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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Boston University
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT01192789
First received: August 31, 2010
Last updated: October 12, 2010
Last verified: March 2010
  Purpose

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.

Condition Intervention
Severe Pneumonia
Drug: Amoxicillin
Other: Referral to Health facility

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

    1. No pneumonia
    2. Pneumonia
    3. Severe pneumonia
    4. 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.


Enrollment: 4070
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention
Severe Pneumonia Treatment by LHWs with Amoxicillin at 90mg/kg/day for severe pneumonia
Drug: Amoxicillin
LHWs treat severe pneumonia with oral amoxicillin at 90 mg/kg/day.
Other Names:
  • Ospamox
  • Amoxil Forte
Control
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 2 to 59 months who present to LHWs with severe pneumonia.
  • Informed consent given by a legal guardian.

Exclusion Criteria:

  • Very severe disease.
  • Persistent vomiting.
  • Parental or caretaker refusal to participate in the study.
  • Children currently being treated for non-severe pneumonia who advance to severe pneumonia.
  • Suspected or known kerosene oil ingestion.
  • Prior enrollment in the study within 2 weeks of last follow up
  • Children with severe malnutrition . Children with severe diarrhea with signs of dehydration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192789

Locations
Pakistan
Aga Khan University Research Office, Matiari
Matiari, Sidh, Pakistan
Sponsors and Collaborators
Aga Khan University
World Health Organization
Boston University
Investigators
Principal Investigator: Zulfiqar ZB Bhutta, MBBS, PhD Aga Khan University
  More Information

No publications provided by Aga Khan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Zulfiqar Ahmed Bhutta, Aga Khan University
ClinicalTrials.gov Identifier: NCT01192789     History of Changes
Other Study ID Numbers: 665-Ped/ERC-06
Study First Received: August 31, 2010
Last Updated: October 12, 2010
Health Authority: Ethical Review Committee, Aga Khan University, Karachi: Pakistan

Keywords provided by Aga Khan University:
Severe pneumonia
Pneumonia
Lady health workers
Amoxicillin
Treatment failure
Injectable Antibiotics
Referral treatment
Health Facility
Under five children
home based management
community case management

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014