Status:
COMPLETED
A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
University of Nairobi
London School of Hygiene and Tropical Medicine
Conditions:
Pneumonia
Eligibility:
All Genders
2-59 years
Phase:
PHASE3
Brief Summary
Pneumonia is one of the top causes of death in children aged below 5. More than 10% of children with severe pneumonia die. We are not sure that the currently recommended antibiotics used in children w...
Detailed Description
Pneumonia is one of the leading causes of death among young children with more than 10% of children aged under-five with severe pneumonia dying. The World Health Organisation (WHO) guidelines recommen...
Eligibility Criteria
Inclusion
- Age 2 to 59 months.
- History of cough or difficulty breathing and signs of severe pneumonia based on WHO 2013 criteria
- Admitted to any one of the study hospitals.
- Informed consent provided by the parents/guardian.
Exclusion
- Children presenting in cardiorespiratory arrest requiring emergency basic life support (bag-valve-mask ventilation and/or chest compressions).
- Children for whom concurrent condition precludes the use of the first-line antibiotics for severe pneumonia such as readmission or meningitis
- Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or amoxicillin-clavulanic acid.
- Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the first-line regimen is considered to have failed
- Previously enrolled in the study.
- For supportive care intervention (Intravenous fluids versus nasogastric feeds): children with absent gag reflex.
- For supportive care intervention (Intravenous fluids versus nasogastric feeds): children unable to maintain oxygen saturations greater 90% on pulse oximetry while receiving supplemental oxygen.
- For supportive care intervention (Intravenous fluids versus nasogastric feeds): children with severe acute malnutrition
- For supportive care intervention (Intravenous fluids versus nasogastric feeds): shock or severe dehydration
- For supportive care intervention (Intravenous fluids versus nasogastric feeds): Child able to feed
- For supportive care intervention (Intravenous fluids versus nasogastric feeds): Vomiting everything
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
4392 Patients enrolled
Trial Details
Trial ID
NCT04041791
Start Date
August 19 2019
End Date
April 5 2024
Last Update
July 8 2024
Active Locations (1)
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1
Machakos Level 5 Hospital
Machakos, Kenya