Pneumonia Clinical Trial
Official title:
Community Case Management of Chest Indrawing Pneumonia With Oral Amoxicillin in Children Aged 2-59 Months Old by Community Oriented Resources Persons (CORPs) in Niger State, Nigeria
Verified date | September 2018 |
Source | Malaria Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 191 |
Est. completion date | August 31, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 59 Months |
Eligibility |
Inclusion Criteria: - Chest indrawing pneumonia Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Nigeria | Piakoro & Lapai Local Government Areas | Minna | Niger |
Lead Sponsor | Collaborator |
---|---|
Malaria Consortium | World Health Organization |
Nigeria,
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. Lance — View Citation
Countdown to 2015. Fulfilling the Health Agenda for Women and Children: The 2014 Report. World Health Organization and UNICEF, 2013.
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. — View Citation
Källander 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. — View Citation
Källander 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. — View Citation
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. Erratum in: Lancet. 2016 Jun 18;387(10037):2506. Erratum in: Lancet. 2015 Jan 31;385(9966):420. — View Citation
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. Erratum in: PLoS One. 2015;10(4):e0126997. — View Citation
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. — View Citation
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. Review. — View Citation
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 — View Citation
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. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of children with chest indrawing pneumonia followed up by CHWs | The proportion of children enrolled with chest indrawing pneumonia who were seen and reassessed by a CHW 3 days after the initial visit | By day 3 | |
Secondary | Number of children with clinical relapse of pneumonia | The proportion of children enrolled who were clear of pneumonia symptoms (fast breathing and chest indrawing) on the day 6 visit with any of the following on day 15: Appearance of any danger sign (as per above) Chest indrawing Fever =37.5°C Fast breathing (as per WHO definition) |
Between day 7 and 15 | |
Secondary | Number of caregivers who find outpatient management of chest indrawing pneumonia acceptable for their child | The proportion of children enrolled whose caregivers administered a correct daily dose of antibiotics for the correct frequency and duration | 15 days after enrolment |
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