Drug regulatory agencies (DRA) support prescription of generic products of intravenous antibiotics assuming therapeutic equivalence from pharmaceutical equivalence. Recent reports of deaths associated with generic heparin and metoprolol have raised concerns about the efficacy and safety of DRA-approved drugs. To challenge the assumption that pharmaceutical equivalence predicts therapeutic equivalence, we determined in vitro and in vivo the efficacy of the innovator product and 20 pharmaceutically equivalent generics of gentamicin. The data showed that, while only 1 generic product failed in vitro (MIC = 45.3 vs. 0.7 mg/L, P<0.05), 10 products (including gentamicin reference powder) failed in vivo against E. coli due to significantly inferior efficacy (E_max = 4.81 to 5.32 vs. 5.99 log₁₀ CFU/g, P≤0.043). Although the design lacked power to detect differences in survival after thigh infection with P. aeruginosa, dissemination to vital organs was significantly higher in animals treated with generic gentamicin despite 4 days of maximally effective treatment. Pharmaceutical equivalence does not predict therapeutic equivalence of generic gentamicin. Stricter criteria based on solid experimental evidence should be required before approval for human use.

(1) Background: Few reports of necrotizing pneumonia in patients with COVID-19 have been published. We have observed an elevated incidence at two hospitals in our city, suggesting this complication is not uncommon, and may have been overlooked. (2) Methods: This article presents a retrospective, descriptive cohort study that was undertaken from 22 March 2020 to 15 June 2021 in two tertiary care hospitals in Medellín, Colombia. All adult patients admitted to the intensive care unit (ICU) for respiratory failure related to confirmed COVID-19, on invasive mechanical ventilation (IMV), with imaging or surgical findings documenting necrotizing pneumonia (NP) were included. (3) Results: Of 936 patients with COVID-19 that required IMV, 42 (4.5%) developed NP. Overall mortality was 57% and in-hospital mortality was 71%, occurring 15–79 days after COVID-19 diagnosis. NP was diagnosed at a median of 27 days after COVID-19 symptom onset and 15.5 days after initiation of IMV. Infections were polymicrobial in 52.4% of patients. Klebsiella pneumoniae (57%) and Pseudomonas aeruginosa (33%) were the most common etiologic agents. Pulmonary embolism (PE) was documented in 13 patients overall (31%), and in 50% of patients who underwent an angioCT. Drainage and/or surgical procedures were performed on 19 patients (45.2%) with a 75% mortality rate. (4) Conclusions: In our experience, NP is a relatively common, albeit neglected, complication in mechanically ventilated COVID-19 patients, possibly originating in poorly vascularized areas of lung parenchyma. Associated mortality is high. Although drainage procedures did not seem to favorably impact patient outcomes, diagnosis and treatment were late events in the overall disease course, suggesting that early recognition and timely treatment could have a positive impact on prognosis.

A 26-year-old man (human immunodeficiency virus-positive and not taking highly active antiretroviral treatment [HAART]) presented to the emergency room with 2 months of malaise, 20 kg weight loss, high spiking fevers, generalized lymph nodes, night sweats, dry cough, and chest pain when swallowing. On physical examination, he had multiple cervical lymphadenopathies. Suspecting a systemic opportunistic infection, a contrasted chest computed tomography (CT) was done, showing an esophageal to mediastinum fistulae. Two days after admission, a fluoroscopic contrasted endoscopy was done that showed two esophageal fistulae from scrofula to esophagus and then, to mediastinum. A bronchoalveolar lavage and a cervical lymphadenopathy biopsy were done, both showing multiple acid-fast bacillae, where cultures grew Mycobacterium tuberculosis.

Coinfections by cytomegalovirus and Clostridioides difficile are rare and can be life-threatening, especially in immunosuppressed patients. Their symptoms often overlap, thus generating a great diagnostic challenge, with the need for multiple diagnostic aids. Under certain conditions, combined antiviral treatment, requiring the addition of foscarnet, is necessary to control cytomegalovirus. The latter drug is relatively safe; however, adverse reactions should always be considered for proper management. We present a case of a patient with a history of Burkitt's lymphoma in complete remission, who received chemotherapy in the past, and currently is living with HIV with undetectable viral load and CD4+ count of 141 cells/mm3, who presented with cytomegalovirus coinfection with suspected resistance to ganciclovir and Clostridioides difficile colitis. The patient required treatment with foscarnet and developed a genital ulcer, secondary to this drug, and therefore it was necessary to suspend it.

Introducción: Clostridioides difficile (C. difficile) es la causa más común de diarrea asociada a la atención en salud en adultos. En Medellín, son frecuentes las infecciones asociadas al cuidado de la salud por este microorganismo en hospitales de alta complejidad. Objetivos: Identificar los factores clínicos y epidemiológicos asociados a la infección por C. difficile en un hospital universitario de alto nivel de complejidad de la ciudad de Medellín - Colombia. Métodos: Estudio epidemiológico transversal retrospectivo para determinar la prevalencia y evaluar posibles factores asociados a infección por Clostridioides difficile. Se incluyeron 156 pacientes internados en un hospital de alta complejidad de Medellín entre los años 2016 - 2018 que presentaron deposiciones líquidas con criterios clínicos de infección y a quienes se solicitó estudio de toxina para C. difficile (Immunocard®) con resultado positivo. Resultados: Se encontró una prevalencia general del 50 % y una mortalidad atribuible a infección por C. difficile de 11,5 %. El análisis de razones de prevalencia (RPa) mostró que los factores que incrementaron las posibilidades de la infección fue procedencia de zona urbana (RPa= 3,39; IC95 % 1,03 - 11,15), recibir antibióticos durante más de 22 días (RPa= 1,81; IC95 % = 1,11 - 2,95), antecedente de diabetes (RPa = 1,65; IC95 % = 1,16 - 2,35), neoplasia sólida (RPa = 1,64; IC95 % = 1,11 - 2,41) y hospitalización previa en la institución (RPa = 1,58; IC95 % = 1,13 - 2,21). Conclusión: En este trabajo se evidenciaron asociaciones con infección por C. difficile de factores similares a lo descrito en la literatura como las comorbilidades, exposición a antibióticos y la atención hospitalaria.