Jartti T, Söderlund-Venermo M, Hedman K, Ruuskanen O, Mäkelä MJ New molecular virus detection methods and their clinical value in lower respiratory tract infections in children. Paediatr Respir Rev. 2013 Mar;14(1):38-45. doi: 10.1016/j.prrv.2012.04.002. Epub 2012 May 5. Review.
Korppi M, Remes S, Heiskanen-Kosma T Serum procalcitonin concentrations in bacterial pneumonia in children: a negative result in primary healthcare settings. Pediatr Pulmonol. 2003 Jan;35(1):56-61.
Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study. Lancet. 2007 Feb 10;369(9560):482-90.
Reinhart K, Karzai W, Meisner M Procalcitonin as a marker of the systemic inflammatory response to infection. Intensive Care Med. 2000 Sep;26(9):1193-200. Review.
Rhedin S Establishment of childhood pneumonia cause in the era of pneumococcal conjugate vaccines. Lancet Respir Med. 2016 Jun;4(6):423-4. doi: 10.1016/S2213-2600(16)30067-4. Epub 2016 Apr 21.
Sambursky R, Shapiro N Evaluation of a combined MxA and CRP point-of-care immunoassay to identify viral and/or bacterial immune response in patients with acute febrile respiratory infection. Eur Clin Respir J. 2015 Dec 10;2:28245. doi: 10.3402/ecrj.v2.28245. eCollection 2015.
Tuuminen T, Suomala P, Koskinen JO Evaluation of the automated multianalyte point-of-care mariPOC® test for the detection of influenza A virus and respiratory syncytial virus. J Med Virol. 2013 Sep;85(9):1598-601. doi: 10.1002/jmv.23660.
Zar HJ, Barnett W, Stadler A, Gardner-Lubbe S, Myer L, Nicol MP Aetiology of childhood pneumonia in a well vaccinated South African birth cohort: a nested case-control study of the Drakenstein Child Health Study. Lancet Respir Med. 2016 Jun;4(6):463-72. doi: 10.1016/S2213-2600(16)00096-5. Epub 2016 Apr 21. Erratum in: Lancet Respir Med. 2016 Oct;4(10 ):e50.
Trial of Respiratory Infections in Children for Enhanced Diagnostics
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
