MedTrace Logo

Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age

NCT01192789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4070

Last updated 2017-05-22

No results posted yet for this study

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.

Conditions

  • Severe Pneumonia

Interventions

DRUG

Amoxicillin

LHWs treat severe pneumonia with oral amoxicillin at 90 mg/kg/day.

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.

Sponsors & Collaborators

Principal Investigators

  • Zulfiqar ZB Bhutta, MBBS, PhD · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192789 on ClinicalTrials.gov