Rev Esp Quimioter 2016, 29(3):130-145

A systematic review of randomized clinical trials published in Malaria Journal between 2008 and 2013  

                    
ELENA MARTÍNEZ-ALONSO, JOSÉ MANUEL RAMOS             

Background. Randomized controlled trials (RCT) are a key component in clinical research and they provide the highest quality clinical results. The objective of this study was to describe the main characteristics of RCTs published in Malaria Journal, including research topics, study population and design, funding sources and collaboration between institutions. This may help researchers and funders define future research priorities in this field.
Methods. A retrospective analysis was performed on the RCTs published in Malaria Journal between January 1, 2008 and December 31, 2013. A key-word search by “Randomized controlled trial” or “Random*” was carried out in PubMed. RCT indexed to MEDLINE were selected for the analysis.
Results. A total of 108 published articles containing RCTs were analysed. Treatment of uncomplicated Plasmodium falciparum malaria (n=45, 41.6%), especially the efficacy and safety of antimalarial drugs, and malaria prevention (n=34, 31.5%) were the two main research topics. The majority of trials were conducted in Africa (62.2%) and Asia (27%) and received external funding (private, 42.3% and/or public, 38.6%). Paediatric population was the primary study group (n=63, 58.3%), followed by adults (n=29, 26.9%). Pregnant women (n=7) and geriatric population (n=1) remain underrepresented. Nearly 75% of trials were conducted in individual subjects and 25% in groups of subjects (cluster RCTs). A considerable collaboration between researchers and institutions is noteworthy
Conclusions. RCTs published in Malaria Journal address a wide range of research topics. Paediatric trials conducted in Africa and Asia are frequently performed, and a significant worldwide collaboration to fight against malaria has been identified.

Rev Esp Quimioter 2016; 29(3):130-145 [pdf]

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Rev Esp Quimioter 2016;29(1):1-7

Current status of drug treatment against the disease caused by the Ebola virus     

                        
JORDI REINA              

The recent epidemic of disease caused by the Ebola virus has highlighted the need to develop specific drugs and have to deal with this entity. According to virological analysis they have been designed to give you some new drugs and are proven to others might be effective against this virus.
The main lines of therapy are based on immunotherapy (convalescent serum of patients and specific monoclonal an-tibodies), antiviral drugs (favipiravir, BCX4430, brincidofovir), interfering RNAs (TKM-Ebola) and antisense oligonucleotides (morpholino phosphorodiamidate) and other drugs no antiviral (clomiphene NSC62914, FGI-103, amiloride and ouabain).
Existing studies are scarce and mainly in animal models and clinical trials have been inconclusive most by the drastic reduction in the number of new cases.
However, progress has been made in the biological knowl-edge of Ebola virus and have been located new therapeutic tar-gets for the future development of specific antiviral.

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Rev Esp Quimioter 2016;29(1):25-31

Dual therapy as an alternative treatment in HIV pretreatred patients: experience in a tertiary hospital     

                        
 LUCIA YUNQUERA-ROMERO, ROCÍO ASENSI-DÍEZ, MACARENA GAJARDO-ÁLVAREZ, ISABEL MUÑOZ-CASTILLO              

Introduction. Dual therapy regimen might be an effective alternative to prevent the occurrence of side effects and comorbidities associated with prolonged treatment with antiretroviral (ARV) and a way of simplification of antiretroviral therapy (ART) to improve adherence in certain patients. It also represents a potential treatment option for patients who have failed previous TAR.
Methods. The aim of the study is to describe the effectiveness, adherence and costs of dual therapy regimen used in pretreated HIV patients in tertiary hospital.
Results. Thirty-eight patients were studied (eight were excluded). Reasons for simplification to dual therapy were previous treatment toxicity (40%), simplification (36.67%) and virological rescue (20%). The dual therapy regimens most used were: IP/r + INSTIs (26.67%), IP/r + NRTIs (23.33%), IP/r + NNR-TIs (23.33%), IP/r+ CCR5 (16.66%) e INSTIs + NNRTIs (10%). ARV more used were darunavir/ritonavir (DRV/r) + raltegravir (23.33 %); DRV/r + lamivudine (20%) y DRV/r + etravirine (16.67 %). Adherence was 86.79% before switching to dual therapy and 96.27% after switching. The cost savings of switching to dual therapy of these patients was € 3,635.16.
Discussion. Dual therapy with IP/r might be an effective alternative to selected treatment experienced patients compared with conventional therapy.

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Rev Esp Quimioter 2016,29(1):40-43

Adherence to international recommendations in the fight against antimicrobial resistance – Substantial difference between outpatient consumption in Spain and Denmark     

                        

SARA MALO, MARÍA JOSÉ RABANAQUE, LARS BJERRUM              

Introduction. Increasing antibiotic resistance represents a major public health threat that jeopardises the future treatment of bacterial infections. This study aims to describe the adherence to recommendations proposed by the World Health Organization (WHO) Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR), in Spain and Denmark, and to analyse the relation between the outpatient use of Critically Important Antimicrobials (CIA) and the bacterial resistance rates to these agents.
Material and methods. The Antimicrobial consumption interactive database (ESAC-Net) and Antimicrobial resistance interactive database (EARS-Net) provided data on outpatient use (2010-2013) of CIA (fluoroquinolones, macrolides, and 3rd and 4th generation cephalosporins) and the percentages of isolates of the main pathogens causing serious infections, resistant to these agents.
Results. The use of cephalosporins and fluoroquinolones, as well as the percentage of bacteria resistant, is higher in Spain than in Denmark. Although consumption of macrolides in both countries is similar, the proportion of Streptococcus pneumoniae resistant to macrolides is significantly higher in Spain.
Conclusion. The high outpatient consumption of CIA agents in Spain deviates substantially from the WHO recommendations. Moreover, it has the effect of elevated rates of antimicrobial resistance, that are lower in Denmark.

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Rev Esp Quimioter 2016;29(1):8-14

Ertapenem therapy for pneumonia requiring hospital admission in elderly people     

                        

ARTURO ARTERO, ÁNGEL ATIENZA, SARA CORREA, IAN LÓPEZ, ALEJANDRA FAUS, FRANÇESC PUCHADES, MANUEL MADRAZO             

 

 

Background. Few studies examined ertapenem for the treatment of pneumonia. This study aims to compare ertapenem with other antibiotics commonly used for the treatment of pneumonia requiring hospital admission in elderly patients in daily clinical practice.
Methods. We conducted an observational, retrospective case-control study, between January 2011 and January 2014, in a university hospital. Patients ≥65 years of age admitted to the hospital with pneumonia treated with ertapenem were included as cases. A control patient treated with antibiotics other than ertapenem, matched for age and pneumonia severity index (PSI), was enrolled for each case. Hospital mortality was the primary outcome.
Results. A total of 150 patients with a mean age of 84.1 years were studied. Ninety percent of patients had pneumonia PSI grade IV-V and 82.7% had one or more comorbidities. Healthcare-associated pneumonia (HCAP) and aspiration pneumonia were significantly higher in the ertapenem group (66.7% vs. 24.0%, p < 0.001 and 73.3% vs. 54.7%, p < 0.017, respectively), whereas malignancy was most common in the control group. There was no difference in the hospital mortality rate between ertapenem and control groups (20.0% vs. 20.0%, p = 0.500), after adjusting for HCAP, aspiration pneumonia and malignancy. Transfer from hospital to hospital at home was significantly higher in the ertapenem group (25.3% vs. 9.3%, p = 0.09).
Conclusions. Ertapenem is as effective as other antibiotics commonly used for the treatment of pneumonia requiring hospital admission in elderly people. Ertapenem is associated with a higher transfer to hospital at home.

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Rev Esp Quimioter 2016;29(1):15-24

Bacteraemia and infection of the vascular catheter in the haematology patient: positioning and management based on the Delphi method     

                        

JOSE RAMÓN AZANZA-PEREA, JAVIER LÓPEZ-JIMÉNEZ, ROCÍO PARODY-PORRAS, MIGUEL SALAVERT-LLETÍ, CARLOS SOLANO, DAVID VALCÁRCEL, CARLOS VALLEJO-LLAMAS, LOURDES VÁZQUEZ-LÓPEZ,  PABLO RIVAS-GONZÁLEZ               

Introduction. Infectious complications are an important cause of morbidity and mortality in haematological patients with febrile neutropenia. The aim of this study was to develop a consensus document of recommendations to optimize the management of febrile neutropenic patients with haematological or vascular catheter infections in areas where there is no solid scientific evidence.
Materials and Methods. After reviewing the scientific evidence, a scientific committee composed of experts in haematology and infectious diseases developed a survey with 55 statements. A two- round modified Delphi method was used to achieve consensus.
Results. The online survey was answered by 52 experts in the field of haematology and infectious diseases. After two rounds of evaluation, a consensus was possible in 43 of the 55 statements (78.2%): 40 in agreement and 3 in disagreement. Recommendations are given related to empirical antibiotic treatment of patients with febrile neutropenia, mechanisms of action, toxicity and synergism of antibiotics in this context, modifications of antibiotic treatment in the course of febrile neutropenia, and the management of central vascular catheter infections in the haematological setting.
Conclusions. There is a high degree of agreement among experts on some controversial issues concerning the management of febrile neutropenia and catheter infection in hematologic patients. This agreement has resulted in recommendations that may be useful in clinical practice.

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Rev Esp Quimioter 2016, 29(2):69-75

A comparison of the efficacy of piperacillin-tazobactam and cefoperazone-sulbactam therapies in the empirical treatment of patients with febrile neutropenia     

                        

AYNUR AYNIOGLU, BIRSEN MUTLU, ABDULLAH HACIHANEFIOGLU             

  

Introduction. Empirical antibiotic therapy in neutropenic patients presenting with fever plays a significant role in reducing mortality related to infection. Empirical therapies with broad-spectrum intravenous bactericidal, anti-pseudomonal antibiotics are accepted treatments for febrile neutropenic patients. The aim of this study was to compare the efficacy of piperacillin-tazobactam (PIP-TAZO) and cefoperozone-sulbactam (CS) therapies in adult patients with haematological malignancies presenting with neutropenic fever in a prospective study design.
Methodology. Patients with haematological malignancies (leukaemia, lymphoma, multiple myeloma, and myelodysplastic syndrome) were recruited from June 2010–May 2013.  Participants were over 18 years old, with an absolute neutrophil count (ANC) of less than 500/mm³ following chemotherapy or expected to have an ANC less than 500/mm³ in the first 48 h post-chemotherapy, and with an oral body temperature ≥ 38.3°C at a single measurement or 38.0°C after 1-h monitoring. Patients were randomised to the two treatment groups. The initial empirical therapy comprised PIP-TAZO (4.5 g/6 h/day, IV) and CS (2 g/8 h/day, IV).
Results. The overall success rate was 61% with CS and 49% with PIP-TAZO (p =0.247). Factors affecting the treatment success included a neutrophil count <100/mm3, being in the relapse/refractory stage of malignancy, and the presence of a microbiologically documented infection (p <0.05).
Conclusion. PIP-TAZO and CS monotherapies are equally effective and safe for the empirical treatment of febrile neutropenic patients.

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Rev Esp Quimioter 2016, 29(2):76-85

Knowledge and attitudes of healthcare workers towards a suspect case of Ebola virus disease     

                        

FRANCISCO J. GÓMEZ-ROMERO,  J. MANUEL GÓMEZ-GARCÍA, MERCEDES ARENCIBIA-JIMÉNEZ, JOSÉ ANTONIO DELGADO-DE LOS REYES, RUTH SARMIENTO-SEMPERE, ISIDRO GARCÍA-ABAD, RAMÓN VICEDO-CANO, GERARDO PÉREZ-TORREGROSA, JUAN FRANCISCO NAVARRO-GRACIA             

  

Introduction. The last outbreak of the Ebola virus disease, was a precedent to demonstrate the necessary training of healthcare personnel for possible eventualities of suspected cases of infectious diseases. It is required to study the level of qualification of healthcare workers in such situations.
Methods. Descriptive study using post-workshop survey of healthcare workers in a Valencian Community health department on acquired knowledge and skills after training.
Results and conclusions. Healthcare personnel received an overall passing score on the post-workshop survey, but with differences in occupational categories and different blocks of training. The ratings could be considered deficient in some cases. It should be reviewed periodically training health personnel and calibrate such training to the resources availa-ble for proper operation.

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Rev Esp Quimioter 2016, 29(2):99-104

Development of a web application for recording bacterial etiologic agents and their antimicrobial susceptibility to improve the treatment of urinary tract infections and monitor resistance to antibiotics     

                        

FRANCISCO GÓMEZ-PALOMO, ANTONIO SORLÓZANO-PUERTO, CONSUELO MIRANDA-CASAS, JOSÉ MARÍA RODRÍGUEZ-RODRÍGUEZ, JOSÉ MARÍA NAVARRO-MARÍ, JOSÉ GUTIÉRREZ-FERNÁNDEZ             

Introduction. We describe the development of a web platform that provides an updated record of the etiology and antimicrobial susceptibility of the different microorganisms responsible for urinary tract infections.
Material and Methods. The MicrobDinamyc system (Francisco Soria Melguizo, SA, Madrid, Spain) is employed for the management of information derived from the urine culture results. The web application database automatically gathers the results of urine cultures conducted in the laboratory.
Results. The user can consult the distribution of bacterial etiologies and antimicrobial susceptibilities in the different clinical settings during a specific time window.
Conclusions. Using susceptibility data obtained in previous studies and stored on the web platform, it is possible to deduce the clinical activity of a given antibiotic in a specific setting.

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Rev Esp Quimioter 2016, 29(2):86-90

Surveillance of antimicrobial susceptibility of Escherichia coli producing urinary tract infections in Galicia (Spain)     

                        

MERCEDES TREVIÑO, ISABEL LOSADA, BEGOÑA FERNÁNDEZ-PÉREZ, AMPARO COIRA, MARÍA F. PEÑA-RODRÍGUEZ, XURXO HERVADA Y GRUPO DE ESTUDIO DE LA SOGAMIC PARA EL ESTUDIO DE RESISTENCIAS EN GALICIA             


Introduction. Escherichia coli is the microorganism responsible for most of the community-acquired urinary tract infections (UTI). Our purpose was to determine the susceptibility of E. coli associated with UTI in Galicia and consider the most appropriate antibiotics for empirical treatment.
Methods. Retrospective study during the period 2011- 2012 of the isolation of E. coli in urine samples from almost all the Galician population. Demographic variables, minimum inhibitory concentration, and reading data were collected: amoxicillin-clavulanate, cefotaxime, gentamicin, amikacin, ciprofloxacin, cotrimoxazole, nitrofurantoin and fosfomycin. The identification and susceptibility studies were mainly conducted by automated systems. The interpretation of the results was performed according to CLSI criteria.
Results. During the study period 55,046 E. coli were isolated in UTI. The percentages of resistance were: cotrimoxazole, 30%; ciprofloxacin, 33%; amoxicillin-clavulanate, 23% and 10% for 3rd generation cephalosporins. Fosfomycin and nitrofurantoin showed the highest activity with more than 96% of susceptibility in our study. The linear trend of resistance regarding age was statistically significant (p <0.0001) as it was regarding males (p <0.00001) for all antibiotics.
Conclusions. In Galicia, the most active antibiotics against E. coli associated with UTI are fosfomycin and nitrofurantoin so they should be considered as empirical treatment of choice by the community-acquired UTI not complicated by E. coli.

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