Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age
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.
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.
- 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.
- 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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cluster Randomized Trial of Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age in Hala and Matiari District, Pakistan|
- The development of clinical treatment failure at day 6 among those children initially evaluated for ARI needing assessment (ANA) by a LHW at the domiciliary level. [ Time Frame: At day 6 ] [ Designated as safety issue: No ]
- Clinical treatment relapse of severe pneumonia between day 7 to 14 among children who have resolved their WHO-defined severe pneumonia (resolution of cough, fever and LCI) prior to day 6. [ Time Frame: Between day 7 and 14 ] [ Designated as safety issue: No ]
- LHW's correct assessment and classification of ARI [ Time Frame: Day 1 (enrollment day) ] [ Designated as safety issue: No ]
Classification of ARI
- No pneumonia
- Severe pneumonia
- very severe disease
- LHWs correct treatment of severe pneumonia [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- LHWs ability to refer the case of severe pneumonia. [ Time Frame: Day 1 to day 14 ] [ Designated as safety issue: No ]LHWs refer the case of severe pneumonia in control arm on day 1 and in intervention in case of treatment failure.
|Study Start Date:||February 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Severe Pneumonia Treatment by LHWs with Amoxicillin at 90mg/kg/day for severe pneumonia
LHWs treat severe pneumonia with oral amoxicillin at 90 mg/kg/day.
LHWs refer the severe pneumonia case to local health facility or private practitioner.
Other: Referral to Health facility
LHWs refer the severe pneumonia case to local health facility or private practitioner. In case of refused referral , treat the case with oral cotrimoxazole for 7 days.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01192789
|Aga Khan University Research Office, Matiari|
|Matiari, Sidh, Pakistan|
|Principal Investigator:||Zulfiqar ZB Bhutta, MBBS, PhD||Aga Khan University|