Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine
the impact of using Lady Health Workers (LHW) of National Program for Family Planning and
Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on
treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm
receive a refresher in standard pneumonia case management. LHWs in the intervention arm
receive standard training that is enhanced to include training in the recognition of severe
pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC),
administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced
pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia
or standard case management and referral to the nearest health facility for treatment
(control). Process indicators reflecting the LHW's ability to assess, classify and treat
pneumonia in the intervention group and cost-effectiveness data is also being collected.
Primary Hypothesis:
Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia
delivered by LHWs in the community will result in a reduction in treatment failure among
children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with
those referred for care by the LHW.
Secondary Hypotheses:
1. The proportion of treatment failure, [persistence of lower chest indrawing (LCI) or need
for second line treatment between day 3 and day 14], will be less in the intervention
arm compared with the control arm.
2. LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old
children, and adequately recognize and refer children who present with danger signs
during initial antimicrobial therapy.