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

NCT01192789 | Completed DMC

• 1 other identifier: 665-Ped/ERC-06
• Study Type: interventional
• Target: 4,070
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

Severe pneumonia; Pneumonia; Lady health workers; Amoxicillin; Treatment failure; Injectable Antibiotics; Referral treatment; Health Facility; Under five children; home based management; community case management

Outcome Measures

Primary Outcomes (1)

• 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.

  At day 6

Secondary Outcomes (4)

• 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.

  Between day 7 and 14

• LHW's correct assessment and classification of ARI

  Day 1 (enrollment day)

• LHWs correct treatment of severe pneumonia

  Day 1

• LHWs ability to refer the case of severe pneumonia.

  Day 1 to day 14

Study Arms (2)

Intervention

OTHER

Severe Pneumonia Treatment by LHWs with Amoxicillin at 90mg/kg/day for severe pneumonia

Drug: Amoxicillin

Control

OTHER

LHWs refer the severe pneumonia case to local health facility or private practitioner.

Other: Referral to Health facility

Interventions

Amoxicillin DRUG

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

Also known as: Ospamox, Amoxil Forte

Intervention

Referral to Health facility OTHER

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.

Control

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator
• Boston University: collaborator

Study Sites (1)

Aga Khan University Research Office, Matiari

Matiari, Sidh, Pakistan

Location

Related Publications (2)

• Ahmed S, Ariff S, Muhammed S, Rizvi A, Ahmed I, Soofi SB, Bhutta ZA. Community case management of fast-breathing pneumonia with 3 days oral amoxicillin vs 5 days cotrimoxazole in children 2-59 months of age in rural Pakistan: A cluster randomized trial. J Glob Health. 2022 Dec 29;12:04097. doi: 10.7189/jogh.12.04097.

  PMID: 36579494 DERIVED

• Soofi S, Ahmed S, Fox MP, MacLeod WB, Thea DM, Qazi SA, Bhutta ZA. Effectiveness of community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Matiari district, rural Pakistan: a cluster-randomised controlled trial. Lancet. 2012 Feb 25;379(9817):729-37. doi: 10.1016/S0140-6736(11)61714-5. Epub 2012 Jan 27.

  PMID: 22285055 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zulfiqar ZB Bhutta, MBBS, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Director, Centre of Excellence in Women and Child Health

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

PA (1)