of Levofloxacin and Moxifloxacin on Multidrug-Resistant Tuberculosis Treatment Outcomes

BACKGROUND/AIMS: To compare the effect of levofloxacin and moxifloxacin on treatment outcomes among patients with multidrug-resistant tuberculosis (MDR-TB). METHODS: A retrospective analysis of 171 patients with MDR-TB receiving either levofloxacin or moxifloxacin was performed. Treatment responses were categorized into treatment success (cured and treatment completed) or adverse treatment outcome (death, failure, and relapsed). RESULTS: The median age of the patients was 42.0 years. Approximately 56% of the patients were male. Seventeen patients had extensively drug-resistant tuberculosis, and 20 had a surgical resection. A total of 123 patients (71.9%) received levofloxacin for a median 594 days, and 48 patients (28.1%) received moxifloxacin for a median 673 days. Other baseline demographic, clinical, and radiographic characteristics were similar between the two groups. The moxifloxacin group had a significantly higher number of resistant drugs (p < 0.001) and a higher incidence of resistance to ofloxacin (p = 0.005) in the drug sensitivity test. The treatment success rate was 78.9% in the levofloxacin group and 83.3% in the moxifloxacin group (p = 0.42). Adverse reactions occurred at similar rates in the groups (p = 0.44). Patients in the moxifloxacin group were not more likely to have treatment success than those in the levofloxacin group (adjusted odds ratio, 0.76; 95% confidence interval, 0.24 to 2.43; p = 0.65). CONCLUSIONS: Both levofloxacin and moxifloxacin showed equivalent efficacy for treating MDR-TB.

Cuidados enfermeros en paciente geriátrico con síndrome de Stevens-Johnson relacionado con levofloxacino: a propósitode un caso / Nursing care in elderly with Stevens-Johnson Syndrome related to levofloxacin: case approach

El Síndrome de Stevens-Johnson (SSJ) es una enfermedad dermatológica rara con afectación mucocutánea y sistémica, siendo la forma más grave de eritema exudativo multiforme y presentándose como una variante de la necrólisis epidérmica tóxica relacionado con etiologíamúltiple. Presentamos el caso de una paciente geriátrica de 84 años de edad, presentado SSJ relacionado con la toma de levofloxacino. La complejidad de cuidados que requirió en una unidad de hospitalización, así como la escasez de referentes bibliográficos en nuestro medio nos conllevaron a elaborar este plan de cuidados enfermeros (AU)

Stevens-Johnson Syndrome (SJS) is a rare dermatological disease with mucocutaneous and systemic involvement,with the mose severe forme of SJS, presenting as a variant of toxic epidermal necrolysis related to a multiple etiology.We report a case of geriatric patient 84 years of age present the syndrome associated with taking levofloxacin. The complexity of care require in an inpatient unit, and the paucity of references in our environment led us to develop this plan of nursing (AU)

Rotura bilateral del tendón Aquiles secundario a levofloxacino / Bilateral achilles’ tendon rupture secondary to levofloxacin

Introducción. Las fluoroquinolonas presentan una variedad de efectos secundarios que incluyen la fototoxicidad, las alteraciones dermatológicas y las tendinopatías. Éstas últimas son más frecuentes en tendones que han tenido gran estrés, como el Aquiles, pero su afección bilateral es muy infrecuente. Caso. Presentamos el caso de una paciente de 83 años que al segundo día de tratamiento con levofloxacino comienza con dolor en ambos tendones de Aquiles, que en la valoración clínica y radiológica al mes de iniciados los síntomas se aprecia rotura de ambos tendones, y requiere de tratamiento quirúrgico mediante tenorrafia y colgajos de fascia de gemelos con buena evolución posterior. Conclusiones. Se realiza una revisión de la bibliografía (AU)

Introduction. Fluoroquinolones possess several side effects including phototoxicity, skin alterations and tendinopathies. The latter are more frequent in tendons subjected to heavy stresses such as the Achilles’ tendon. However, bilateral involvement is rare.Clinical case. We present the case of an 83-year-old patient who, 2 days after beginning treatment with levofloxacin developed pain in both Achilles’ tendons. A clinical-radiological assessment one month after the onset of symptoms revealed rupture of both tendons, which made surgical treatment necessary. A tenorrhaphy was performed with gastrocnemius fascial flaps. The patient's evolution was satisfactory. Conclusions. A literature review was performed (AU)

Levofloxacin-Induced Achilles Tendinitis in a Young Adult in the Absence of Predisposing Conditions

Fluoroquinolones (FQs) represent a major class of antimicrobials that have a high potential as therapeutic agents. Although FQs are generally safe for the use as antimicrobials, they may induce tendinopathic complications such as tendinitis and tendon rupture. A number of factors have been suggested to further predispose a patient to such injuries. Hitherto, a few published cases on tendon disorders have implicated levofloxacin, a more recently introduced FQ. Here, we report a patient with levofloxacin-induced Achilles tendinitis, who exhibited no known predisposing factors. A 20-year-old man without any history of disease or medication presented with community-acquired pneumonia. Levofloxacin was administered and 3 days later, he complained of pain in the left Achilles tendon and revealed redness and swelling in the area. On suspecting Achilles tendinitis, levofloxacin treatment was discontinued, and the tendinitis subsequently improved. To our knowledge, this is the first case report on FQ-induced Achilles tendinitis in Korea.

Rotura de tendón aquíleo asociada a levofloxacino / Levofloxacin-related Achilles tendon rupture

El uso de fluorquinolonas y el riesgo asociado de tendinitis aquílea está bien documentado, pero su prescripción en la práctica clínica es común1,2. Presentamos el caso de un paciente con tendinitis aquilea y posterior rotura a los pocos días de haber finalizado el tratamiento con levofloxacino por infección respiratoria. El diagnóstico temprano y la suspensión del tratamiento son fundamentales porque se podría prevenir el riesgo de rotura del tendón3,4 (AU)

The use of fluoroquinolones and the associated risk of Achilles tendinitis is well-documented however this drug is commonly prescribed in clinical practice1,2. We describe a case of Achilles tendinitis and subsequent tendon rupture a few days after taking levofloxacin for a respiratory infection. Early diagnosis and treatment cessation are essential for preventing the risk of tendon rupture3,4 (AU)

Eficacia de una triple terapia con un inhibidor de la bomba de protones, levofloxacino y amoxicilina, como primer tratamiento, en la erradicación de Helicobacter pylori / Efficacy of triple therapy with a proton pump inhibitor, levofloxacin, and amoxicillin as first-line treatment to eradicate Helicobacter pylori

Introducción: la triple terapia con un inhibidor de la bomba de protones, claritromicina y amoxicilina (IBP-CA) es el tratamiento de primera elección más utilizado en la erradicación de H. pylori. La eficacia de este tratamiento está disminuyendo en los últimos años y se están valorando otras alternativas terapéuticas. Objetivos:valorar la eficacia, cumplimiento y seguridad de una triple terapia con un IBP, amoxicilina y levofloxacino, sustituyendo a la claritromicina, en la erradicación de H. pylori. Métodos: periodo de estudio: 2007-2008. Se incluyen 135 pacientes (65% mujeres), edad media de 53 años, con síntomas dispépticos e infección por H. pylori, constatada por positividad del test rápido de la ureasa, histología o prueba del aliento con urea-C13. Diagnósticos: dispepsia no investigada: 48,9%, dispepsia funcional: 36,3% y dispepsia ulcerosa: 14,8%. Se indica tratamiento con un inhibidor de la bomba de protones, a dosis habitual, amoxicilina 1 g y levofloxacino 500 mg (IBP-LA), administrados de forma conjunta en desayuno y cena, durante 10 días. Se valora el cumplimiento de la triple terapia y sus efectos adversos mediante interrogatorio y su eficacia mediante la negatividad de la prueba del aliento con urea-C13 practicada a las 6-8 semanas del término del tratamiento. Se compara la eficacia, por protocolo, del tratamiento con IBP-LA con la observada en un grupo control de 270 pacientes tratados con IBP-CA durante 10 días en los años 2006-2007. Resultados: 130/135 pacientes (96,2) del grupo de estudio completaron el tratamiento y el protocolo del seguimiento. La eficacia por intención de tratar fue del 71,8% (97/135) y por protocolo del 74,6% (97/130). Dieciséis pacientes (11,8%) presentaron efectos adversos bien tolerados, excepto en 5 pacientes (3.7%) que motivan el abandono del tratamiento. El tratamiento con IBP-CA resultó eficaz, por protocolo, en 204/270 (75,5%) pacientes del grupo control...(AU)

Background: triple therapy including a proton pump inhibitor, clarithromycin, and amoxicillin (PPI-CA) is the first-choice treatment used for H. pylori eradication. The efficacy of this treatment is declining of late, and alternative therapies are currently under evaluation. Objectives: to evaluate the efficacy, safety and compliance of a triple therapy with a PPI, amoxicillin and levofloxacin (PPI-LA) - replacing clarithromycin - for the eradication of H. pylori. Methods: the study included 135 patients (65% women), mean age 53 years, with dyspeptic symptoms and H. pylori infection proven by a positive urease rapid test, histological analysis, or C13-urea breath test. Diagnosis: non-investigated dyspepsia 48.9%, functional dyspepsia 36.3%, and ulcerative dyspepsia 14.8%. Treatment was indicated with a proton pump inhibitor at usual doses, amoxicillin 1 g, and levofloxacin 500 mg, administered jointly during breakfast and dinner for 10 days. We studied the performance of this triple therapy and its effects using a questionnaire, and effectiveness by the negativity of the C13-urea breath test after 6-8 weeks after treatment discontinuation. Per protocol, we compared the effectiveness of PPI-LA with a control group of 270 patients treated with PPI-CA for 10 days. Results: 130 patients (96.2%) could complete the treatment and follow-up protocol. Effectiveness (intention to treat) was 71.8% (97/135) and 74.6% (per protocol) (97/130). Sixteen patients (11.8%) had well-tolerated adverse effects, except for 5 subjects (3.7%) who dropped out. PPI-CA was effective (per protocol) in 204 patients out of 270 (75.5%) in the control group...(AU)

Pancreatitis aguda asociada a levofloxacino / Acute pancreatitis associated with levofloxacin

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Nefromegalia por levofloxacino / No disponible

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Levofloxacino en el tratamiento de infecciones nosocomiales en pacientes críticos / Levofloxacin in the treatment of nosocomial infection in critically ill patients

Introducción. El levofloxacino (LVX) es uno de los antibióticosmás utilizados en pacientes críticos ingresados enServicios o Unidades de Cuidados Intensivos (UCI) españolas.Su utilización en infecciones comunitarias está ampliamentedocumentada, mientras que su uso en infecciones nosocomiales(IN) es menos frecuente y conocido.Objetivo. Describir las indicaciones y formas de empleode LVX en el tratamiento de IN en pacientes ingresados enUCI españolas.Material y método. Estudio abierto, retrospectivo, observacionaly multicéntrico. Se han incluido todos los pacientesingresados en UCI que en los años 2004-2005 recibieron LVXpara el tratamiento de IN. Se ha cumplimentado un cuadernode recogida de datos (CRD) que incluye variables demográficas,de la infección, del tratamiento y de la evolución del proceso infeccioso y del paciente. Se describe la utilizaciónde LVX dependiendo de la IN. Se realiza análisis de regresión logística para identificar las variables relacionadas con respuesta satisfactoria. Los resultados se expresan mediante laodds ratio (OR) y el intervalo de confianza (IC) del 95%.Resultados. Se han incluido 949 pacientes en 87 UCIque han recibido LVX para el tratamiento de 1.103 IN: 460(41,7%) neumonías no relacionadas con ventilación mecánica,256 (23,2%) neumonías relacionadas con ventilación mecánica,107 (9,7%) bacteriemias primarias o relacionadas con catéteresvasculares, 47 (4,3%) infecciones urinarias relacionadascon sonda uretral, 42 (3,8%) infecciones quirúrgicas profundaso de órgano-espacio y 191 (17,3 %) otras infecciones.APACHE II al ingreso de 19,6 (desviación estándar [DE]: 8) yrespuesta sistémica de sepsis grave o shock séptico en el 50,4% de los casos. En 776 (82,7%) ocasiones se ha iniciado el tratamiento de forma empírica y en 589 (62,1%) casos la dosisde elección ha sido de 0,5 g/12 h, con una duración media de 9 días (AU)

Introduction. Levofloxacin (LVX) is one of the most frequentlyused antibiotics in critical patients admitted to SpanishIntensive Care Units (ICU). Their use in communityacquiredinfections has been widely documented, while it is less frequent and known in nosocomial infections (NI).Objective. To describe the indications and utilizationpatterns of LVX in the treatment of NI in patients admittedto Spanish ICU.Material and methods. Open-label, retrospective, observational and multicenter study. All patients admittedto ICU and who were being treated for NI with LVX in the years 2004-2005 were included. A case reportform (CRF) was drawn up and included demographic, infection, treatment, infectious process and patient development variables. NI-dependent LVX usage was described.A logistical regression analysis was carried out in order to identify the variables associated with a satisfactoryresponse. Results are expressed by means of the odds ratio and a 95% confidence interval.Results. A total of 949 patients who were given LVXfor the treatment of 1,103 NI were recruited in 87 ICU:460 (41.7%) with non-mechanical ventilation associatedpneumonia, 256 (23.2 %) mechanical-ventilation associatedpneumonia, 107 (9.7 %) with primary or vascularcatheter-related bacteremia, 47 (4.3 %) with urethral catheter-related urinary infections, 42 (3.8%) with organspaceor deep surgical infections and 191 (17.3%) whohad other types of infection. An APACHE II upon admissionof 19.6 (SD: 8) and severe sepsis or septic shocksystemic response in 50.4% of all cases. On 776 (82.7%)occasions treatment was initiated on an empirical basisand in 589 (62.1%) cases the dose of choice was of 0.5 g/12 h, with a mean duration of 9 days (AU)

Trombocitopenia grave inducida por levofloxacino / No disponible

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