|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02878031 |
|
Date of registration:
|
17/08/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Community Case Management of Chest Indrawing Pneumonia
|
|
Scientific 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 |
|
Date of first enrolment:
|
October 2016 |
|
Target sample size:
|
191 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02878031 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Nigeria
| | | | | | | |
|
Contacts
|
|
Name:
|
Karin Kallander, MSc, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Malaria Consortium |
|
|
Name:
|
Ebenezer Baba, MD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Malaria Consortium |
| |
|
Key inclusion & exclusion criteria
|
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)
Age minimum:
2 Months
Age maximum:
59 Months
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pneumonia
|
|
Intervention(s)
|
|
Drug: Oral amoxicillin for CI pneumonia
|
|
Primary Outcome(s)
|
|
Number of CHWs appropriately managing chest indrawing pneumonia
[Time Frame: At day of enrolment]
|
|
Number of participants with clinical treatment failure
[Time Frame: By day 3 to 6]
|
|
Secondary Outcome(s)
|
|
Number of children with clinical relapse of pneumonia
[Time Frame: Between day 7 and 15]
|
|
Number of children with chest indrawing pneumonia followed up by CHWs
[Time Frame: By day 3]
|
|
Number of caregivers who find outpatient management of chest indrawing pneumonia acceptable for their child
[Time Frame: 15 days after enrolment]
|
|
Secondary ID(s)
|
|
HQGMP1611887
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|