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Lesão Miocárdica e Prognóstico em Pacientes Hospitalizados com COVID-19 no Brasil: Resultados do Registro Nacional de COVID-19 COVID19 COVID 19 COVID-1 Brasil COVID1 1 COVID-
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Barbosa, Hannah Cardoso
; Martins, Maria Auxiliadora Parreiras
; Jesus, Jordana Cristina de
; Meira, Karina Cardoso
; Passaglia, Luiz Guilherme
; Sacioto, Manuela Furtado
; Bezerra, Adriana Falangola Benjamin
; Schwarzbold, Alexandre Vargas
; Maurílio, Amanda de Oliveira
; Farace, Barbara Lopes
; Silva, Carla Thais Cândida Alves da
; Cimini, Christiane Corrêa Rodrigues
; Silveira, Daniel Vitorio
; Carazai, Daniela do Reis
; Ponce, Daniela
; Costa, Emanuel Victor Alves
; Manenti, Euler Roberto Fernandes
; Cenci, Evelin Paola de Almeida
; Bartolazzi, Frederico
; Madeira, Glícia Cristina de Castro
; Nascimento, Guilherme Fagundes
; Velloso, Isabela Vasconcellos Pires
; Batista, Joanna d’Arc Lyra
; Morais, Júlia Drumond Parreiras de
; Carvalho, Juliana da Silva Nogueira
; Ruschel, Karen Brasil
; Martins, Karina Paula Medeiros Prado
; Zandoná, Liege Barella
; Menezes, Luanna Silva Monteiro
; Kopittke, Luciane
; Castro, Luís César de
; Nasi, Luiz Antônio
; Floriani, Maiara Anschau
; Souza, Maíra Dias
; Carneiro, Marcelo
; Bicalho, Maria Aparecida Camargos
; Lima, Maria Clara Pontello Barbosa
; Godoy, Mariana Frizzo de
; Guimarães-Júnior, Milton Henriques
; Mendes, Paulo Mascarenhas
; Delfino-Pereira, Polianna
; Ribeiro, Raquel Jaqueline Eder
; Finger, Renan Goulart
; Menezes, Rochele Mosmann
; Francisco, Saionara Cristina
; Araújo, Silvia Ferreira
; Oliveira, Talita Fischer
; Oliveira, Thainara Conceição de
; Polanczyk, Carisi Anne
; Marcolino, Milena Soriano
.
Resumo Fundamento As complicações cardiovasculares da COVID-19 são aspectos importantes da patogênese e do prognóstico da doença. Evidências do papel prognóstico da troponina e da lesão miocárdica em pacientes hospitalizados com COVID-19 na América Latina são ainda escassos. Objetivos Avaliar a lesão miocárdica como preditor independente de mortalidade hospitalar e suporte ventilatório mecânico em pacientes hospitalizados, do registro brasileiro de COVID-19. Métodos Este estudo coorte é um subestudo do registro brasileiro de COVID-19, conduzido em 31 hospitais brasileiros de 17 cidades, de março a setembro de 2020. Os desfechos primários incluíram mortalidade hospitalar e suporte ventilatório mecânico invasivo. Os modelos para os desfechos primários foram estimados por regressão de Poisson com variância robusta, com significância estatística de p<0,05. Resultados Dos 2925 pacientes [idade mediana de 60 anos (48-71), 57,1%], 27,3% apresentaram lesão miocárdica. A proporção de pacientes com comorbidades foi maior nos pacientes com lesão miocárdica [mediana 2 (1-2) vs. 1 (0-20)]. Os pacientes com lesão miocárdica apresentaram maiores valores medianos de peptídeo natriurético cerebral, lactato desidrogenase, creatina fosfoquinase, N-terminal do pró-peptídeo natriurético tipo B e proteína C reativa em comparação a pacientes sem lesão miocárdica. Como fatores independentes, proteína C reativa e contagem de plaquetas foram relacionados com o risco de morte, e neutrófilos e contagem de plaquetas foram relacionados ao risco de suporte ventilatório mecânico invasivo. Os pacientes com níveis elevados de troponina apresentaram um maior risco de morte (RR 2,03, IC95% 1,60-2,58) e suporte ventilatório mecânico (RR 1,87;IC95% 1,57-2,23), em comparação àqueles com níveis de troponina normais. Conclusão Lesão cardíaca foi um preditor independente de mortalidade hospitalar e necessidade de suporte ventilatório mecânico em pacientes hospitalizados com COVID-19. COVID19 COVID 19 COVID-1 doença escassos COVID19. 19. COVID19, 19, 3 cidades 2020 invasivo robusta p005 p 0 05 p<0,05 292 idade 6 4871, 4871 48 71 , (48-71) 57,1%, 571 57,1% 57 57,1%] 273 27 27,3 12 (1-2 vs 020. 020 20 . (0-20)] cerebral desidrogenase fosfoquinase Nterminal N terminal própeptídeo pró independentes RR 203 03 2,03 IC95 IC 1,602,58 160258 1,60 2,58 58 1,60-2,58 1,87IC95% 187IC95 1,87 87 1,87;IC95 1,572,23, 157223 1,57 2,23 23 1,57-2,23) normais COVID1 COVID- 202 p00 p<0,0 29 487 4 7 (48-71 57,1 5 27, (1- 02 (0-20) 2,0 IC9 602 1,602,5 16025 160 1,6 258 2,5 1,60-2,5 87IC95 1,87IC95 187IC9 187 1,8 8 1,87;IC9 572 1,572,23 15722 157 1,5 223 2,2 1,57-2,23 p0 p<0, (48-7 57, (1 (0-20 2, 1,602, 1602 16 1, 25 1,60-2, 87IC9 1,87IC9 187IC 18 1,87;IC 1,572,2 1572 15 22 1,57-2,2 p<0 (48- ( (0-2 1,602 1,60-2 87IC 1,87IC 1,572, 1,57-2, p< (48 (0- 1,60- 1,572 1,57-2 (4 (0 1,57-
Abstract Background Cardiovascular complications of COVID-19 are important aspects of the disease’s pathogenesis and prognosis. Evidence on the prognostic role of troponin and myocardial injury in Latin American hospitalized COVID-19 patients is still scarce. Objectives To evaluate myocardial injury as independent predictor of in-hospital mortality and invasive mechanical ventilation support in hospitalized patients, from the Brazilian COVID-19 Registry. Methods This cohort study is a substudy of the Brazilian COVID-19 Registry, conducted in 31 Brazilian hospitals of 17 cities, March-September 2020. Primary outcomes included in-hospital mortality and invasive mechanical ventilation support. Models for the primary outcomes were estimated by Poisson regression with robust variance, with statistical significance of p<0.05. Results Of 2,925 patients (median age of 60 years [48-71], 57.1% men), 27.3% presented myocardial injury. The proportion of patients with comorbidities was higher among patients with cardiac injury (median 2 [1-2] vs. 1 [0-2]). Patients with myocardial injury had higher median levels of brain natriuretic peptide, lactate dehydrogenase, creatine phosphokinase, N-terminal pro-brain natriuretic peptide, and C-reactive protein than patients without myocardial injury. As independent predictors, C-reactive protein and platelet counts were related to the risk of death, and neutrophils and platelet counts were related to the risk of invasive mechanical ventilation support. Patients with high troponin levels presented a higher risk of death (RR 2.03, 95% CI 1.60-2.58) and invasive mechanical ventilation support (RR 1.87, 95% CI 1.57-2.23), when compared to those with normal troponin levels. Conclusion Cardiac injury was an independent predictor of in-hospital mortality and the need for invasive mechanical ventilation support in hospitalized COVID-19 patients. COVID19 COVID 19 COVID-1 diseases disease s prognosis scarce inhospital hospital Registry 3 cities MarchSeptember March September 2020 variance p005 p 0 05 p<0.05 2925 925 2,92 6 4871, 4871 48 71 , [48-71] 571 57 57.1 men, men men) 273 27 27.3 12 [1-2 vs 02. 02 . [0-2]) peptide dehydrogenase phosphokinase Nterminal N terminal probrain pro Creactive C reactive predictors RR 203 03 2.03 95 1.602.58 160258 1.60 2.58 58 1.60-2.58 187 87 1.87 1.572.23, 157223 1.57 2.23 23 1.57-2.23) COVID1 COVID- 202 p00 p<0.0 292 92 2,9 487 4 7 [48-71 5 57. 27. [1- [0-2] 20 2.0 9 602 1.602.5 16025 160 1.6 258 2.5 1.60-2.5 18 8 1.8 572 1.572.23 15722 157 1.5 223 2.2 1.57-2.23 p0 p<0. 29 2, [48-7 [1 [0-2 2. 1.602. 1602 16 1. 25 1.60-2. 1.572.2 1572 15 22 1.57-2.2 p<0 [48- [ [0- 1.602 1.60-2 1.572. 1.57-2. p< [48 [0 1.60- 1.572 1.57-2 [4 1.57-
2.
COVID-19 outcomes in people living with HIV: Peering through the waves COVID19 COVID 19 COVID-1 HIV COVID1 1 COVID-
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Sales, Thaís Lorenna Souza
; Souza-Silva, Maíra Viana Rego
; Delfino-Pereira, Polianna
; Neves, João Victor Baroni
; Sacioto, Manuela Furtado
; Assis, Vivian Costa Morais de
; Duani, Helena
; Oliveira, Neimy Ramos de
; Sampaio, Natália da Cunha Severino
; Ramos, Lucas Emanuel Ferreira
; Schwarzbold, Alexandre Vargas
; Jorge, Alzira de Oliveira
; Scotton, Ana Luiza Bahia Alves
; Castro, Bruno Mateus de
; Silva, Carla Thais Cândida Alves da
; Ramos, Carolina Marques
; Anschau, Fernando
; Botoni, Fernando Antonio
; Grizende, Genna Maira Santos
; Nascimento, Guilherme Fagundes
; Ruschel, Karen Brasil
; Menezes, Luanna Silva Monteiro
; Castro, Luís César de
; Nasi, Luiz Antônio
; Carneiro, Marcelo
; Godoy, Mariana Frizzo de
; Nogueira, Matheus Carvalho Alves
; Guimarães Júnior, Milton Henriques
; Ziegelmann, Patricia Klarmann
; Almeida, Rafaela Charão de
; Francisco, Saionara Cristina
; Silveira Neto, Sidney Teodoro
; Araújo, Silvia Ferreira
; Avelino-Silva, Thiago Junqueira
; Aliberti, Márlon Juliano Romero
; Pires, Magda Carvalho
; Silva, Eduardo Sérgio da
; Marcolino, Milena Soriano
.
Abstract Objective To evaluate clinical characteristics and outcomes of COVID-19 patients infected with HIV, and to compare with a paired sample without HIV infection. Methods This is a substudy of a Brazilian multicentric cohort that comprised two periods (2020 and 2021). Data was obtained through the retrospective review of medical records. Primary outcomes were admission to the intensive care unit, invasive mechanical ventilation, and death. Patients with HIV and controls were matched for age, sex, number of comorbidities, and hospital of origin using the technique of propensity score matching (up to 4:1). They were compared using the Chi-Square or Fisher's Exact tests for categorical variables and the Wilcoxon for numerical variables. Results Throughout the study, 17,101 COVID-19 patients were hospitalized, and 130 (0.76%) of those were infected with HIV. The median age was 54 (IQR: 43.0;64.0) years in 2020 and 53 (IQR: 46.0;63.5) years in 2021, with a predominance of females in both periods. People Living with HIV (PLHIV) and their controls showed similar prevalence for admission to the ICU and invasive mechanical ventilation requirement in the two periods, with no significant differences. In 2020, in-hospital mortality was higher in the PLHIV compared to the controls (27.9% vs. 17.7%; p = 0.049), but there was no difference in mortality between groups in 2021 (25.0% vs. 25.1%; p > 0.999). Conclusions Our results reiterate that PLHIV were at higher risk of COVID-19 mortality in the early stages of the pandemic, however, this finding did not sustain in 2021, when the mortality rate is similar to the control group. COVID19 COVID 19 COVID-1 infection (202 2021. . 2021) records unit death sex comorbidities up 41. 41 4 1 4:1) ChiSquare Chi Square Fishers Fisher s study 17101 17 101 17,10 hospitalized 13 0.76% 076 0 76 (0.76% 5 IQR (IQR 43.064.0 430640 43.0 64.0 43 64 43.0;64.0 202 46.063.5 460635 46.0 63.5 46 63 46.0;63.5 (PLHIV differences inhospital 27.9% 279 27 9 (27.9 vs 17.7% 177 7 0.049, 0049 0.049 , 049 0.049) 25.0% 250 25 (25.0 25.1% 251 0.999. 0999 0.999 999 0.999) pandemic however group COVID1 COVID- (20 4:1 1710 10 17,1 0.76 07 (0.76 064 43.064. 43064 430 43. 640 64. 6 43.0;64. 20 063 46.063. 46063 460 46. 635 63. 46.0;63. 27.9 2 (27. 17.7 004 0.04 04 25.0 (25. 25.1 099 0.99 99 (2 4: 171 17, 0.7 (0.7 06 43.064 4306 43.0;64 46.063 4606 46.0;63 27. (27 17. 00 0.0 25. (25 09 0.9 ( 0. (0. 43.06 43.0;6 46.06 46.0;6 (0 43.0; 46.0;
3.
Dados de Vida Real sobre o Uso da Hidroxicloroquina ou da Cloroquina Combinadas ou Não à Azitromicina em Pacientes com Covid-19: Uma Análise Retrospectiva no Brasil Covid19 Covid 19 Covid-19 Covid1 1 Covid-1 Covid-
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Souza-Silva, Maíra Viana Rego
; Pereira, Daniella Nunes
; Pires, Magda Carvalho
; Vasconcelos, Isabela Muzzi
; Schwarzbold, Alexandre Vargas
; Vasconcelos, Diego Henrique de
; Pereira, Elayne Crestani
; Manenti, Euler Roberto Fernandes
; Costa, Felício Roberto
; Aguiar, Filipe Carrilho de
; Anschau, Fernando
; Bartolazzi, Frederico
; Nascimento, Guilherme Fagundes
; Vianna, Heloisa Reniers
; Batista, Joanna d’Arc Lyra
; Machado-Rugolo, Juliana
; Ruschel, Karen Brasil
; Ferreira, Maria Angélica Pires
; Oliveira, Leonardo Seixas de
; Menezes, Luanna Silva Monteiro
; Ziegelmann, Patricia Klarmann
; Tofani, Marcela Gonçalves Trindade
; Bicalho, Maria Aparecida Camargos
; Nogueira, Matheus Carvalho Alves
; Guimarães-Júnior, Milton Henriques
; Aguiar, Rúbia Laura Oliveira
; Rios, Danyelle Romana Alves
; Polanczyk, Carisi Anne
; Marcolino, Milena Soriano
.
Resumo Fundamento Apesar da ausência de evidência mostrando benefícios da hidroxicloroquina e da cloroquina combinadas ou não à azitromicina no tratamento da covid-19, esses medicamentos têm sido amplamente prescritos no Brasil. Objetivos Avaliar desfechos, incluindo moralidade hospitalar, alterações eletrocardiográficas, tempo de internação, admissão na unidade de terapia intensiva, e necessidade de diálise e de ventilação mecânica em pacientes hospitalizados com covid-19 que receberam cloroquina ou hidroxicloroquina, e comparar os desfechos entre aqueles pacientes e seus controles pareados. Métodos Estudo multicêntrico retrospectivo do tipo coorte que incluiu pacientes com diagnóstico laboratorial de covid-19 de 37 hospitais no Brasil de março a setembro de 2020. Escore de propensão foi usado para selecionar controles pareados quanto a idade, sexo, comorbidades cardiovasculares, e uso de corticosteroides durante a internação. Um valor de p<0,05 foi considerado estatisticamente significativo. Resultados Dos 7850 pacientes com covid-19, 673 (8,6%) receberam hidroxicloroquina e 67 (0,9%) cloroquina. A idade mediana no grupo de estudo foi 60 (46-71) anos e 59,1% eram mulheres. Durante a internação, 3,2% dos pacientes apresentaram efeitos adversos e 2,2% necessitaram de interromper o tratamento. Alterações eletrocardiográficas foram mais prevalentes no grupo hidroxicloroquina/cloroquina (13,2% vs. 8,2%, p=0,01), e o prolongamento do intervalo QT corrigido foi a principal diferença (3,6% vs. 0,4%, p<0,001). O tempo mediano de internação hospitalar foi maior no grupo usando CQ/HCQ em relação aos controles (9,0 [5,0-18,0] vs. 8,0 [4,0-14,0] dias). Não houve diferenças estatisticamente significativas entre os grupos quanto a admissão na unidade de terapia intensiva (35,1% vs. 32,0%; p=0,282), ventilação mecânica invasiva (27,0% vs. 22,3%; p=0,074) ou mortalidade (18,9% vs. 18,0%; p=0,682). Conclusão Pacientes com covid-19 tratados com cloroquina ou hidroxicloroquina apresentaram maior tempo de internação hospitalar, em comparação aos controles. Não houve diferença em relação a admissão em unidade de terapia intensiva, necessidade de ventilação mecânica e mortalidade hospitalar. covid19, covid19 covid 19, 19 covid-1 3 2020 sexo cardiovasculares p005 p 0 05 p<0,0 significativo 785 8,6% 86 8 6 (8,6% 0,9% 09 9 (0,9% 4671 46 71 (46-71 591 59 1 59,1 mulheres 32 2 3,2 22 2,2 hidroxicloroquinacloroquina 13,2% 132 13 (13,2 vs 82 8,2% p=0,01, p001 p=0,01 , 01 p=0,01) 3,6% 36 (3,6 04 4 0,4% p<0,001. p0001 p<0,001 . 001 p<0,001) CQHCQ CQ HCQ 9,0 90 (9, 5,018,0 50180 5,0 18,0 5 18 [5,0-18,0 80 8, 4,014,0 40140 4,0 14,0 14 [4,0-14,0 dias. dias dias) 35,1% 351 35 (35,1 32,0% 320 p=0,282, p0282 p=0,282 282 p=0,282) 27,0% 270 27 (27,0 22,3% 223 p=0,074 p0074 074 18,9% 189 (18,9 18,0% 180 p=0,682. p0682 p=0,682 682 p=0,682) covid1 covid- 202 p00 p<0, 78 8,6 (8,6 0,9 (0,9 467 7 (46-7 59, 3, 2, 13,2 (13, 8,2 p=0,0 3,6 (3, 0,4 p000 p<0,00 00 9, (9 018 5,018, 5018 50 5, 18, [5,0-18, 014 4,014, 4014 40 4, 140 14, [4,0-14, 35,1 (35, 32,0 p028 p=0,28 28 27,0 (27, 22,3 p=0,07 p007 07 18,9 (18, p068 p=0,68 68 20 p0 p<0 (8, 0, (0, (46- 13, (13 p=0, (3 ( 5,018 501 [5,0-18 4,014 401 [4,0-14 35, (35 32, p02 p=0,2 27, (27 22, (18 p06 p=0,6 p< (8 (0 (46 (1 p=0 5,01 [5,0-1 4,01 [4,0-1 (2 (4 p= [5,0- [4,0- [5,0 [4,0 [5, [4, [5 [4 [
Abstract Background Despite no evidence showing benefits of hydroxychloroquine and chloroquine with or without azithromycin for COVID-19 treatment, these medications have been largely prescribed in Brazil. Objectives To assess outcomes, including in-hospital mortality, electrocardiographic abnormalities, hospital length-of-stay, admission to the intensive care unit, and need for dialysis and mechanical ventilation, in hospitalized COVID-19 patients who received chloroquine or hydroxychloroquine, and to compare outcomes between those patients and their matched controls. Methods A retrospective multicenter cohort study that included consecutive laboratory-confirmed COVID-19 patients from 37 Brazilian hospitals from March to September 2020. Propensity score was used to select matching controls by age, sex, cardiovascular comorbidities, and in-hospital use of corticosteroid. A p-value <0.05 was considered statistically significant. Results From 7,850 COVID-19 patients, 673 (8.6%) received hydroxychloroquine and 67 (0.9%) chloroquine. The median age in the study group was 60 years (46 - 71) and 59.1% were women. During hospitalization, 3.2% of patients presented side effects and 2.2% required therapy discontinuation. Electrocardiographic abnormalities were more prevalent in the chloroquine/hydroxychloroquine group (13.2% vs. 8.2%, p=0.01), and the long corrected QT interval was the main difference (3.6% vs. 0.4%, p<0.001). The median hospital length of stay was longer in the HCQ/CQ + AZT group than in controls (9.0 [5.0, 18.0] vs. 8.0 [4.0, 14.0] days). There was no statistical differences between groups in intensive care unit admission (35.1% vs. 32.0%; p=0.282), invasive mechanical ventilation support (27.0% vs. 22.3%; p=0.074) or mortality (18.9% vs. 18.0%; p=0.682). Conclusion COVID-19 patients treated with chloroquine or hydroxychloroquine had a longer hospital length of stay, when compared to matched controls. Intensive care unit admission, invasive mechanical ventilation, dialysis and in-hospital mortality were similar. COVID19 COVID 19 COVID-1 treatment Brazil inhospital lengthofstay, lengthofstay length-of-stay laboratoryconfirmed laboratory confirmed 3 2020 sex comorbidities corticosteroid pvalue p value 005 0 05 <0.0 significant 7850 7 850 7,85 8.6% 86 8 6 (8.6% 0.9% 09 9 (0.9% 46 (4 71 591 59 1 59.1 women hospitalization 32 2 3.2 22 2.2 discontinuation chloroquinehydroxychloroquine 13.2% 132 13 (13.2 vs 82 8.2% p=0.01, p001 p=0.01 , 01 p=0.01) 3.6% 36 (3.6 04 4 0.4% p<0.001. p0001 p<0.001 . 001 p<0.001) HCQCQ HCQ CQ 9.0 90 (9. 5.0, 50 5 [5.0 18.0 180 18 80 8. 4.0, 40 [4.0 14.0 140 14 days. days days) 35.1% 351 35 (35.1 32.0% 320 p=0.282, p0282 p=0.282 282 p=0.282) 27.0% 270 27 (27.0 22.3% 223 p=0.074 p0074 074 18.9% 189 (18.9 18.0% p=0.682. p0682 p=0.682 682 p=0.682) similar COVID1 COVID- 202 00 <0. 785 85 7,8 8.6 (8.6 0.9 (0.9 ( 59. 3. 2. 13.2 (13. 8.2 p00 p=0.0 3.6 (3. 0.4 p000 p<0.00 9. (9 5.0 [5. 18. 4.0 [4. 14. 35.1 (35. 32.0 p028 p=0.28 28 27.0 (27. 22.3 p=0.07 p007 07 18.9 (18. p068 p=0.68 68 20 <0 78 7, (8. 0. (0. 13. (13 p0 p=0. (3 p<0.0 5. [5 4. [4 35. (35 32. p02 p=0.2 27. (27 22. (18 p06 p=0.6 < (8 (0 (1 p=0 p<0. [ (2 p= p<0 p<
4.
A fully validated microbiological assay for daptomycin injection and comparison to HPLC method
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Christ, Ana Paula
; Machado, Mariana Souto
; Ribas, Karla Giacomelli
; Schwarzbold, Alexandre Vargas
; Silva, Cristiane de Bona da
; Adams, Andréa Inês Horn
.
Brazilian Journal of Pharmaceutical Sciences
- Journal Metrics
resumo A daptomicina (DPT) é o primeiro lipopeptídeo cíclico disponível para comercialização. Possui atividade frente a bactérias gram-positivas, incluindo cepas resistentes. O objetivo deste trabalho foi desenvolver e validar um ensaio microbiológico turbidimétrico para quantificar a daptomicina na forma injetável. Empregou-se delineamento 3x3, nas concentrações de 1,0; 2,0 e 4,0 µg/mL. Como micro-organismo teste foi usado Staphylococcus aureus ATCC 6538p, e Meio para Antibióticos nº 3 foi empregado como meio de cultura. A validação do método demonstrou que o ensaio foi linear (r=0,9995), preciso (RSD=2,55%), exato (recuperação de 100,48 ± 2,11%) e robusto. A cinética de degradação em meio alcalino foi avaliada, indicando que a daptomicina segue cinética de primeira ordem nessa condição. A análise das soluções degradadas mostrou que os produtos de degradação da daptomicina não possuem atividade antimicrobiana. O bioensaio foi comparado com o método por CLAE previamente desenvolvido e não houve diferença significativa entre ambos (p<0,05). O método mostrou-se apropriado para o controle de qualidade da daptomicina injetável.
abstract Daptomycin (DPT) was the first lipopeptide antibiotic available for commercialization. It is active against gram-positive bacteria, including resistant strains. This work aimed to develop and validate a turbidimetric microbiologic assay to determine daptomycin in an injectable form. A 3x3 design was employed, at concentrations of 1, 2 and 4.0 µg/mL. The microorganism test used was Staphylococcus aureus ATCC 6538p, and Antibiotic Medium 3 was used as the culture medium. Method validation demonstrated that the bioassay was linear (r=0.9995), precise (RSD=2.58%), accurate (recovery 100.48± 2.11%), and robust. Degradation kinetics was also performed in an alkaline medium, indicating that daptomycin degradation follows first order kinetics under these conditions. The analyses of degraded solutions showed that daptomycin degradation products do not possess bactericidal activity. The bioassay was compared to HPLC method that was previously developed and no significant difference was found between them (p>0.05). The method proved to be appropriate for daptomycin injection quality control.
https://doi.org/10.1590/S1984-82502015000400003
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