FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2775142203> ?p ?o ?g. }

• W2775142203 endingPage "244" @default.
• W2775142203 startingPage "231" @default.
• W2775142203 abstract "There are very few options to treat multidrug-resistant bacterial infections in children. A major barrier is the duration and complexity of regulatory trials of new antibiotics. Extrapolation of safety data from adult trials could facilitate drug development for children. We performed a systematic review on the safety of antibiotic clinical trials (CTs) in children (0–18 years) to evaluate the overall quality of safety trials conducted in children and to determine if age-specific adverse events (AEs) could be identified for specific antibiotic classes. We searched the MEDLINE, Cochrane CENTRAL, and ClinicalTrials.gov electronic databases for trials conducted between 2000 and 2016. All trials in which safety was declared a primary or secondary endpoint were included. Exclusion criteria were (1) topical or inhalational route of administration; (2) non-infectious conditions; (3) administration for prophylaxis rather than treatment; (4) selected population (i.e. cystic fibrosis, malignancies, HIV and tuberculosis); and (5) design other than randomized controlled trials. Trials reporting data on both adults and children were included only if paediatric results were reported separately. Two authors independently extracted the data. To assess the quality of published trials, the Extension for harms for Consolidated Standards of Reporting Trials (CONSORT) Statement 2004 was used. In order to quantitatively assess the rate of developing AEs by drug class, the numbers of overall and body-system-specific AEs were collected for each study arm, and then calculated per single drug class as median and interquartile range (IQR) of the proportions across CTs. The AEs most frequently reported were compared in the meta-analysis by selecting the CTs on the most represented drug classes. Eighty-three CTs were included, accounting for 27,693 children. Overall, 69.7% of CONSORT items were fully reported. The median proportion of children with any AE was 22.5%, but did not exceed 8% in any single body system. Serious drug-related AEs and drug-related discontinuations were very rare (median 0.3 and 0.9%, respectively). Limitations included the inability to stratify by age group, particularly neonates. Overall, AEs in paediatric antibiotic CTs were predictable and class-specific, and no unexpected (age-specific) side effects were identified. Smaller, open-label, dose-finding, high-quality, single-arm pharmacokinetic trials seem potentially sufficient for certain common antibiotic classes, extrapolating well-established safety profiles determined from large adult efficacy trials. This approach could reduce duration and enhance subsequent registration of urgently needed new antibiotics. This will need to be combined with enhanced methods of pharmacovigilance for monitoring of emerging AEs in routine clinical practice." @default.
• W2775142203 created "2017-12-22" @default.
• W2775142203 creator A5010067946 @default.
• W2775142203 creator A5011457547 @default.
• W2775142203 creator A5035868819 @default.
• W2775142203 creator A5044933203 @default.
• W2775142203 creator A5062909007 @default.
• W2775142203 creator A5066353178 @default.
• W2775142203 creator A5082087451 @default.
• W2775142203 date "2017-12-07" @default.
• W2775142203 modified "2023-10-08" @default.
• W2775142203 title "Evaluating Safety Reporting in Paediatric Antibiotic Trials, 2000–2016: A Systematic Review and Meta-Analysis" @default.
• W2775142203 cites W1594005940 @default.
• W2775142203 cites W163241231 @default.
• W2775142203 cites W1861512778 @default.
• W2775142203 cites W1910023637 @default.
• W2775142203 cites W1956798201 @default.
• W2775142203 cites W1967817810 @default.
• W2775142203 cites W1971515284 @default.
• W2775142203 cites W1973427448 @default.
• W2775142203 cites W1979286787 @default.
• W2775142203 cites W1983359820 @default.
• W2775142203 cites W1986360186 @default.
• W2775142203 cites W1987490391 @default.
• W2775142203 cites W1987977747 @default.
• W2775142203 cites W1989961509 @default.
• W2775142203 cites W1990448757 @default.
• W2775142203 cites W1991085983 @default.
• W2775142203 cites W1991907442 @default.
• W2775142203 cites W1996695146 @default.
• W2775142203 cites W2002751898 @default.
• W2775142203 cites W2004207935 @default.
• W2775142203 cites W2005551936 @default.
• W2775142203 cites W2007872832 @default.
• W2775142203 cites W2008083188 @default.
• W2775142203 cites W2014388074 @default.
• W2775142203 cites W2016689461 @default.
• W2775142203 cites W2017949949 @default.
• W2775142203 cites W2018672791 @default.
• W2775142203 cites W2020914593 @default.
• W2775142203 cites W2028161864 @default.
• W2775142203 cites W2031616321 @default.
• W2775142203 cites W2032573793 @default.
• W2775142203 cites W2038481270 @default.
• W2775142203 cites W2038571957 @default.
• W2775142203 cites W2048842184 @default.
• W2775142203 cites W2058410626 @default.
• W2775142203 cites W2060239739 @default.
• W2775142203 cites W2062555280 @default.
• W2775142203 cites W2066392287 @default.
• W2775142203 cites W2067942077 @default.
• W2775142203 cites W2069771312 @default.
• W2775142203 cites W2071056522 @default.
• W2775142203 cites W2073443063 @default.
• W2775142203 cites W2074469800 @default.
• W2775142203 cites W2076801253 @default.
• W2775142203 cites W2080114312 @default.
• W2775142203 cites W2088047567 @default.
• W2775142203 cites W2089098476 @default.
• W2775142203 cites W2093338276 @default.
• W2775142203 cites W2094714595 @default.
• W2775142203 cites W2100513835 @default.
• W2775142203 cites W2100970056 @default.
• W2775142203 cites W2102068776 @default.
• W2775142203 cites W2102966610 @default.
• W2775142203 cites W2108526080 @default.
• W2775142203 cites W2110821035 @default.
• W2775142203 cites W2111522467 @default.
• W2775142203 cites W2112269557 @default.
• W2775142203 cites W2118017938 @default.
• W2775142203 cites W2121802390 @default.
• W2775142203 cites W2122393922 @default.
• W2775142203 cites W2124012815 @default.
• W2775142203 cites W2125484828 @default.
• W2775142203 cites W2130825752 @default.
• W2775142203 cites W2131809552 @default.
• W2775142203 cites W2132367212 @default.
• W2775142203 cites W2156815214 @default.
• W2775142203 cites W2162693191 @default.
• W2775142203 cites W2165249998 @default.
• W2775142203 cites W2170498353 @default.
• W2775142203 cites W2181669923 @default.
• W2775142203 cites W2206126013 @default.
• W2775142203 cites W2397268317 @default.
• W2775142203 cites W2400628425 @default.
• W2775142203 cites W2408978281 @default.
• W2775142203 cites W2418123132 @default.
• W2775142203 cites W2461878390 @default.
• W2775142203 cites W2476357808 @default.
• W2775142203 cites W2532590275 @default.
• W2775142203 cites W30806309 @default.
• W2775142203 cites W323229595 @default.
• W2775142203 cites W41627511 @default.
• W2775142203 cites W4206446942 @default.
• W2775142203 doi "https://doi.org/10.1007/s40265-017-0850-x" @default.
• W2775142203 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/29218501" @default.
• W2775142203 hasPublicationYear "2017" @default.
• W2775142203 type Work @default.

• next