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Community Case Management of Chest Indrawing Pneumonia

NCT02878031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2018-09-20

No results posted yet for this study

Summary

This one-arm safety intervention study is aimed at increasing access to treatment of pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups and recording their findings in case report forms. CORPs will also be involved in improving care seeking for pneumonia in children by training them to conduct health education sessions for men and women in their respective communities.

The primary objective is to assess if CORPs can safely and appropriately manage chest indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The primary outcomes will be the proportion of children under five with chest indrawing pneumonia who were managed appropriately by CORPs and the clinical treatment failure of chest indrawing pneumonia. Secondary outcomes will include proportion of children with chest indrawing followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and clinical relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia disappeared by day 6. Approximately 308 children 2-59 months of age with chest indrawing pneumonia would be needed for this safety intervention study.

Conditions

Interventions

DRUG

Oral amoxicillin for CI pneumonia

CHW management of chest indrawing (CI) pneumonia in children 2-59 months old using oral amoxicillin, given in the following age specific dosage: 2 months ≤ children age \<12 months (4 - \<10kg): one (1) tablet 250mg dispersible amoxicillin twice daily (morning and evening) for 5 days. 12 months≥ children age \<3 years (10 kg - \<14 kg): two (2) tablets 250mg dispersible amoxycillin taken twice daily (morning and evening) for 5 days. ≥ 3 years of age children \<5 years (14kg - 19kg): three (3) tablets 250mg dispersible amoxycillin taken twice daily (morning and evening) for 5 days.

Sponsors & Collaborators

Principal Investigators

  • Karin Kallander, MSc, PhD · Malaria Consortium

  • Ebenezer Baba, MD, MPH · Malaria Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-05-30
Completion
2018-08-31

Countries

  • Nigeria

Study Locations

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Entities

Diseases
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 NCT02878031 on ClinicalTrials.gov