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Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study.

ABSTRACT: Key goals in the treatment of CAP include early response to treatment and achievement of clinical stability. The US FDA recommends early response endpoints (72 hours after initiation of treatment) in clinical trials for the treatment of community-acquired bacterial pneumonia. REACH (REtrospective Study to Assess the Clinical Management of Patients With Moderate-to-Severe Complicated Skin and Soft Tissue Infections [cSSTI] or CAP in the Hospital Setting) was a retrospective observational study, providing current data on the clinical management and resource burden of CAP in real-life settings in European hospitals. This analysis reviews the characteristics and outcomes of patients showing early positive response to treatment (time to clinical stability [TCS] ?4 days, as assessed by Halm's criteria) compared with patients with later positive response (TCS >4 days).Patients were adults, hospitalized with CAP (2010-2011) and requiring in-hospital treatment with intravenous antibiotics.Of the 2039 patients included in REACH, 585 (28.7%) had TCS assessed by Halm's criteria: 332 (56.8%) showed early response (median 3.0 days), and 253 (43.2%) showed later response to treatment (median 7.0 days). Use of Halm's criteria varied across participating countries, ranging from 0% (Belgium) to 49.1% (UK). Patient characteristics and relevant medical history were similar between the two groups. There were no notable differences in initial antibiotic therapy between groups, except that more early responders had been treated with amoxicillin-clavulanate and amoxicillin monotherapy (22.6%; 7.5%, respectively) than later responders (5.9%; 1.2%, respectively). Initial treatment modification and re-infection or recurrences were less frequent in early responders compared with later responders (14.2% and 3.3% vs. 34.8% and 5.9%, respectively). Early responders had a shorter duration of hospitalization (mean 9.4?±?SD 7.0; median 8.0 days vs. mean 15.6?±?SD 10.5; median 12.0 days, respectively), lower rate of ICU admission (3.3% vs. 21.3%) and shorter duration of ICU stay (mean 6.2?±?SD 5.7; median 4.0 days vs. mean 10.4?±?SD 10.1; median 8.0 days, respectively) compared with later responders. Mortality was low in both groups.Achieving early clinical stabilization in CAP (?4 days) is associated with improved outcomes, lower requirement for initial treatment modification or readmission and lower resource use, compared with a later response.NCT01293435.

SUBMITTER: Blasi F

PROVIDER: S-EPMC3903813 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study.

Blasi Francesco F Ostermann Helmut H Racketa Jill J Medina Jesús J McBride Kyle K Garau Javier J

Respiratory research 20140122

<h4>Background</h4>Key goals in the treatment of CAP include early response to treatment and achievement of clinical stability. The US FDA recommends early response endpoints (72 hours after initiation of treatment) in clinical trials for the treatment of community-acquired bacterial pneumonia. REACH (REtrospective Study to Assess the Clinical Management of Patients With Moderate-to-Severe Complicated Skin and Soft Tissue Infections [cSSTI] or CAP in the Hospital Setting) was a retrospective obs ...[more]

PMID: 24450444

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Project description:BackgroundSevere community-acquired pneumonia (SCAP) is the main cause of mortality in immunocompromised patients. Compared with conventional microbiological tests (CMT), metagenomic next-generation sequencing (mNGS) can quickly and simultaneously detect a wide array of bacteria, viruses, and fungi in an unbiased manner. It is increasingly used for severe respiratory infectious diseases, especially for immunocompromised patients. However, the effects of mNGS-based antimicrobial treatment procedures on clinical outcomes in immunocompromised patients with SCAP have not been evaluated.Methods/designThe MATESHIP study is a prospective, multicenter, parallel-group, open-label, randomized controlled trial from 20 ICUs in university hospitals and academic teaching hospitals across Shandong Province, China. We will enroll 342 immunocompromised patients with early onset SCAP who are admitted to an intensive care unit (ICU). Participants will be randomly allocated to an mNGS-guided treatment group or a conventional treatment group (guided by CMT), according to centrally computer-based block randomization stratified by participating centers. Participants will undergo CMT tests using appropriate lower respiratory tract (LRT) and other necessary specimens, with or without mNGS tests using LRT specimens. The primary outcomes will be: (1) The relative change in Sequential Organ Failure Assessment (SOFA) score from randomization to day 5, day 7, day 10, or the day of ICU discharge/death; and (2) the consumption of antimicrobial agents during ICU stay (expressed as defined daily doses). The secondary outcome measures will be: days from randomization to initiation of definitive antimicrobial treatment; overall antimicrobial agent use and cost; total cost of hospitalization; length of ICU stay; 28- and 90-day mortality; and clinical cure rate. This study hypothesizes that mNGS-guided treatment will decrease the degree of organ dysfunction/failure, the consumption of antimicrobial agents, and mortality, while the cure rate will be increased, and the time to initiation of appropriate therapy will be advanced.DiscussionThe MATESHIP study will evaluate for the first time whether mNGS-guided antimicrobial therapy improves the outcomes of SCAP in an immunocompromised population, and provide high-level evidence on the application of mNGS in the management of this population.Clinical trial registration[ClinicalTrials.gov], identifier [NCT05290454].

Project description:Background: Community-acquired pneumonia (CAP) is one of the most common infectious diseases affecting the respiratory tract and is responsible for a high mortality rate in children less than 5 years of age. The mortality rate due to CAP is much higher in low/middle-income countries than in high-income countries due to malnutrition and different micronutrient deficiencies that weaken the immune system. Aim: The aim of this study was to compare the effects of zinc and vitamin A, as two elements of micronutrient agents, on the recovery rate of children suffering from CAP aged from 6 months to 5 years. The length of hospital stays was also investigated. Method: A comparative, randomized, open-label, controlled, interventional study was carried out among children less than 5 years of age in the pediatric intensive care unit (PICU) diagnosed with CAP who were randomly divided into three groups. In addition to the standard therapy, group 1 was given zinc, group 2 was given vitamin A, and group 3 was the control group, given the standard therapy only. We compared the three groups in terms of recovery rate and hospital stay. Result: The duration of hospitalization following zinc and vitamin A supplementation was reduced by an average of 3.21 days (95% CI: 5.01-1.41, p = 0.01) and 2.43 days (95% CI: 4.29-0.57, p = 0.01), respectively, compared to the control group. In addition, the two groups of vitamin A and zinc supplementation were associated with a shorter duration of pneumonic effusion (p < 0.001) in comparison to the control group. Additionally, there was no significant difference between the effects of zinc and vitamin A when compared to each other in terms of duration of hospital stay and pneumatic effusion. Conclusion: The administration of zinc or vitamin A supplementation proved to be useful as an add-on therapy in community-acquired pneumonia, where it reduced the length of hospital stay and the duration of pneumonic effusion in pneumonic children less than 5 years of age.

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Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study.

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Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study.

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