Community Case Management of Chest Indrawing Pneumonia

NCT02878031 | Completed Phase 4 DMC

• 1 other identifier: HQGMP1611887
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia

Keywords

Integrated Community Case Management; Community Health Worker; Nigeria

Outcome Measures

Primary Outcomes (2)

• Number of participants with clinical treatment failure

  The proportion of children enrolled with any of the following signs by day 6: * Appearance of a danger sign (unable to drink or breastfeed, convulsions, vomiting after ingestion of food or drink, and abnormally sleepy or difficult to wake) * Hypoxemia (Oxygen saturation ≤90%) * Temperature ≥37.5°C and chest indrawing on day 3 * Temperature ≥37.5°C or chest indrawing alone on day 6 * Change of antibiotic * Death

  By day 3 to 6

• Number of CHWs appropriately managing chest indrawing pneumonia

  Proportion of children with RA verified chest indrawing pneumonia with no referral sign (unable to drink or breastfeed, convulsions, vomiting after ingestion of food or drink, and abnormally sleepy or difficult to wake, malnutrition) who received the correct age-specific amoxicillin dose for 5 days Proportion of children with RA verified chest indrawing pneumonia with suspected referral sign (unable to drink or breastfeed, convulsions, vomiting after ingestion of food or drink, and abnormally sleepy or difficult to wake, malnutrition) who were given pre-referral amoxicillin treatment and were referred to a health facility.

  At day of enrolment

Secondary Outcomes (3)

• Number of children with chest indrawing pneumonia followed up by CHWs

  By day 3

• Number of children with clinical relapse of pneumonia

  Between day 7 and 15

• Number of caregivers who find outpatient management of chest indrawing pneumonia acceptable for their child

  15 days after enrolment

Study Arms (1)

Oral amoxicillin for CI pneumonia

EXPERIMENTAL

Community management of chest indrawing pneumonia using oral amoxicillin by CHWs

Drug: Oral amoxicillin for CI pneumonia

Interventions

Oral amoxicillin for CI pneumonia DRUG

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.

Also known as: Intervention arm

Oral amoxicillin for CI pneumonia

Eligibility Criteria

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

You may qualify if:

• \- Chest indrawing pneumonia

You may not qualify if:

• Convulsions
• Cough for 14 days or more
• Blood in stool
• Fever for last 7 days or more
• Diarrhoea for 14 days or more
• Not able to drink or feed anything
• Unusually sleepy or unconscious
• Vomits everything
• Swelling of both feet
• Red on MUAC strap (severe acute malnutrition)

Sponsors & Collaborators

• Malaria Consortium: lead
• World Health Organization: collaborator

Study Sites (1)

Piakoro & Lapai Local Government Areas

Minna, Niger State, Nigeria

Location

Related Publications (11)

• Countdown to 2015. Fulfilling the Health Agenda for Women and Children: The 2014 Report. World Health Organization and UNICEF, 2013.

  BACKGROUND

• Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.

  PMID: 25280870 BACKGROUND

• Kallander K, Hildenwall H, Waiswa P, Galiwango E, Peterson S, Pariyo G. Delayed care seeking for fatal pneumonia in children aged under five years in Uganda: a case-series study. Bull World Health Organ. 2008 May;86(5):332-8. doi: 10.2471/blt.07.049353.

  PMID: 18545734 BACKGROUND

• Noordam AC, Carvajal-Velez L, Sharkey AB, Young M, Cals JW. Care seeking behaviour for children with suspected pneumonia in countries in sub-Saharan Africa with high pneumonia mortality. PLoS One. 2015 Feb 23;10(2):e0117919. doi: 10.1371/journal.pone.0117919. eCollection 2015.

  PMID: 25706531 BACKGROUND

• Sazawal S, Black RE; Pneumonia Case Management Trials Group. Effect of pneumonia case management on mortality in neonates, infants, and preschool children: a meta-analysis of community-based trials. Lancet Infect Dis. 2003 Sep;3(9):547-56. doi: 10.1016/s1473-3099(03)00737-0.

  PMID: 12954560 BACKGROUND

• Gupta GR. Tackling pneumonia and diarrhoea: the deadliest diseases for the world's poorest children. Lancet. 2012 Jun 9;379(9832):2123-4. doi: 10.1016/S0140-6736(12)60907-6. No abstract available.

  PMID: 22682449 BACKGROUND

• Peterson S, Nsungwa-Sabiiti J, Were W, Nsabagasani X, Magumba G, Nambooze J, Mukasa G. Coping with paediatric referral--Ugandan parents' experience. Lancet. 2004 Jun 12;363(9425):1955-6. doi: 10.1016/S0140-6736(04)16411-8.

  PMID: 15194257 BACKGROUND

• Kallander K, Tomson G, Nsungwa-Sabiiti J, Senyonjo Y, Pariyo G, Peterson S. Community referral in home management of malaria in western Uganda: a case series study. BMC Int Health Hum Rights. 2006 Mar 16;6:2. doi: 10.1186/1472-698X-6-2.

  PMID: 16539744 BACKGROUND

• Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.

  PMID: 23582727 BACKGROUND

• Bari A, Sadruddin S, Khan A, Khan Iu, Khan A, Lehri IA, Macleod WB, Fox MP, Thea DM, Qazi SA. Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial. Lancet. 2011 Nov 19;378(9805):1796-803. doi: 10.1016/S0140-6736(11)61140-9. Epub 2011 Nov 10.

  PMID: 22078721 RESULT

• 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 RESULT

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

• Karin Kallander, MSc, PhD

  Malaria Consortium

  PRINCIPAL INVESTIGATOR

• Ebenezer Baba, MD, MPH

  Malaria Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 25, 2016
• Study Start: October 1, 2016
• Primary Completion: May 30, 2018
• Study Completion: August 31, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

NG (1)