Abstract
BackgroundFast breathing pneumonia is characterized by tachypnoea in the absence of danger signs and is mostly viral in etiology. Current guidelines recommend antibiotic therapy for all children with fast breathing pneumonia in resource limited settings, presuming that most pneumonia is bacterial. High quality clinical trial evidence to challenge or support the continued use of antibiotics, as recommended by the World Health Organization is lacking.Methods/designThis is a randomized double blinded placebo-controlled non-inferiority trial using parallel assignment with 1:1 allocation ratio, to be conducted in low income squatter settlements of urban Karachi, Pakistan. Children 2–59 months old with fast breathing, without any WHO-defined danger signs and seeking care at the primary health care center are randomized to receive either three days of placebo or amoxicillin. From prior studies, a sample size of 2430 children is required over a period of 28 months. Primary outcome is the difference in cumulative treatment failure between the two groups, defined as a new clinical sign based on preset definitions indicating illness progression or mortality and confirmed by two independent primary health care physicians on day 0, 1, 2 or 3 of therapy. Secondary outcomes include relapse measured between days 5–14. Modified per protocol analysis comparing hazards of treatment failure with 95 % confidence intervals in the placebo arm with hazards in the amoxicillin arm will be done.DiscussionThis study will provide evidence to support or refute the use of antibiotics for fast breathing pneumonia paving a way for guideline change.Trial registrationClinical Trials (NIH) Register NCT02372461
Highlights
Fast breathing pneumonia is characterized by tachypnoea in the absence of danger signs and is mostly viral in etiology
World Health Organization (WHO)-defined pneumonia, a spectrum of clinical signs and symptoms varying from isolated fast breathing to presence of danger signs, is an important cause of child morbidity and mortality in low resource countries [1]
With the advent of Haemophilus Influenza type b (Hib) and pneumococcal vaccine in the Expanded Program of Immunization, there is protection against two most common bacterial pathogens of bacterial pneumonia. This has resulted in far smaller proportions of children with lower respiratory tract illnesses (LRTI) having a bacterial etiology and, as a corollary, more having benign viral infections [1, 8, 9]
Summary
Fast breathing pneumonia is characterized by tachypnoea in the absence of danger signs and is mostly viral in etiology. The WHO has recommended antibiotic prescription guidelines to cover the probability that most children with pneumonia-like symptoms have bacterial infections [2]. With the advent of Haemophilus Influenza type b (Hib) and pneumococcal vaccine in the Expanded Program of Immunization, there is protection against two most common bacterial pathogens of bacterial pneumonia. This has resulted in far smaller proportions of children with LRTI having a bacterial etiology and, as a corollary, more having benign viral infections [1, 8, 9]. Vaccine study for three doses of Hib has demonstrated the vaccine effectiveness in reduction of pneumonia from 62 %–70 % among Pakistani children [10], and pneumococcal vaccine studies are currently underway
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