Considerations unique to pediatrics for clinical trial design in hospital-acquired pneumonia and ventilator-associated pneumonia.

Background. A need exists for new antimicrobial agents to treat neonates, infants, and children for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) caused by nosocomial antibiotic-resistant pathogens. Current and clear guidance on approval of new agents for all pediatric age groups is lacking. Methods. Studies on HAP and VAP in the neonatal and pediatric age groups were collected using PubMed (National Library of Medicine). Published articles were reviewed for pediatric-specific definitions of HAP and VAP, diagnostic techniques, rates of disease, risk factors, characteristics, and outcomes. Results. Definitions of HAP and VAP in neonatal and pediatric age groups vary considerably. No well-studied, sensitive, and specific microbiologic testing techniques exist. Morbidity and mortality associated with VAP in neonates, infants, and children have been documented. Conclusions. Investigation and approval of new agents for HAP and VAP in all pediatric age groups is needed. A uniform definition of HAP and VAP is required that is relevant for clinical trials and balances the risks of experimental therapy and sampling procedures for study patients with potential benefits for both the patient under investigation and the hospitalized children who may develop nosocomial pneumonia.