RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia
Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
Burden: Pneumonia remains the leading infectious cause of death accounting for 920,000
children under five around the world. This means a loss of over 2,500 child lives every day,
or over 100 every hour. Since 2000, the number of child deaths caused by pneumonia has
decreased by 47 percent. The tremendous progress made is due in part to the rapid roll-out of
vaccines, better nutrition, and improved care-seeking and treatment for symptoms. However,
pneumonia hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%),
and measles (85%).
Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case
management is one of the three most effective interventions to reduce pneumonia deaths in
children. It is also noted that the cost-effectiveness of these interventions in the national
health system needs urgent assessment. It was suggested to find out means to reduce hospital
stay without compromising the quality of care.
Relevance: The main purpose of the study is to compare the efficacy of two doses of
parenteral Amoxicillin plus single-dose Gentamicin compared to four doses of parenteral
Ampicillin plus single-dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or
injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be
discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive a once-daily
dose of injection Gentamicin for a total of 5 days. It is anticipated that this modified
therapy will reduce the hospitalization stay of children with severe pneumonia and would
therefore be relevant in countries with the resource-poor settings. By reducing the
hospitalization period, this therapy has the potentials to reduce hospital-acquired
infection.
Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus
single-dose Gentamicin will be no more than that of four doses of injectable Ampicillin plus
single-dose Gentamicin in the management of children between 2 months to 59 months
hospitalized for WHO classified severe pneumonia.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh