scholarly journals Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sourabh Dutta ◽  
Sushma Nangia ◽  
Mamta Jajoo ◽  
Geeta Gathwala ◽  
Saudamini Nesargi ◽  
...  
Keyword(s):  
Birth Weight ◽  
Adverse Events ◽  
Neonatal Sepsis ◽  
A Priori ◽  
Public Health Problem ◽  
Data Safety Monitoring Board ◽  
Global Public Health ◽  
Bacterial Sepsis ◽  
Randomized Controlled ◽  
Optimum Duration

Abstract Background Neonatal sepsis is a global public health problem. There is no consensus regarding the optimum duration of antibiotics for culture-proven neonatal sepsis. Published randomized controlled trials (RCTs) comparing shorter versus longer courses of antibiotics provide low-quality evidence with serious risk of bias. We hypothesized that among neonates with uncomplicated culture-proven sepsis, antibiotic duration of 7 days is not inferior to 14 days. Methods This is a multi-centric, parallel-group, stratified, block-randomized, active-controlled, non-inferiority trial with outcome assessment blinded. Stratification is by center and birth weight. Neonates weighing ≥1000 g at birth, with blood-culture-proven sepsis (barring Staphylococcus aureus and fungi), without conditions warranting > 14 days antibiotics, and who clinically remit, are enrolled in the RCT on day 7 of administration of sensitive antibiotics. They are randomly allocated to no further antibiotics (intervention arm: total 7 days) or 7 more days of the same antibiotics (control arm: total 14 days). Allocation is concealed by opaque, sealed envelopes. The primary outcome is “definite or probable relapse” within 21 days after antibiotic completion. Secondary outcomes include definite and probable relapses at various timepoints until day 35 post-randomization, secondary infections, and adverse events. The neonatologist adjudicating probable relapses and lab personnel are blinded. Three hundred fifty subjects will be recruited in each arm, assuming a non-inferiority margin of 7%, one-sided alpha error 5%, and power of 90%. Analysis will be per protocol and by intention-to-treat. An independent Data Safety Monitoring Board monitors adverse events and will perform one interim analysis when 50% of expected primary outcomes have occurred or 50% of subjects have completed follow-up, whichever is earlier. O’Brien-Fleming criteria will be used to stop for mid-term benefit and Pocock’s to stop for mid-term harm. A priori subgroup analyses are planned by birth weight categories, gram-stain status of pathogens, and radiological pneumonia. Discussion This trial will provide evidence to guide practice regarding optimum duration of antibiotics for culture-proven neonatal bacterial sepsis. If a 7-day regime is proved to be non-inferior to a 14-day regime, it is likely to reduce hospital stay, costs, adverse effects of drugs, and nosocomial infections. Trial registration Clinical Trials Registry India CTRI/2017/09/009743. Registered on 13 September 2017.

scholarly journals The relationship between low birth weight and exposure to inhalable particulate matter

2013 ◽  
Vol 29 (6) ◽  
pp. 1101-1108 ◽  
Author(s):  
Rodrigo Romão ◽  
Luiz Alberto Amador Pereira ◽  
Paulo Hilário Nascimento Saldiva ◽  
Patricia Matias Pinheiro ◽  
Alfésio Luiz Ferreira Braga ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Public Health Problem ◽  
Sao Paulo ◽  
São Paulo ◽  
Global Public Health ◽  
Paulo State ◽  
São Paulo State ◽  
Adverse Pregnancy ◽  
The Relationship

Atmospheric pollution is a global public health problem. The adverse effects of air pollution are strongly associated with respiratory and cardiovascular diseases and, to a lesser extent, with adverse pregnancy outcomes. This study analyzes the relationship between exposure to PM10 and low birth weight in the city of Santo André, São Paulo State, Brazil. We included babies born to mothers resident in Santo André between 2000 and 2006. Data on daily PM10 levels was obtained from the São Paulo State Environmental Agency. We performed descriptive analysis and logistic regressions. The prevalence rate of low birth weight was 5.9%. There was a dose-response relationship between PM10 concentrations and low birth weight. Exposure to the highest quartile of PM10 (37,50µg/m³) in the third trimester of pregnancy increased the risk of low birth weight by 26% (OR: 1.26; 95%CI: 1.14-1.40) when compared to the first quartile. The same effect was observed in the remaining trimesters. This effect was observed for ambient particle concentrations that met the current air quality standards.

scholarly journals Tai Chi as an Alternative and Complimentary Therapy for Anxiety

2014 ◽  
Vol 20 (2) ◽  
pp. 143-153 ◽  
Author(s):  
Manoj Sharma ◽  
Taj Haider
Keyword(s):  
Public Health ◽  
Tai Chi ◽  
Public Health Problem ◽  
The United States ◽  
Anxiety Reduction ◽  
Global Public Health ◽  
Inclusion Criteria ◽  
Anxiety Management ◽  
Randomized Controlled ◽  
Global Public Health Problem

Anxiety has become a global public health problem. Tai chi offers one possible way of reducing anxiety. The purpose of this study was to examine studies from 1989 to March 2014 to assess whether tai chi can be an efficacious approach for managing anxiety. A systematic search of Medline, CINAHL, and Alt HealthWatch databases was conducted for quantitative articles involving applications of tai chi for anxiety. A total of 17 articles met the inclusion criteria. Of these, 8 were from the United States, 2 from Australia, 2 from Japan, 2 from Taiwan, and 1 each from Canada, Spain, and China. Statistically significant results of anxiety reduction were reported in 12 of the studies reviewed. Despite the limitations of not all studies using randomized controlled designs, having smaller sample sizes, having different outcomes, having nonstandardized tai chi interventions, and having varying lengths, tai chi appears to be a promising modality for anxiety management.

scholarly journals Pleiotropic genetic influence on birth weight and childhood obesity

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Suvo Chatterjee ◽  
Marion Ouidir ◽  
Fasil Tekola-Ayele
Keyword(s):  
Birth Weight ◽  
Childhood Obesity ◽  
Molecular Mechanisms ◽  
Genetic Correlations ◽  
Public Health Problem ◽  
Genetic Influence ◽  
Global Public Health ◽  
Functional Annotations ◽  
Global Public Health Problem ◽  
Shared Genetic

AbstractChildhood obesity is a global public health problem. Understanding the molecular mechanisms that underlie early origins of childhood obesity can facilitate interventions. Consistent phenotypic and genetic correlations have been found between childhood obesity traits and birth weight (a proxy for in-utero growth), suggesting shared genetic influences (pleiotropy). We aimed to (1) investigate whether there is significant shared genetic influence between birth weight and childhood obesity traits, and (2) to identify genetic loci with shared effects. Using a statistical approach that integrates summary statistics and functional annotations for paired traits, we found strong evidence of pleiotropy (P < 3.53 × 10–127) and enrichment of functional annotations (P < 1.62 × 10–39) between birth weight and childhood body mass index (BMI)/obesity. The pleiotropic loci were enriched for regulatory features in skeletal muscle, adipose and brain tissues and in cell lines derived from blood lymphocytes. At 5% false discovery rate, 6 loci were associated with birth weight and childhood BMI and 13 loci were associated with birth weight and childhood obesity. Out of these 19 loci, one locus (EBF1) was novel to childhood obesity and one locus (LMBR1L) was novel to both birth weight and childhood BMI/obesity. These findings give evidence of substantial shared genetic effects in the regulation of both fetal growth and childhood obesity.

Modulation of the drug resistance by Platonia insignis Mart. extract, ethyl acetate fraction and Morelloflavone/Volkensiflavone (biflavonoids) in Staphylococcus aureus strains overexpressing efflux pump genes

2020 ◽  
Vol 21 ◽  
Author(s):  
Andressa Kelly Ferreira e Silva ◽  
Antonielly Campinho dos Reis ◽  
Emanuelly Elanny Andrade Pinheiroc ◽  
Jonas Nascimento de Sousa ◽  
Felipe Araújo de Alcântara Oliveira ◽  
...  
Keyword(s):  
Natural Products ◽  
Ethyl Acetate ◽  
Native Species ◽  
Efflux Pump ◽  
Public Health Problem ◽  
Ethyl Acetate Fraction ◽  
Multidrug Resistant ◽  
Global Public Health ◽  
Minimal Inhibitory Concentrations ◽  
Subinhibitory Concentrations

Background: Microbial resistance to antibiotics is a global public health problem, which requires urgent attention. Platonia insignis is a native species from the eastern Brazilian Amazon, used in the treatment of burns and wounds. Objectives: To evaluate the antimicrobial activity of the hydroalcoholic extract of P. insignis (PIHA), the ethyl acetate fraction (PIAE), and its subfraction containing a mixture of biflavonoids (BF). Moreover, the effect of these natural products on the antibiotic activity against S. aureus strains overexpressing efflux pump genes was also evaluated. Methods: Minimal inhibitory concentrations were determined against different species of microorganisms. To evaluate the modulatory effect on the Norfloxacin-resistance, the MIC of this antibiotic was determined in the absence and presence of the natural products at subinhibitory concentrations. Inhibition of the EtBr efflux assays were conducted in the absence or presence of the natural products. Results: PIHA showed a microbicidal effect against S. aureus and C. albicans, while PIAE was bacteriosctatic for S. aureus. PIAE and BF at subinhibitory concentrations were able to reduce the MIC of Norfloxacin acting as modulating agents. BF was able to inhibit the efflux of EtBr efflux in S. aureus strains overexpressing specific efflux pump genes. Conclusion: P. inignisis a source of efflux pump inhibitors, including volkensiflavone and morelloflavone which were able to potentiate the Norfloxacin activity by NorA inhibition, being also able to inhibit QacA/B, TetK and MsrA. Volkensiflavone and morelloflavone could be used as adjuvant in the antibiotic therapy of multidrug resistant S. aureus strains overexpressing efflux pumps.

4H-1,3-Benzothiazin-4-one a Promising Class Against MDR/XDR-TB

2019 ◽  
Vol 19 (8) ◽  
pp. 567-578 ◽  
Author(s):  
Marcus Vinicius Nora de Souza ◽  
Thais Cristina Mendonça Nogueira
Keyword(s):  
Treatment Time ◽  
Public Health Problem ◽  
New Drugs ◽  
Global Public Health ◽  
Synthesis Mechanism ◽  
Highly Active ◽  
Latent Disease ◽  
Resistant Strains ◽  
Chemical Class ◽  
Global Public Health Problem

Nowadays, tuberculosis (TB) is an important global public health problem, being responsible for millions of TB-related deaths worldwide. Due to the increased number of cases and resistance of Mycobacterium tuberculosis to all drugs used for the treatment of this disease, we desperately need new drugs and strategies that could reduce treatment time with fewer side effects, reduced cost and highly active drugs against resistant strains and latent disease. Considering that, 4H-1,3-benzothiazin-4-one is a promising class of antimycobacterial agents in special against TB-resistant strains being the aim of this review the discussion of different aspects of this chemical class such as synthesis, mechanism of action, medicinal chemistry and combination with other drugs.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

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